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Assessment of sensory block level during labour epidural analgesia is an essential component of clinical practice and patient safety. Nevertheless, the methods and direction of testing are not standardized. In our hospital, sensory block testing to ice is routinely used, but while some anesthesiologists test the block from a nonanesthetized to an anesthetized area, some do it in the opposite direction. It is unknown how these two different practices affect identification of the sensory block level. The objective of this study was to determine the agreement between these two practices.We enrolled 31 patients admitted to the labour and delivery unit in a prospective cohort study. At their request, labour epidural analgesia was performed as per institutional routine. Sensory block level to ice was assessed using opposite directions by two randomly assigned independent investigators, one and two hours after the loading dose was administered.Sensory block levels to ice assessed from an anesthetized area to a nonanesthetized area were lower than those when assessed with the stimulus applied in the opposite direction, typically one segment lower.Given the small difference detected with both methods, it may be acceptable to use either in clinical practice. Nevertheless, the lack of standardization may have a significant impact when comparing studies involving assessment of sensory block to ice.www.gov (NCT03572439); registered 28 June 2018.RéSUMé: OBJECTIF: L’évaluation du niveau de bloc sensoriel pendant l’analgésie péridurale obstétricale est une composante essentielle de la pratique clinique et de la sécurité des patientes. Néanmoins, les méthodes et l’orientation des tests ne sont pas standardisées. Dans notre hôpital, les tests à la glace des blocs sensoriels sont couramment utilisés, mais alors que certains anesthésiologistes testent le bloc d’une zone non anesthésiée à une zone anesthésiée, certains le font dans la direction opposée. Nous ne savons pas dans quelle mesure ces deux pratiques différentes affectent l’identification du niveau du bloc sensoriel. L’objectif de cette étude était de déterminer la concordance entre ces deux pratiques. MéTHODE: Nous avons recruté 31 patientes admises à l’unité obstétricale dans une étude de cohorte prospective. À leur demande, l’analgésie péridurale obstétricale a été réalisée conformément à la routine institutionnelle. Le niveau du bloc sensoriel tel que mesuré par un test à la glace a été évalué dans les deux directions par deux chercheurs indépendants assignés au hasard, une et deux heures après l’administration de la dose de charge. RéSULTATS: Les niveaux de blocs sensoriels tels que mesurés par un test à la glace évalués d’une zone anesthésiée à une zone non anesthésiée étaient inférieurs à ceux évalués lorsque le stimulus était appliqué dans la direction opposée, habituellement un segment plus bas. DISCUSSION: Compte tenu de la petite différence détectée entre les deux méthodes, il peut être acceptable d’utiliser l’une ou l’autre dans la pratique clinique. Néanmoins, le manque de standardisation peut avoir un impact significatif lors de la comparaison d’études impliquant l’évaluation du bloc sensoriel à l’aide d’un test à la glace. ENREGISTREMENT DE L’éTUDE: www.ClinicalTrials.gov (NCT03572439); enregistrée le 28 juin 2018.

Introduction: Recent studies reported decreased incidence of late onset sepsis in the neonatal intensive care unit (NICU), but it is unclear whether this is also true for late onset meningitis. Recent reports that both meningitis and intraventricular hemorrhage (IVH) are associated with systemic inflammation also raise questions about an association between the 2. Methods: All preterm infants Results: Of 36,573 infants included, 32,198 had no infection, 3,977 had only late onset CPBSI and 398 had late onset meningitis. There was significant decrease in incidence of late onset CPBSI (14%–10%; adjusted odds ratio (AOR) = 0.93; 95% confidence interval [CI] 0.92, 0.95) but not late onset meningitis (1.6%–1.2%; AOR = 0.98; 95% CI 0.94, 1.01). Compared to infants with no IVH grade 3 or above, infants with IVH grade 3, or above had higher odds of late onset meningitis versus no infection (AOR 4.16; 95% CI 3.17, 5.44), and higher odds of late onset meningitis versus late onset CPBSI (AOR 4.11; 95% CI 3.08, 5.50). Conclusions: There was a decreasing trend of late onset CPBSI but not late onset meningitis. An association between late onset meningitis and IVH grade 3 or above was observed. Late onset CPBSI and meningitis may have different risk factors and require different prevention strategies.

OBJECTIVE To evaluate inter-rater agreement for sonographic classification of stomach position (as a surrogate for liver herniation) in fetal left congenital diaphragmatic hernia (LCDH) among: (i) fetal medicine specialists from the North American Fetal Therapy Network (NAFTNet) centers within and without the fetal endoscopic tracheal occlusion (FETO) consortium and in comparison to an expert external reviewer (ER1); and (iii) among two expert ERs (ER1 and ER2). METHODS Forty-eight physicians from 26 NAFTNet centers and 2 ERs were asked to assess 13 sonographic clips of isolated LCDH and classify stomach position as "intra-abdominal," "anterior left chest," "mid to posterior left chest," or "retro-cardiac" based on the classification published by Basta et al.8 Interrater agreement was assessed by determining proportion of stomach position ratings concordant amongst NAFTNet participants and ER1. Agreement for stomach position between ERs was calculated using kappa statistics. RESULTS Agreement for stomach position was 69% (39%-85%; n = 19) and 54% (23%-92%; n = 29) among FETO and non-FETO NAFTNet participants, respectively, when compared to ER1. Most disagreement in stomach position was related to a discrepancy of one position. ERs were in agreement for stomach position in 5 of 13 cases (38.5%) and inter-rater agreement was highest for "anterior" stomach position. CONCLUSION Interrater agreement for stomach position assessment in CDH was poor across NAFTNet and indeed amongst expert reviewers.

BACKGROUND Decision-making deficits in airway emergencies have led to adverse patient outcomes. A cognitive aid would assist clinicians through critical decision-making steps, preventing key action omission. OBJECTIVE We aimed to investigate the effects of a visual airway cognitive aid on decision-making in a simulated airway emergency scenario. DESIGN Randomised controlled study. SETTING Single-institution, tertiary-level hospital in Toronto, Canada from September 2017 to March 2019. PARTICIPANTS Teams consisting of a participant anaesthesia resident, nurse and respiratory therapist were randomised to intervention (N = 20 teams) and control groups (N = 20 teams). INTERVENTION Participants in both groups received a 15-min didactic session on crisis resource management which included teamwork communication and the concepts of cognitive aids for the management of nonairway and airway critical events. Only participants in the intervention group were familiarised, oriented and instructed on a visual airway cognitive aid that was developed for this study. Within 1 to 4 weeks after the teaching session, teams were video-recorded managing a simulated 'cannot intubate-cannot oxygenate' scenario with the aid displayed in the simulation centre. MAIN OUTCOME MEASURES Decision-making time to perform a front-of-neck access (FONA), airway checklist actions, teamwork performances and a postscenario questionnaire. RESULTS Both groups performed similar key airway actions; however, the intervention group took a shorter decision-making time than the control group to perform a FONA after a last action [mean ± SD, 80.9 ± 54.5 vs. 122.2 ± 55.7 s; difference (95% CI) -41.2 (-76.5 to -6.0) s, P = 0.023]. Furthermore, the intervention group used the aid more than the control group (63.0 vs. 28.1%, P

OBJECTIVES To assess short- and long-term outcome in a cohort of fetuses diagnosed with hydrothorax (FHT) which underwent thoracoamniotic shunting in utero, and to examine the antenatal predictors of survival and of survival with normal neurodevelopmental outcome. METHODS This was a retrospective analysis of 132 fetuses that underwent thoracoamniotic shunting at our center between 1991 and 2014. Data were extracted from hospital obstetric and relevant neonatal intensive care and neonatal developmental follow-up databases. Outcomes included survival to discharge and survival with normal neurodevelopmental outcome beyond 18 months. Information on malformations, syndromes and genetic abnormalities were obtained from antenatal, postnatal and pediatric hospital records or by parent report. We compared pregnancy characteristics among those who survived vs non-survivors and among those with normal neurodevelopmental outcome vs those who were abnormal or died. We explored whether there was a trend in survival over the study period. RESULTS The mean gestational age at diagnosis of FHT was 25.6 weeks. The fetus was hydropic at diagnosis in 61% of cases, 69% had bilateral effusions and 55% had bilateral shunts inserted. Other diagnoses were present in 24% of cases, two-thirds of which were discovered only postnatally. There were 16 intrauterine and 30 neonatal deaths, with a 65% survival rate overall. The mean gestational age at delivery of liveborns was 35.4 (range, 26.9-41.6) weeks, and 88/116 (76%) were preterm (

BACKGROUND: Conflicting reports have emerged for rates of preterm births and stillbirths during the COVID-19 pandemic. Most of these reports did not account for natural variation in these rates. We aimed to evaluate variations in preterm birth and stillbirth rates before and during the COVID-19 pandemic in Ontario, Canada. METHODS: We conducted a retrospective cohort study using linked population health administrative databases of pregnant people giving birth in any hospital in Ontario between July 2002 and December 2020. We calculated preterm birth and stillbirth rates. We assessed preterm birth at 22-28, 29-32 and 33-36 weeks' gestation, and stillbirths at term and preterm gestation. We used Laney control P' charts for the 18-year study period (6-mo observation periods) and interrupted time-series analyses for monthly rates for the most recent 4 years. RESULTS: We evaluated 2 465 387 pregnancies, including 13 781 that resulted in stillbirth. The mean preterm birth rate for our cohort was 7.96% (range 7.32%-8.59%). From January to December 2020, we determined that the preterm birth rate in Ontario was 7.87%, with no special cause variation. The mean stillbirth rate for the cohort was 0.56% (range 0.48%-0.70%). From January to December 2020, the stillbirth rate was 0.53%, with no special cause variation. We did not find any special cause variation for preterm birth or stillbirth subgroups. We found no changes in slope or gap between prepandemic and pandemic periods using interrupted time-series analyses. INTERPRETATION: In Ontario, Canada, we found no special cause variation (unusual change) in preterm birth or stillbirth rates, overall or by subgroups, during the first 12 months of the COVID-19 pandemic compared with the previous 17.5 years.

Purpose Conventional palpation techniques for cricothyroid membrane (CTM) identification are inaccurate and unreliable. Ultrasound plays a multi-faceted role in airway management, however there is limited literature around its use for CTM identification prior to cricothyrotomies. This review sought to compare ultrasound to palpation in the general population, identify its indications in subjects with ill-defined neck anatomy, and determine its role in defining neck anatomy. Methods Two reviewers independently assessed titles, abstracts and full-text English articles through the Ovid Medline and EMBASE databases. Studies related to ultrasound for CTM assessment and/or cricothyrotomy in subjects older than 12 years were included. Results Fourteen studies were selected. Compared to palpation, ultrasound has greater accuracy, but longer CTM identification times in those with normal airway anatomy. Interestingly, ultrasound offers comparable times to palpation in patients with difficult airways. Ultrasound also helps define anatomical parameters in the neutral and extended neck positions thereby underscoring the importance of neck positioning during cricothyrotomies and confirming consensus-based incision recommendations set by the Difficult Airway Society. Conclusion Ultrasound appears to be superior to palpation for CTM localization especially in those with difficult airway anatomy and objectively defines neck anatomy. Its pre-emptive use should be incorporated during difficult airway management.

One year of adjuvant trastuzumab is considered the standard treatment for patients with HER2 positive breast cancer. However, a shorter duration of trastuzumab may be associated with reduced costs and side effects. Results from randomized trials with diverse non-inferiority margins comparing one year to a shorter duration of adjuvant trastuzumab are not consistent and have not been systematically reviewed using a non-inferiority meta-analysis approach. We conducted a systematic review and meta-analysis of randomized trials to assess whether a shorter duration of adjuvant trastuzumab was non-inferior to one year of treatment or not. The non-inferiority margin for the meta-analysis was pre-defined as the median of the margins of all the trials included. Data of 11,376 patients from 5 trials were analyzed. Non-inferiority margins in included studies varied from 1.15 to 1.53 with median of 1.29 for HR of DFS. A shorter duration of trastuzumab was non-inferior to one year of therapy for DFS (HR 1.13, 95%CI 1.03–1.24) but inconclusive for OS (HR 1.14, 95%CI 1.00–1.30). In a subgroup analysis for DFS outcome, shorter therapy was non-inferior in patients with ER positive disease (HR 1.10, 95%CI 0.95–1.28) and those with sequential therapy (HR 0.97, 95%CI 0.75–1.27) and when the duration of treatment was 6 months (HR 1.09, 95%CI 0.98–1.22). Although a shorter duration of adjuvant trastuzumab was non-inferior to one year of therapy for DFS in patients with HER2 positive breast cancer based on our HR margin of 1.29, any benefit of a shorter duration comes at a loss of efficacy with an increase in absolute risk up to 3.9% for 5 year DFS. Whether the potential increased risk is clinically acceptable for the benefits of a shorter duration remains debatable., Highlights • Shorter duration of adjuvant trastuzumab in HER2 positive breast cancer is attractive. • Inconsistent results seen from the PHARE and PERSEPHONE trials. • Meta-analysis suggests shorter duration of trastuzumab is non-inferior. • Highlights need for appropriately chosen and applied non-inferiority margin.

For patients with recurrent implantation failure in IVF, histologic or transcriptomic testing of the endometrium during the mid-secretory phase is often considered. Histological dating of endometrial biopsies (Noyes criteria) can determine if endometrial morphology is consistent with the period of receptivity. Alternatively, endometrial tissue can be sent for a commercial Endometrial Receptivity Array (ERA) test which characterizes the gene expression of the endometrium using a panel of 238 genes that have been implicated in endometrial receptivity. This study aimed to compare the two tests to assess their concordance and to examine the ability of the ERA to successfully predict implantation and pregnancy in a subsequent personalized embryo transfer. A retrospective review was done of 97 patients with a history of implantation failure who underwent an ERA, 35 of whom had histologic dating on the same sample. ERA and histology were classified as 'concordant' when samples were receptive by both tests or non-receptive by both tests. The ERA result was then used to personalize the embryo transfer day, and pregnancy rates from the first subsequent frozen transfer cycle were analyzed. The results indicated that there is poor concordance between ERA and histological dating with only 40.0% agreement and a kappa (95%CI) = -0.18 (-0.50, 0.14). According to the ERA, 48.5% of biopsies were receptive, 47.4% were non-receptive and 2.01% were insufficient tissue for analysis. The clinical pregnancy rate in patients shown to be receptive by ERA was 26.7% and non-receptive was 22.5% following the subsequent personalized ET (p = 0.66). This study concludes that there is a high degree of discordance between histological dating of the endometrium and molecular analysis by ERA. There was no evidence of clinical benefit when embryo transfer was personalized according to ERA in patients with a history of implantation failure.

Background and ObjectivesNo evidence of disease activity (NEDA)-4 has been suggested as a treatment target for disease-modifying therapy (DMT) in relapsing-remitting multiple sclerosis (RRMS). However, the ability of NEDA-4 to discriminate long-term outcomes in MS and how its performance compares with NEDA-3 remain uncertain. We conducted a systematic review and meta-analysis to evaluate (1) the association between NEDA-4 and no long-term disability progression in MS and (2) the comparative performance of NEDA-3 and NEDA-4 in predicting no long-term disability progression.MethodsEnglish-language abstracts and manuscripts were systematically searched in MEDLINE, Embase, and the Cochrane databases from January 2006 to November 2021 and reviewed independently by 2 investigators. We selected studies that assessed NEDA-4 at 1 or 2 years after DMT start and had at least 4 years of follow-up for determination of no confirmed disability progression. We conducted a meta-analysis using random-effects model to determine the pooled odds ratio (OR) for no disability progression with NEDA-4 vs EDA-4. For the comparative analysis, we selected studies that evaluated both NEDA-3 and NEDA-4 with at least 4 years of follow-up and examined the difference in the association of NEDA-3 and NEDA-4 with no disability progression.ResultsFive studies of 1,000 patients (3 interferon beta and 2 fingolimod) met inclusion criteria for both objectives. The median duration of follow-up was 6 years (interquartile range: 4–6 years). The prevalence of NEDA-4 ranged from 4.2% to 13.9% on interferon beta therapy and 24.9% to 25.1% on fingolimod therapy. The pooled OR for no long-term confirmed disability progression with NEDA-4 vs EDA-4 was 2.14 (95% confidence interval: 1.36–3.37; I2= 0). We did not observe any significant difference between NEDA-4 and NEDA-3 in the comparative analyses.DiscussionIn patients with RRMS, NEDA-4 at 1–2 years was associated with 2 times higher odds of no long-term disability progression, at 6 years compared with EDA-4, but offered no advantage over NEDA-3.

In the context of a programmed intermittent epidural bolus (PIEB) regimen for labour analgesia, one can identify an upper sensory block level (USBL), defined as the highest dermatome with any altered sensation to cold, and a lower sensory block level (LSBL), defined as the highest dermatome with complete sensory block to cold. This study investigated whether and how these sensory block levels vary within PIEB cycles.We enrolled patients requesting epidural analgesia. An epidural catheter was placed at L2/L3 or L3/L4. A test dose of 3 mL of bupivacaine 0.125% with fentanyl 3.3 µg·mLWe studied 30 patients. The USBL and LSBL achieved their peak value 100 min after the loading dose. The median [interquartile range] USBL was TOnce peak sensory block levels are established, there is no significant variation in the USBL and LSBL within the PIEB cycles.www.gov (NCT04716660); registered 21 January 2021.RéSUMé: OBJECTIF: Dans le contexte du schéma de bolus périduraux intermittents programmés (PIEB) pour l’analgésie du travail, on peut identifier un niveau de bloc sensoriel haut (USBL) défini comme étant le dermatome le plus haut ayant une quelconque modification de la sensation au froid et un niveau de bloc sensoriel bas (LSBL) défini comme étant le dermatome le plus haut ayant un bloc sensoriel complet au froid. Cette étude a cherché à savoir si et comment ces niveaux de blocs sensoriels varient au cours des cycles de PIEB. MéTHODES: Nous avons recruté des patientes demandant une analgésie péridurale. Un cathéter péridural a été placé au niveau L2/L3 ou au niveau L3/L4. Une dose test de 3 mL de bupivacaïne 0,125% avec fentanyl 3,3 µg·ml

The aim of this retrospective cohort study was to study the clinical burden associated with cardio-pulmonary critical decompensations (CPCDs) in preterm neonates and factors associated with mortality. Through the Canadian Neonatal Network (30 tertiary NICUs, 2010-2017), we identified infants 32-week gestational age with CPCDs, defined by "significant exposure" to cardiotropes and/or inhaled nitric oxide (iNO): (1) either therapy for ≥ 3 consecutive days, (2) both for ≥ 2 consecutive days, or (3) any exposure within 2 days of death. Early CPCDs (≤ 3 days of age) and late CPCDs ( 3 days) were examined separately. Outcomes included CPCD-incidence, mortality, and inter-site variability using standardized ratios (observed/adjusted expected rate) and network funnel plots. Mixed-effects analysis was used to quantify unit-level variability in mortality. Overall, 10% of admissions experienced CPCDs (n = 2915). Late CPCDs decreased by ~ 5%/year, while early CPCDs were unchanged during the study period. Incidence and CPCD-associated mortality varied between sites, for both early (0.6-7.5% and 0-100%, respectively) and late CPCDs (2.5-15% and 14-83%, respectively), all p 0.01. Units' late-CPCD incidence and mortality demonstrated an inverse relationship (slope = -2.5, p 0.01). Mixed-effects analysis demonstrated clustering effect, with 6.4% and 8.6% of variability in mortality after early and late CPCDs respectively being site-related, unexplained by available patient-level characteristics or unit volume. Mortality was higher with combined exposure than with only-cardiotropes or only-iNO (41.3%, 24.8%, 21.5%, respectively; p 0.01).Clustering effects exist in CPCD-associated mortality among Canadian NICUs, with higher incidence units showing lower mortality. These data may aid network-level benchmarking, patient-level risk stratification, parental counseling, and further research and quality improvement work.• Preterm neonates remain at high risk of acute and chronic complications; the most critically unwell require therapies such as cardiotropic drugs and inhaled nitric oxide. • Infants requiring these therapies are known to be at high risk for adverse neonatal outcomes and for mortality.• This study helps illuminate the national burden of acute cardio-pulmonary critical decompensation (CPCD), defined as the need for cardiotropic drugs or inhaled nitric oxide, and highlights the high risk of morbidity and mortality associated with this disease state. • Significant nationwide variability exists in both CPCD incidence and associated mortality; a clustering effect was observed with higher incidence sites showing lower CPCD-associated mortality.

To describe the incidence, trends, management's variability and short-term outcomes of preterm infants with severe post-hemorrhagic ventricular dilatation (sPHVD).We reviewed infantslt;33 weeks' gestation who had PHVD and were admitted to the Canadian Neonatal Network between 2010 and 2018. We compared perinatal characteristics and short-term outcomes between those with sPHVD and those with mild/moderate PHVD and those with and without ventriculo-peritoneal (VP) shunt.Of 29,417 infants, 2439 (8%) had PHVD; rate increased from 7.3% in 2010 to 9.6% in 2018 (P = 0.005). Among infants with PHVD, sPHVD (19%) and VP shunt (29%) rates varied significantly across Canadian centers and between geographic regions (P lt; 0.01 and P = 0.0002). On multivariable analysis, sPHVD was associated with greater mortality, seizures and meningitis compared to mild/moderate PHVD.Significant variability in sPHVD and VP shunt rates exists between centers and regions in Canada. sPHVD was associated with increased mortality and morbidities.

To compare short term respiratory outcomes in preterm infants treated with bovine lipid extract surfactant or poractant alfa.Prospective comparative effectiveness cohort study of infants32 weeks' gestational age requiring surfactant in thirteen centers. Each center provided bovine lipid extract surfactant for a set period of time in the year 2019 and then changed to poractant alfa for the remainder of the year. The primary outcome was total duration of respiratory support.968 infants were included. 494 received bovine lipid extract surfactant and 474 received poractant alfa. No difference was observed in the total duration of respiratory support (mechanical ventilation or non-invasive) (median 38 vs 40.5 days), need to re-dose surfactant, bronchopulmonary dysplasia, survival to discharge, or length of admission.In this pragmatic study, we did not identify any difference in short term outcomes between the groups based on the type of surfactant received.

BackgroundNecrotizing enterocolitis (NEC) is the leading cause of death among preterm infants born at MethodsOur prospective multicenter, double-blinded, randomized, controlled trial will include infants born at n = 1549) will receive at least two feeds of fresh human milk (i.e., within 4 h of expression) per day from the time of enrollment until 32 weeks’ corrected age or discharge to home. Infants in the control group (n = 1549) will receive previously frozen human milk following the current standard protocols. Following informed consent, enrolled infants will be randomly allocated to the control or fresh human milk groups. The primary outcome is the composite outcome mortality or NEC ≥ stage 2 at 32 weeks’ corrected age, and the secondary outcomes are mortality, NEC ≥ stage 2, NEC needing surgery, late-onset sepsis, retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), weight gain, change in weight, increase in length, increase in head circumference, time to full enteral feeds, and finally, the number and type of critical incident reports, including feeding errors.DiscussionOur double-blinded, randomized, controlled trial aims to examine whether fresh human milk can improve infant outcomes. The results of this study will impact both Chinese and international medical practice and feeding policy for preterm infants. In addition, data from our study will inform changes in health policy in NICUs across China, such that mothers are encouraged to enter the NICU and express fresh milk for their infants.Trial registrationChinese Clinical Trial Registry; #ChiCTR1900020577; registered January 1, 2019;http://www.chictr.org.cn/showprojen.aspx?proj=34276

Context No head-to-head clinical trials compare contemporary first-line therapies for metastatic renal cell carcinoma (mRCC). A network meta-analysis provides an approach for quantitative analysis. Objective To indirectly compare the efficacy and safety of first-line treatments for mRCC in the intention-to-treat (ITT) population and by clinical risk group. Evidence acquisition An updated systematic review from database inception to February 17, 2019 identified all parallel-group randomized controlled trials assessing first-line therapy for mRCC. “Clinically relevant” studies were selected for a network meta-analysis. Progression-free survival (PFS) was the primary outcome. Overall survival (OS), overall response rate (ORR), and grade 3 and 4 adverse events (AEs) were secondary outcomes. Evidence synthesis We identified 12 relevant trials: 12 reported outcomes for PFS, nine for OS, 10 for ORR, and nine for AEs. In the ITT population, cabozantinib (surface under the cumulative ranking curves [SUCRA] 84%), avelumab plus axitinib (SUCRA 68%), and pembrolizumab plus axitinib (SUCRA 82%) were superior to the other agents for PFS; pembrolizumab plus axitinib appeared superior for OS (SUCRA 95%); and atezolizumab demonstrated the lowest likelihood of AEs (SUCRA 100%). Findings were similar in the intermediate/poor-risk subgroup. Based on the limited data available, avelumab plus axitinib may be preferred in patients with favorable-risk disease. Conclusions The optimal first-line treatment for mRCC appears to differ by efficacy endpoint, toxicity, and clinical risk group. Direct comparative studies remain important in guiding treatment choice. Patient summary Head-to-head comparisons do not exist for the newest treatments of metastatic renal cell carcinoma (mRCC). In an indirect comparison, we found that pembrolizumab plus axitinib and cabozantinib are good options for most patients with mRCC.

Phenylephrine (PE) is currently the vasopressor of choice to prevent and treat spinal-induced hypotension at cesarean delivery (CD). However, its use is often associated with reflex bradycardia. Norepinephrine (NE) has been put forward as an alternative vasopressor during CD due to its ability to treat hypotension while maintaining heart rate (HR). Recent studies have focused on the role of NE used as an infusion with favorable results compared to PE. No studies have compared equipotent bolus doses of PE and NE at CD. We hypothesized that when used in equipotent doses as an intermittent bolus regimen to prevent and treat spinal-induced hypotension, NE would result in a reduction in the incidence of bradycardia compared to PE.This was a double-blind, randomized clinical trial of women undergoing elective CD under spinal anesthesia. Women were randomized to receive either PE 100 µg or NE 6 µg when the systolic blood pressure (SBP) was below baseline. In addition to the randomized treatment, ephedrine was given intravenously to both groups if the SBP was below baseline and the HR60 bpm or if the SBP was80% of baseline for 2 consecutive readings. The primary outcome was bradycardia (HR50 bpm) in the predelivery period. Secondary outcomes included hypotension (SBP80% of baseline), hypertension (SBP120% of baseline), tachycardia (HR120% of baseline), ≥2 episodes of bradycardia, nausea, vomiting, umbilical artery and vein blood gases, and Apgar scores.One hundred twelve patients were randomized. The incidence of bradycardia was lower in the NE group compared to the PE group (10.7% vs 37.5%; P.001; difference [95% confidence interval {CI}], -26.8% [-41.8% to -11.7%]), implying an estimated 71% relative reduction (95% CI, 35%-88%). The distribution of the number of bradycardia episodes was also different between the 2 groups (P = .007). Further testing showed that the patients in the PE group had a higher risk of multiple bradycardia episodes (≥2 episodes) compared to the NE group (19.6% for PE versus 3.6% for NE; P = .008). The proportion of patients requiring rescue boluses of ephedrine was lower in the NE group compared to the PE group (7.2% for NE versus 21.4% for PE; P.03; difference [95% CI], -14.3% [-27.0% to -1.6%]). No differences were observed between the 2 groups in the incidence of other secondary outcomes.When used as an intermittent bolus regimen to prevent and treat spinal-induced hypotension during CD, NE resulted in a significant reduction in the incidence of bradycardia as compared to an equipotent bolus regimen of PE. We conclude that the hemodynamic profile offered by NE during CD is superior to that of PE due to less fluctuations in HR and possibly cardiac output.

Objective: To identify how Family Integrated Care (FICare) affected maternal stress and anxiety. Study Design: This secondary analysis of the FICare cluster randomised controlled trial included infants born between 1 April 2013 and 31 August 2015 at ≤33 weeks’ gestation. Mothers completed the PSS:NICU and STAI questionnaires at enrolment and study day 21. Results: 1383 mothers completed the surveys at one or both time-points. The mean PSS:NICU and STAI scores at day 21 were significantly lower in the FICare mothers than controls (PSS:NICU mean [standard deviation] FICare 2.32 [0.75], control 2.48 [0.78], p = 0.0005; STAI FICare 70.8 [20.0], control 74.2 [19.6], p = 0.0004). The sights and sounds, looks and behaviour, and parental role PSS:NICU subscales and the state and trait STAI subscales were all significantly different between FIC are and controls at day 21. The magnitude of change in all stress and anxiety subscales was greater in the FICare group than controls. These differences remained significant after adjustment for confounders with the greatest change in the parental role (least-squares mean [95% confidence interval] FICare −0.65 [−0.72, 0.57], control −0.31 [−0.38, −0.24], p < 0.0001) and state anxiety subscales. Conclusion: FICare is effective at reducing NICU-related maternal stress and anxiety.

Quality improvement initiatives in neonatology have yielded positive results; however, few programs have demonstrated sustainability. We evaluated an ongoing, national quality improvement initiative (Evidence-based Practice for Improving Quality Phase 3 (EPIQ-3)) on outcomes of preterm neonates with a gestational age (GA) of 220–286weeks (i.e., from 22 weeks and 0 days of gestation to 28 weeks and 6 days of gestation). Data from 7459 neonates admitted to 25 Canadian centers between 2013 and 2017 were studied. Trends in mortality and major morbidities were evaluated. The number of neonates with a GA of 220–236weeks increased from 90 in 2013 to 139 in 2017 without a significant change in any other GA categories. In the entire cohort, the odds of composite outcome of mortality or any major morbidity (adjusted odds ratio (AOR) 0.72, 95% confidence interval (CI) 0.61–0.84) and of necrotizing enterocolitis (AOR 0.66, 95% CI 0.49–0.89) were lower in 2017 than in 2013. When calculated per year, the odds of composite outcome (AOR 0.93, 95% CI 0.89–0.97) and odds of necrotizing enterocolitis (AOR 0.89, 95% CI 0.82–0.96) decreased significantly. Among the subgroup of neonates with a GA of 260–286weeks, the odds of composite outcome (AOR 0.63, 95% CI 0.51–0.79), necrotizing enterocolitis (AOR 0.44, 95% CI 0.26–0.73), and nosocomial infection (AOR 0.64, 95% CI 0.49–0.84) were reduced. The collaborative, multidisciplinary, nationwide EPIQ-3 program improved outcomes of preterm neonates, and the improvement was sustainable over 5 years.

Objective: To evaluate the association of a combined exposure to antenatal steroids and prophylactic indomethacin with the outcome of spontaneous intestinal perforation (SIP) among neonates born at 7 days before birth) exposures. The co-exposure was prophylactic indomethacin. The primary outcome was SIP. Multivariable logistic regression analysis was used to calculate aORs. Results: Among 4720 eligible infants, 4121 (87%) received antenatal steroids and 1045 (22.1%) received prophylactic indomethacin. Among infants exposed to antenatal steroids, those who received prophylactic indomethacin had higher odds of SIP (aOR 1.61, 95% CI 1.14-2.28) compared with no prophylactic indomethacin. Subgroup analyses revealed recent antenatal steroids exposure with prophylactic indomethacin had higher odds of SIP (aOR 1.67, 95% CI 1.15-2.43), but latent antenatal steroids exposure with prophylactic indomethacin did not (aOR 1.24, 95% CI 0.48-3.21), compared with the respective groups with no prophylactic indomethacin. Among those not exposed to antenatal steroids, mortality was lower among those who received prophylactic indomethacin (aOR 0.45, 95% CI 0.28-0.73) compared with no prophylactic indomethacin. Conclusions: In preterm neonates of

Early antibiotic administration is an important modifiable factor in reducing mortality from late-onset bloodstream infections in preterm infants. In a cohort study including 142 infants with non-coagulase negative staphylococcus bloodstream infection at two tertiary neonatal intensive care units, we identified typical practice-related factors that may be targeted to prevent delays in antibiotic administration. Collection of cerebrospinal fluid or urine sample before administering antibiotics, a longer time taken to site a peripheral intravenous catheter among those without pre-existing access, and a longer time taken to administer fluid boluses were associated with a longer than median time to antibiotic administration.

The objective of this study was to investigate the association between systolic, diastolic, and mean blood pressures (SBP, DBP, and MBP) and adverse outcomes in preterm neonates with late-onset sepsis (LOS).This is a two-center retrospective study over 6 years. Neonates35 weeks gestational age (GA) with blood ± cerebrospinal fluid culture positive for organisms other than coagulase-negative Staphylococcus at72 h age were included. Outcome measures were organ dysfunction (ODF) using the predefined criteria and post-ODF mortality (≤7 days from LOS onset). The lowest noninvasive blood pressures (BPs) recorded at baseline (24-48 h pre-LOS) and 0-12, 13-24, 25-36, and 37-48 h post LOS were analyzed.Of 147 neonates, ODF occurred in 70 (48%), of which 20 (29%) died. ODF was associated with a drop in all BP components, starting 0-12 h post-LOS onset (p 0.01 for all); BPs remained unchanged in the non-ODF group. Mortality was associated with a greater reduction in SBP [-13 (-19, -8) vs. -4 (-8, 0); p 0.01] and MBP [-9 (-13, -5) vs. +1 (-1, +4); p = 0.03] 0-12 h post-LOS onset. SBP had a higher area under the curve for mortality than MBP and DBP (0.83, 0.81, and 0.78, respectively). An inverse relation may exist between corrected GA and percentage reduction in SBP from baseline for equivalent risk of death.Reduction in BPs early in illness may identify preterm neonates at the highest risk of ODF and mortality from LOS.Drop in BPs from baseline starting in the immediate post-illness onset period may identify preterm neonates at the highest risk of developing ODF and mortality in LOS. Lowest systolic followed by mean BP measured during the first 12 h of illness provided the highest discriminating ability for LOS-related mortality. Absolute BPs recorded during the first 12 h of illness performed better than relative change from baseline for identifying neonates at risk of LOS-related mortality. The specific BP thresholds identified in this study may inform future therapeutic trials.

IntroductionPatent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in preterm infants and evidence regarding the best treatment approach is lacking. Currently available medical options to treat a PDA include indomethacin, ibuprofen or acetaminophen. Wide variation exists in PDA treatment practices across Canada. In view of this large practice variation across Canadian neonatal intensive care units (NICUs), we plan to conduct a comparative effectiveness study of the different pharmacotherapeutic agents used to treat the PDA in preterm infants.Methods and analysisA multicentre prospective observational comparative-effectiveness research study of extremely preterm infants born Standard dose ibuprofen (10 mg/kg followed by two doses of 5 mg/kg at 24 hours intervals) irrespective of postnatal age (oral/intravenous).Adjustable dose ibuprofen (oral/intravenous) (10 mg/kg followed by two doses of 5 mg/kg at 24 hours intervals if treated within the first 7 days after birth. Higher doses of ibuprofen up to 20 mg/kg followed by two doses of 10 mg/kg at 24 hours intervals if treated after the postnatal age cut-off for lower dose as per the local centre policy).Acetaminophen (oral/intravenous) (15 mg/kg every 6 hours) for 3–7 days.Intravenous indomethacin (0.1–0.3 mg/kg intravenous every 12–24 hours for a total of three doses).OutcomesThe primary outcome is failure of primary pharmacotherapy (defined as need for further medical and/or surgical/interventional treatment following an initial course of pharmacotherapy). The secondary outcomes include components of the primary outcome as well as clinical outcomes related to response to treatment or adverse effects of treatment.Sites and sample sizeThe study will be conducted in 22 NICUs across Canada with an anticipated enrollment of 1350 extremely preterm infants over 3 years.AnalysisTo examine the relative effectiveness of the four treatment strategies, the primary outcome will be compared pairwise between the treatment groups using χ2 test. Secondary outcomes will be compared pairwise between the treatment groups using χ2 test, Student’s t-test or Wilcoxon rank sum test as appropriate. To further examine differences in the primary and secondary outcomes between the four groups, multiple logistic or linear regression models will be applied for each outcome on the treatment groups, adjusted for potential confounders using generalised estimating equations to account for within-unit-clustering. As a sensitivity analysis, the difference in the primary and secondary outcomes between the treatment groups will also be examined using propensity score method with inverse probability weighting approach.Ethics and disseminationThe study has been approved by the IWK Research Ethics Board (#1025627) as well as the respective institutional review boards of the participating centres.Trial registration numberNCT04347720.

Programmed intermittent epidural bolus (PIEB) provides better analgesia for labour pain than continuous epidural infusion does. Nevertheless, commonly used PIEB regimens are associated with high sensory block. We hypothesized that a PIEB technique with slower bolus delivery speed would produce lower sensory levels.We recruited term nulliparous women with singleton pregnancies during the first stage of labour. All participants had an American Society of Anesthesiologists Physical Status score of II-III, had epidural catheters placed at L3/4, and had epidural analgesia maintained with PIEB 10 mL every 40 min using 0.0625% bupivacaine with fentanyl 2 µg·mLWe analyzed data from 90 women. The proportion of women presenting sensory block ≥ T6 at any time was not different between G125 and G250 groups (60.0% vs 64.4%; difference, -4.4%; 95% confidence interval [CI], -24.5 to 15.6; P = 0.66). The median [interquartile range] highest sensory block level was also not different between G125 and G250 groups (T6 [T7-T5] vs T5 [T7-T5], P = 0.39). Women in the G125 group had a lower incidence of hypotension than women in the G250 group did (11.1% vs 33.3%; difference, -22.2%; 95% CI, -38.8 to -5.67; P = 0.01). Quality of analgesia and patient satisfaction were not different between groups.The maintenance of epidural analgesia with a PIEB delivery speed of 125 mL·hrwww.ClinicalTrials.gov (NCT03236298); registered 1 August 2017.RéSUMé: OBJECTIF: L’administration programmée intermittente de bolus périduraux (PIEB, pour programmed intermittent epidural bolus) fournit une meilleure analgésie pour la douleur du travail que l’analgésie péridurale par perfusion continue. Néanmoins, les régimes de PIEB couramment utilisés sont associés à un bloc sensoriel élevé. Nous avons émis l’hypothèse qu’une technique de PIEB avec une vitesse d’administration plus lente du bolus produirait des niveaux sensoriels inférieurs. MéTHODE: Nous avons recruté des femmes nullipares à terme ayant des grossesses uniques au cours de la première étape du travail obstétrical. Toutes les participantes avaient un score de statut physique II-III de l’American Society of Anesthesiologists, des cathéters périduraux placés au niveau L3/4 et une analgésie péridurale maintenue avec des PIEB de 10 mL de bupivacaïne 0,0625 % et de 2 μg·mL

IntroductionAlthough chronic pulmonary hypertension (cPH) secondary to chronic neonatal lung disease is associated with increased mortality and respiratory and neurodevelopmental morbidities, late diagnosis (typically ≥36 weeks postmenstrual age, PMA) and the use of qualitative echocardiographic diagnostic criterion (flat interventricular septum in systole) remain significant limitations in clinical care. Our objective in this study is to evaluate the utility of relevant quantitative echocardiographic indices to identify cPH in preterm neonates, early in postnatal course and to develop a diagnostic test based on the best combination of markers.Methods and analysisIn this ongoing international prospective multicentre observational diagnostic accuracy study, we aim to recruit 350 neonates born Ethics and disseminationEthics approval has been received by the Mount Sinai Hospital Research Ethics Board (REB) (#16-0111-E), Sunnybrook Health Sciences Centre REB (#228-2016), NHS Health Research Authority (IRAS 266498), University of Iowa Human Subjects Office/Institutional Review Board (201903736), Rotunda Hospital Research and Ethics Committee (REC-2019-008), and UBC Children’s and Women’s REB (H19-02738), and is under review at Boston Children’s Hospital Institutional Review Board. Study results will be disseminated to participating families in lay format, presented to the scientific community at paediatric and critical care conferences and published in relevant peer-reviewed journals.Trail registration numberNCT04402645.

To investigate the association of early (±4 hours after onset of bloodstream infection) clinical and laboratory variables with episode-related mortality (7 days).This 2-site retrospective study included 142 neonates born at35 weeks of gestational age with positive blood/cerebrospinal fluid (CSF) culture at72 hours of age from organisms other than coagulase-negative Staphylococcus. Early variables were compared between those with bloodstream infection-related mortality and survivors. Multivariable analysis was conducted for the primary outcome, and the area under the curve (AUC) was estimated for relevant variables.The neonates who died were of lower gestational age at disease onset. After adjusting for relevant variables, lowest mean blood pressure (MBP) (aOR, 0.10; 95% CI, 1.02-1.19) and highest base deficit (aOR, 1.18; 95% CI, 1.06-1.32) were independently associated with mortality. The AUC was 0.87 (95% CI, 0.78-0.96) for base deficit, increasing to 0.91 (95% CI, 0.83-0.99) with the addition of MBP.Low MBP and high base deficit within ±4 hours of bloodstream infection onset identify preterm neonates at risk of mortality.

To assess the association between time of birth and mortality among preterm infants.Population-based study of infants born 22-36 weeks gestation (GA) in Canada from 2010 to 2015 (n = 173 789). Multivariable logistic regression models assessed associations between timing of birth and mortality.Among infants 22-27 weeks GA, evening birth was associated with higher mortality than daytime birth (adjusted odds ratio [AOR] 1.14, 95% CI 1.01-1.29). Among infants 28-32 weeks GA and 33-36 weeks GA, night birth was associated with lower mortality than daytime birth (AOR 0.75, 95% CI 0.59-0.95; AOR 0.78, 95% CI 0.62-0.99, respectively). Sensitivity analysis excluding infants with major congenital anomaly revealed that associations between hour of birth and mortality among infants born 28-32 and 33-36 weeks GA decreased or were not statistically significant.Higher mortality among extremely preterm infants during off-peak hours may suggest variations in available resources based on time of day.

Approximately one in five women will experience severe postoperative pain after Cesarean delivery (CD). Previously, a bedside three-item questionnaire (3-IQ) has shown to predict women experiencing higher evoked pain intensity after CD, with an area under the receiver operator characteristics (ROC) curve of 0.72. We hypothesized that the addition of psychophysical pain tests to the existing 3-IQ would improve the ability to predict severe pain in women undergoing elective CD under spinal anesthesia METHODS: This was a prospective cohort study on women undergoing elective CD under spinal anesthesia. Women were assessed preoperatively using the 3-IQ, pressure algometry (PA) and mechanical temporal summation (TS) response. All women received standard perioperative care, including a multimodal analgesia regimen that included intrathecal fentanyl and morphine. A 0-100 mm visual analogue scale (VAS) was used to assess the severity of pain at rest (VASr) and on movement (VASm) at 24 and 48 hr after surgery. Patient satisfaction and opioid consumption were also recorded. We performed ROC curve analyses to assess whether we could improve the ability to predict our primary outcome of severe pain on movement at 24 hr (VASm24 ≥ 70).We studied 195 women. Median [interquartile range] VASm24 was 53 [32-72] and 28% of patients experienced a VASm24 ≥ 70. The ability to predict a VASm24 ≥ 70 assessed by the area under the ROC curve was 0.64 using the 3-IQ and 0.67 using the 3-IQ combined with TS and PA.The addition of PA and TS to the 3-IQ model resulted in a predictive model that performed similarly to the 3-IQ model alone. Further research is warranted in this area to better predict women at risk of severe pain post CD.RéSUMé: OBJECTIF: Environ une femme sur cinq souffrira de douleur postopératoire sévère après un accouchement par césarienne. Un questionnaire à trois critères (Q3C) administré au chevet de la patiente a déjà été utilisé pour prédire quelles femmes éprouveraient une intensité de douleur évoquée plus élevée après une césarienne, avec une aire sous la courbe ROC de 0,72. Nous avons émis l’hypothèse que l’ajout de tests psychophysiques de douleur au Q3C existant améliorerait notre capacité à prédire la douleur sévère chez les femmes bénéficiant d’une césarienne élective sous rachianesthésie. MéTHODE: Il s’agissait d’une étude de cohorte prospective auprès de femmes bénéficiant d’une césarienne élective sous rachianesthésie. Les femmes ont été évaluées en préopératoire à l’aide du Q3C, de l’algométrie par pression (AP) et de la réponse à une sommation temporale (ST) mécanique. Toutes les femmes ont bénéficié des soins périopératoires standard, ainsi que d’un régime d’analgésie multimodal incluant fentanyl et morphine intrathécaux. Une échelle visuelle analogique (EVA) de 0 à 100 mm a été utilisée pour évaluer la sévérité de la douleur au repos (EVAr) et en mouvement (EVAm) à 24 et 48 heures après la chirurgie. La satisfaction des patientes et la consommation d’opioïdes ont également été enregistrées. Nous avons effectué des analyses de la courbe ROC pour déterminer s’il nous était possible d’améliorer notre capacité à prédire notre critère d’évaluation principal, soit la douleur sévère à la mobilisation à 24 heures (EVAm24 ≥ 70). RéSULTATS: Nous avons étudié 195 femmes. L’EVAm 24 médiane [écart interquartile] était de 53 [32-72] et 28 % des patientes ont noté un score sur l’EVAm24 ≥ 70. La capacité à prédire un score sur l’EVAm24 ≥ 70 tel qu’évalué par la surface sous la courbe ROC était de 0,64 en utilisant le Q3C et de 0,67 en utilisant le Q3C combiné à la ST et l’AP. CONCLUSION: L’ajout de l’AP et de la ST au modèle de Q3C a résulté en un modèle prédictif présentant une performance similaire au modèle de Q3C seul. D’autres recherches sont nécessaires dans ce domaine pour mieux prédire les femmes à risque de douleur sévères après une césarienne.

We studied the programmed intermittent epidural bolus (PIEB) time interval between boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mLIn a double-blind sequential allocation trial using a biased coin up-and-down design to determine the EI90, the PIEB boluses of 2.5 mL of 0.25% bupivacaine plus fentanyl 8 µg·mLIn the 20 women studied, the estimated EI90 was 20 (95% CI, 5.9 to 28.8) min. For the secondary outcomes, we classified women into those assigned to 30 min (16 women) and those assigned to more than 30 min (four women). The median upper sensory block for women in the 30-min group and more than 30 min were T6 (or T5) and T7, respectively. No participants experienced motor block. Hypotension occurred in one patient in the 30-min group.The estimated EI90 for boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mLwww.clinicaltrials.gov (NCT03735771); registered 7 November 2018.RéSUMé: OBJECTIF: Nous avons étudié l’intervalle de temps d’administration programmée de bolus périduraux (PIEB) entre des bolus de 2,5 mL de bupivacaïne 0,25 % avec 8 μg·mL

Objective To determine the antenatal sonographic lung area measurement method in left congenital diaphragmatic hernia (CDH) with the highest interrater agreement among North American Fetal Therapy Network (NAFTNet) centers within and outside the fetoscopic tracheal occlusion (FETO) consortium and in comparison with a European "expert" reviewer (ER). Methods Nineteen members from nine FETO consortium centers and 29 reviewers from 17 non-FETO centers reviewed ultrasound clips of the chest from 13 fetuses with isolated left CDH and were asked to select a static plane for lung area measurement using anteroposterior (AP), longest, and trace methods. Interrater agreement in lung area measurements was determined using intraclass correlation coefficient (ICC). Bland-Altman analysis was used to evaluate mean difference (bias) between NAFTNet reviewers and ER. Results Among FETO centers, agreement was highest using trace (ICC 0.94; 95% CI, 0.83-0.98), followed by longest (ICC 0.89; 95% CI, 0.75-0.97) and lowest for A-P (ICC 0.83; 95% CI, 0.67-0.94). Similar trends were noted in non-FETO centers. When compared with ER, bias was lowest for trace: 14 ± 38 mm2 and 19 ± 36 mm2 for FETO and non-FETO centers, respectively. Conclusion The trace method demonstrated the highest interrater agreement and lowest bias for lung area estimation in left CDH across NAFTNet.

Background Intrauterine insemination (IUI) is the first-line treatment for non-tubal infertility. Injectable gonadotropins are often chosen as adjunctive stimulation to promote the growth of ovarian follicles in IUI cycles. The growing follicles produce estrogen, which induces endometrial proliferation and increased endometrial stripe thickness (EST). The association between EST and pregnancy outcome in gonadotropin stimulated IUI is not well studied. The objective of this study is to determine if EST can predict pregnancy outcome in gonadotropin-stimulated IUI cycles. Methods A retrospective review was conducted of all exclusively gonadotropin-stimulated IUI cycles performed between 2012 and 2015 at an academic fertility clinic. Mean endometrial thickness was compared in positive versus negative cycles using Student T-test. Peak EST values were then divided into four groups of

To assess the feasibility of conducting a study comparing nasal continuous positive airway pressure (nCPAP) or heated, humidified, high flow nasal cannula (HHHFNC) on oral feeding in preterm infants.Randomized controlled pilot study in a level III NICU, of infants' born ≤28°We enrolled 40 infants and 12 completed the study in the nCPAP group versus 13 in the HHHFNC group. Using our respiratory and feeding protocols, we showed overall enrollment and retention rates (95%CI) at 0.66 (0.54, 0.77) and 0.63 (0.48, 0.78), respectively. Breastfeeding rates were 82% in the nCPAP group and 76% in the HHHFNC group. Infants in the HHHFNC group reached full feeds 7 days earlier than those in the nCPAP group.Based on our retention rate, an adequately powered randomized controlled trial can be performed to confirm or refute that HHHFNC is associated with achieving oral feeds earlier.United States National Library of Medicine (www.clinicaltrials.gov) Identifier: NCT02055339. First posted 2/5/2014.

To assess whether Family Integrated Care (FICare) in the neonatal intensive care unit improves maternal chronic physiological stress and child behavior at 18 months of corrected age for infants born preterm.Follow-up of a multicenter, prospective cluster-randomized controlled trial comparing FICare and standard care of children born at33 weeks of gestation and parents, stratified by tertiary neonatal intensive care units, across Canada. Primary outcomes at 18 months of corrected age were maternal stress hormones (cortisol, ie, hair cumulative cortisol [HCC], dehydroepiandrosterone [DHEA]) assayed from hair samples. Secondary outcomes included maternal reports of parenting stress, child behaviors (Internalizing, Externalizing, Dysregulation), and observer-rated caregiving behaviors. Outcomes were analyzed using multilevel modeling.We included 126 mother-child dyads from 12 sites (6 FICare sites, n = 83; 6 standard care sites, n = 43). FICare intervention significantly lowered maternal physiological stress as indicated by HCC (B = -0.22 [-0.41, -0.04]) and cortisol/DHEA ratio (B = -0.25 [-0.48, -0.02]), but not DHEA (B = 0.01 [-0.11, 0.14]). Enrollment in FICare led to lower child Internalizing (B = -0.93 [-2.33, 0.02]) and Externalizing behavior T scores (B = -0.91 [-2.25, -0.01]) via improvements to maternal HCC (mediation). FICare buffered the negative effects of high maternal HCC on child Dysregulation T scores (B = -11.40 [-23.01, 0.21]; moderation). For mothers reporting high parenting stress at 18 months, FICare was related to lower Dysregulation T scores via maternal HCC; moderated mediation = -0.17 (-0.41, -0.01).FICare has long-term beneficial effects for mother and child, attenuating maternal chronic physiological stress, and improving child behavior in toddlerhood.NCT01852695.

Objective: To determine the incidence of chronic lung disease (CLD) in mechanically ventilated infants who were born at

Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use.In this multicentre, cluster-randomised controlled trial, we stratified 26 tertiary NICUs from Canada, Australia, and New Zealand by country and size, and assigned them, using a computer-generated random allocation sequence, to provide FICare or standard NICU care. Eligible infants were born at 33 weeks' gestation or earlier, and had no or low-level respiratory support; parents gave written informed consent for enrolment. To be eligible, parents in the FICare group had to commit to be present for at least 6 h a day, attend educational sessions, and actively care for their infant. The primary outcome, analysed at the individual level, was infant weight gain at day 21 after enrolment. Secondary outcomes were weight gain velocity, high frequency breastfeeding (≥6 times a day) at hospital discharge, parental stress and anxiety at enrolment and day 21, NICU mortality and major neonatal morbidities, safety, and resource use (including duration of oxygen therapy and hospital stay). This trial is registered with ClinicalTrials.gov, number NCT01852695.From Oct 1, 2012, 26 sites were randomly assigned to provide FICare (n=14) or standard care (n=12). One site assigned to FICare discontinued because of poor site enrolment. Parents and infants were enrolled between April 1, 2013, and Aug 31, 2015, with 895 infants being eligible in the FICare group and 891 in the standard care group. At day 21, weight gain was greater in the FICare group than in the standard care group (mean change in Z scores -0·071 [SD 0·42] vs -0·155 [0·42]; p0·0002). Average daily weight gain was significantly higher in infants receiving FICare than those receiving standard care (mean daily weight gain 26·7 g [SD 9·4] vs 24·8 g [9·5]; p0·0001). The high-frequency exclusive breastmilk feeding rate at discharge was higher for infants in the FICare group (279 [70%] of 396) than those in the standard care group (394 [63%] of 624; p=0·016). At day 21, parents in the FICare group had lower mean stress scores than did parents in the standard care group (2·3 [SD 0·8] vs 2·5 [0·8]; p0·00043), and lower mean anxiety scores (70·8 [20·1] vs 74·2 [19·9]; p=0·0045). There were no significant differences between groups in the rates of the secondary outcomes of mortality, major morbidity, duration of oxygen therapy, and duration of hospital stay. Although the safety assessment was not completed, there were no adverse events.FICare improved infant weight gain, decreased parent stress and anxiety, and increased high-frequency exclusive breastmilk feeding at discharge, which together suggest that FICare is an important advancement in neonatal care. Further research is required to examine if these results translate into better long-term outcomes for families.Canadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.

To determine the specific Score of Neonatal Acute Physiology (SNAP-II) cut-off scores associated with outcomes in extremely preterm infants, and to examine its contribution to predictive models that include nonmodifiable birth predictors.Retrospective observational study of 9240 infants born at 22-28 weeks' gestation and admitted to the Canadian Neonatal Network from 2010 to 2015. Outcomes included early and hospital mortality, composite of mortality/morbidity and individual morbidities. The SNAP-II cut-off to predict each outcome was determined using the Youden index. Additional contributions were evaluated using a base model that adjusted for gestational age, birth weight z-score and sex and by comparing the area under the curve (AUC).The mortality/morbidity rate was 63% (5859/9240). Specific SNAP-II cut-offs ranged from 12 to 20 and were associated with each adverse outcome. Adding SNAP-II cut-offs to predictive models that included birth variables significantly improved (p .05) the prediction of early mortality (AUC 0.84 versus 0.79), hospital mortality (AUC 0.80 versus 0.78), mortality/morbidity (AUC 0.76 versus 0.75), and severe neurological injury (AUC 0.69 versus 0.66) but had little or no effect on predictive models for retinopathy of prematurity, bronchopulmonary dysplasia, necrotizing enterocolitis, and nosocomial infection.SNAP-II cut-offs were independently associated with each adverse outcome and using the proposed SNAP-II cut-offs improved the performance of predictive models for certain short-term outcomes.

Infants with restricted growth for age are frequently exposed to insufficient placental circulation and are more likely to develop postnatal complications. Delayed cord clamping at birth for these infants requires further exploration.This study aimed to compare the short-term neonatal outcomes of delayed cord clamping with that of early cord clamping in small for gestational age preterm infants and to explore whether the effects of delayed cord clamping in small for gestational age preterm infants are different from that in non-small for gestational age preterm infants.We conducted a national retrospective cohort study, including infants born at33 weeks' gestation and admitted to the Canadian Neonatal Network units between January 2015 and December 2017. Small for gestational age infants (birthweight of10th percentile for gestational age and sex) who received delayed cord clamping ≥30 seconds were compared with those who received early cord clamping. In addition, non-small for gestational age infants who received delayed cord clamping were compared with those who received early cord clamping. The main study outcomes included composite outcome of mortality or major morbidity, neonatal morbidity rate, mortality rate, peak serum bilirubin, and number of blood transfusions. Multivariable logistic and linear regression models with a generalized estimation equation approach were used to account for the clustering of infants within centers.Overall, 9722 infants met the inclusion criteria. Of those infants, 1027 (10.6%) were small for gestational age. The median (interquartile range) gestational age was 31 weeks (range, 28-32 weeks). After adjusting for potential confounders, delayed cord clamping in small for gestational age infants was associated with a reduction in the composite outcome of mortality or major morbidity (adjusted odds ratio, 0.60; 95% confidence interval, 0.42-0.86) compared with early cord clamping. There was no difference between the 2 groups in peak serum bilirubin. Many associated benefits of delayed cord clamping in small for gestational age infants were similar to those in non-small for gestational age infants.Delayed cord clamping in small for gestational age preterm infants was associated with decreased odds of mortality or major morbidity. Many of the benefits of delayed cord clamping in the small for gestational age preterm infants were similar to those identified in the non-small for gestational age preterm infants.

To examine rates and determinants of mother's own milk (MOM) feeding at hospital discharge in a cohort of infants born very preterm within the Canadian Neonatal Network (CNN).This was a population-based cohort study of infants born at33 weeks of gestation and admitted to neonatal intensive care units (NICUs) participating in the CNN between January 1, 2015, and December 31, 2018. We examined the rates and determinants of MOM use at discharge home among the participating NICUs. We used multivariable logistic regression analysis to identify independent determinants of MOM feeding.Among the 6404 infants born very preterm and discharged home during the study period, 4457 (70%) received MOM or MOM supplemented with formula. Rates of MOM feeding at discharge varied from 49% to 87% across NICUs. Determinants associated with MOM feeding at discharge were gestational age 29-32 weeks compared with26 weeks (aOR 1.56, 95% CI 1.25-1.93), primipara mothers (aOR 2.12, 95% CI 1.86-2.42), maternal diabetes (aOR 0.79, 95% CI 0.66-0.93), and maternal smoking (aOR 0.27, 95% CI 0.19-0.38). Receipt of MOM by day 3 of age was the major predictor of breast milk feeding at discharge (aOR 3.61, 95% CI 3.17-4.12).Approximately two-thirds of infants born very preterm received MOM at hospital discharge, and rates varied across NICUs. Supporting mothers to provide breast milk in the first 3 days after birth may be associated with improved MOM feeding rates at discharge.

Objective To evaluate the disease burden of placental maternal vascular malperfusion pathology in a low-risk nulliparous population and test the hypothesis that a multiparameter model in the second trimester can predict maternal vascular malperfusion with high precision. Methods A single-center, prospective cohort study was conducted in healthy nulliparous women. Maternal vascular malperfusion disease burden was estimated by incidence, relative risk (RR), and population-attributable risk percent. Maternal risk factors, serum biomarkers, Doppler, and placental morphologic ultrasonography were examined in isolation and in combination for prediction of this placental pathology. Results The incidence of maternal vascular malperfusion pathology was 8.4% (72/856). Women with pathology had higher risk of preeclampsia (8.33% compared with 1.79%; RR 4.67, 95% CI 1.85-11.77%; population-attributable risk 23.6%, 95% CI 16.9-31.6%), small for gestational age (SGA) (47.22% compared with 9.45%; RR 5.00, 95% CI 3.6-6.93%; population-attributable risk 25.2%, 95% CI 22.1-28.5%), and the composite of adverse outcomes (defined as SGA or preeclampsia) (47.22% compared with 10.59%; RR 4.46, 95% CI 3.25-6.13; population-attributable risk 22.5%, 95% CI 19.8-25.5%). The combination of parameters was superior to individual modalities alone in predicting maternal vascular malperfusion, but achieved only moderate precision (area under the curve 0.77, 95% CI 0.71-0.84). Conclusion One in 12 healthy nulliparous women develop maternal vascular malperfusion placental pathology, and these pregnancies had a 4.5 times higher risk of developing preeclampsia or delivering a SGA neonate compared with those without this pathology. A multiparameter model achieved modest precision to predict placental maternal vascular malperfusion. Importantly, in low-risk pregnancies, maternal vascular malperfusion accounts for one fourth of pregnancy outcomes with SGA or preeclampsia. The low population-attributable risk of this placental pathology for SGA and preeclampsia illustrates the importance of discovering novel associations to reduce the disease burden of these pregnancy complications.

Objective The objective of this study was to examine the association between umbilical catheters and a composite outcome of mortality or major neonatal morbidity in extremely preterm infants. Study Design Data were abstracted from the Canadian Neonatal Network database for infants born at Results Of 4,623 eligible infants, 820 (17.7%) had no catheters, 1,032 (22.3%) a UVC only, 120 (2.6%) a UAC only, and 2,651 (57.3%) had both catheters. After adjustment for acuity and other potential confounders, umbilical catheters were associated with higher odds of mortality or any major morbidity (UVC vs. no catheter: adjusted odds ratio [aOR]: 1.47; 95% CI: 1.18–1.85; UAC vs. no catheter: aOR: 1.67; 95% CI: 1.05–2.63; and both UVC + UAC vs. no catheter: aOR: 2.17; 95% CI: 1.79–2.70). Conclusion Most of the infants born at

Use, timing and doses of surfactant in preterm infants are variable in practice in modern NICUs.The objective of this study is to explore the association between use and timing of surfactant administration and common neonatal adverse outcomes in preterm infants with gestational age (GA) 28 weeks.Neonates admitted to a participating Canadian Neonatal Network NICU between 2013 and 2015 were studied. Infants were divided into three groups based on surfactant administration: none, early (within 30 min of life), and late surfactant (30 min). The primary outcome was a composite of ≥2 predefined outcomes: bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP) and severe neurological injury (intraventricular hemorrhage or intraventricular hemorrhage (IVH) grade III/IV ± periventricular leukomalacia).Of 2512 eligible neonates, 430 were in the early, and 1228 were in the late surfactant group. There was no difference in the primary outcome (p = .88). There was a slightly lower risk of late onset sepsis [25% versus 29%, adjusted odds ratio (aOR): 0.8; 95% CI: 0.6-0.9] and ROP (12.4 versus 15%, aOR: 0.7; 95% CI: 0.5-0.9) in the early surfactant group.In preterm neonates, early administration of surfactant within 30 min of life was not associated with an increased risk of the primary composite outcome, but did have decreased rates of late onset sepsis and ROP.

The objective of this study was to assess the effects of elevated luteal-phase progesterone levels (PE) and high progesterone/estradiol ratio (‘P/E2’ ratio) on IVF outcomes, exclusively in GnRH-antagonist cycles with day-5 embryo transfer. PE was not found to have a significant effect on implantation or clinical pregnancy rate (CPR) (OR 0.56, 95% CI 0.25–1.25, p = .16). Elevated ‘P/E2’ ratio (≥0.55) on trigger day was associated with a poorer response to stimulation and lower clinical pregnancy rates (OR 0.58, 95% CI 0.34–1.00, p = .05). Patients with PE and low ‘P/E2’ ratio yielded significantly more oocytes than patients with PE and high ‘P/E2’ ratio. The mean implantation rate per patient decreased by 60% in the group with PE and high ‘P/E2’ ratio in comparison to the group with PE and low ‘P/E2’ ratio (17.9%±36.6 vs. 45.5%±47.2, p = .06), although no statistical significance was observed. The detrimental effect of PE may be mitigated by culturing embryos to day-5 before embryo transfer. Combined assessment of serum progesterone and ‘P/E2’ ratio may predict pregnancy outcome better than progesterone levels alone.

Failure of first course of indomethacin (FCI) for patent ductus arteriosus (PDA) treatment in preterm neonates often prompts clinicians to consider a second course (SCI).To identify factors including baseline characteristics and response to FCI that are associated with non-response to SCI for PDA treatment in preterm neonates.In this retrospective observational study, neonates ≤32 weeks admitted to a tertiary NICU over 5 years who received two indomethacin courses for PDA treatment were reviewed. Only neonates with echocardiograms (ECHO) immediately before and after receipt of each indomethacin course were included. Primary outcome was non-response to SCI. Baseline characteristics and response to FCI were compared between responders and non-responders of SCI.Of the 98 neonates enrolled, 47 (48%) had non-response to SCI. Of them, 27 patients (57%) had prior non-response to FCI, while of the 51 neonates who responded to SCI, 24 neonates (47%) had prior non-response to FCI. The adjusted risk of non-response to SCI in patients who had non-response to FCI was 37% higher (relative risk = 1.37, 95%CI: 0.87-1.80; p = .07) compared to those who had response to FCI. Multivariable analysis showed that increasing gestational age (AOR: 1.6, 95%CI: 1.1-2.3, p = .03) was associated with a higher odds of non-response to SCI while the odds of non-response to SCI increased by 90% in patients with non-response to FCI (AOR: 1.9, 95%CI: 0.8-4.5; p = .15) compared to those with success of FCI, although no statistical significance was observed.Advanced gestational age was the predictor of non-response to SCI in preterm neonates.

Objectives To examine the association between mortality or neurodevelopmental impairment at 18-24 months of corrected age and the Transport Risk Index of Physiologic Stability (TRIPS) score on admission to the neonatal intensive care unit (NICU) in extremely premature infants. Study design Retrospective cohort study of extremely premature infants (inborn and outborn) born at 22-28 weeks of gestational age and admitted to NICUs in the Canadian Neonatal Network between April 2009 and September 2011. TRIPS scores and clinical data were collected from the Canadian Neonatal Network database. Follow-up data at 18-24 months of corrected age were retrieved from the Canadian Neonatal Follow-Up Network database. Neurodevelopment was assessed using the Bayley Scales of Infant and Toddler Development, Edition III. The primary outcome was death or significant neurodevelopmental impairment at 18-24 months of corrected age. The secondary outcomes were individual components of the Bayley Scales of Infant and Toddler Development, Edition III assessment. Results A total of 1686 eligible infants were included. A TRIPS score of ≥20 on admission to the NICU was significantly associated with mortality (aOR 2.71 [95% CI, 2.02-3.62]) and mortality or significant neurodevelopmental impairment (aOR 1.91 [95% CI, 1.52-2.41]) at 18-24 months of corrected age across all gestational age groups of extremely premature infants. Conclusion The TRIPS score on admission to the NICU can be used as an adjunctive, objective tool for counselling the parents of extremely premature infants early after their admission to the NICU.

Among men with high-risk non-metastatic castrate-resistant prostate cancer (nmCRPC), we used network meta-analysis to compare non-steroidal anti-androgens (NSAAs) and stratified class-level meta-analysis to identify subgroups with particular benefit from NSAAs with androgen deprivation therapy versus androgen deprivation therapy alone.We performed a systematic review of phase III parallel-group randomized controlled trials in adult men with nmCRPC. Primary outcome was metastasis-free survival (MFS). Secondary outcomes included overall survival (OS), prostate-specific antigen (PSA) progression-free survival (PFS), and rates of grade 3 to 4 adverse events (AEs). We assessed class-level effects using random effects models; effect modification owing to subgroup effects using random-effects models to pool study-level differences; and comparative outcomes between agents using fixed-effect network models in a Bayesian framework.Three randomized controlled trials were identified. Pooled MFS, PSA-PFS, and OS were significantly greater with NSAA versus placebo (hazard ratio [HR], 0.32; 95% confidence interval [CI], 0.25-0.41; HR, 0.08; 95% CI, 0.05-0.13; and HR, 0.74; 95% CI, 0.61-0.90, respectively). Subgroup analysis demonstrated a greater benefit with NSAAs in men with Eastern Cooperative Oncology Group performance status 0 (HR, 0.30; 95% CI, 0.24-0.38) versus 1 (HR, 0.45; 95% CI, 0.36-0.56; P = .005), but no difference owing to PSA doubling time (P = .43) or use of osteoclast targeting therapy (P = .77). Bayesian analysis showed apalutamide and enzalutamide had a 56% and 44% likelihood of maximizing MFS, respectively, with subgroup analysis demonstrating these agents were preferred regardless of PSA doubling time and performance status. There was a 44%, 41%, and 15% likelihood that apalutamide, darolutamide and enzalutamide offered the greatest OS benefit, respectively. Grade 3 to 4 AEs were more common with NSAAs (odds ratio [OR], 1.47; 95% CI, 1.27-1.71) and there was a 61% chance that darolutamide was preferred.NSAAs improve survival in high-risk nmCRPC. Apalutamide and enzalutamide may result in improved oncologic outcomes. Darolutamide may result in fewer AEs. Phase IV data are needed to validate these findings.

Importance It is unclear which umbilical cord management strategy is the best for preventing mortality and morbidities in preterm infants. Objective To systematically review and conduct a network meta-analysis comparing 4 umbilical cord management strategies for preterm infants: immediate umbilical cord clamping (ICC), delayed umbilical cord clamping (DCC), umbilical cord milking (UCM), and UCM and DCC. Data Sources PubMed, Embase, CINAHL, and Cochrane CENTRAL databases were searched from inception until September 11, 2020. Study Selection Randomized clinical trials comparing different umbilical cord management strategies for preterm infants were included. Data Extraction and Synthesis Data were extracted for bayesian random-effects meta-analysis to estimate the relative treatment effects (odds ratios [OR] and 95% credible intervals [CrI]) and surface under the cumulative ranking curve values. Main Outcomes and Measures The primary outcome was predischarge mortality. The secondary outcomes were intraventricular hemorrhage, severe intraventricular hemorrhage, need for packed red blood cell transfusion, and other neonatal morbidities. Confidence in network meta-analysis software was used to assess the quality of evidence and grade outcomes. Results Fifty-six studies enrolled 6852 preterm infants. Compared with ICC, DCC was associated with lower odds of mortality (22 trials, 3083 participants; 7.6% vs 5.0%; OR, 0.64; 95% CrI, 0.39-0.99), intraventricular hemorrhage (25 trials, 3316 participants; 17.8% vs 15.4%; OR, 0.73; 95% CrI, 0.54-0.97), and need for packed red blood cell transfusion (18 trials, 2904 participants; 46.9% vs 38.3%; OR, 0.48; 95% CrI, 0.32-0.66). Compared with ICC, UCM was associated with lower odds of intraventricular hemorrhage (10 trials, 645 participants; 22.5% vs 16.2%; OR, 0.58; 95% CrI, 0.38-0.84) and need for packed red blood cell transfusion (9 trials, 688 participants; 47.3% vs 32.3%; OR, 0.36; 95% CrI, 0.23-0.53), with no significant differences for other secondary outcomes. There was no significant difference between UCM and DCC for any outcome. Conclusions and Relevance Compared with ICC, DCC was associated with the lower odds of mortality in preterm infants. Compared with ICC, DCC and UCM were associated with reductions in intraventricular hemorrhage and need for packed red cell transfusion. There was no significant difference between UCM and DCC for any outcome. Further studies directly comparing DCC and UCM are needed.

Most studies that have compared programmed intermittent epidural bolus (PIEB) with continuous epidural infusion regimens have included patient-controlled epidural analgesia and/or manual bolus as rescue analgesia for breakthrough pain. Consequently, the optimal time interval between PIEB is yet to be determined. We designed a study to establish the optimal time interval between PIEB of 10 mL of bupivacaine 0.0625% with fentanyl 2 μg/mL to produce effective analgesia in 90% of women during first stage of labor without breakthrough pain.We conducted a double-blind sequential allocation trial with a biased-coin up-down design to obtain the effective interval 90% for the PIEB regimen. We included American Society of Anesthesiologists physical status 2-3 nulliparous women at term undergoing spontaneous or induced labor requesting epidural analgesia. An ultrasound-assisted epidural catheter placement was performed at L2/3 or L3/4. A test dose of 3 mL of bupivacaine 0.125% plus fentanyl 3.3 μg/mL was followed by a loading dose of 12 mL of the same solution. PIEB was then started in women whose pain scores achieved Verbal Numerical Rating Score ≤1/10 within 20 minutes after the end of the loading dose. In all subjects, the programmed bolus dose was fixed at 10 mL of bupivacaine 0.0625% with fentanyl 2 μg/mL. The first bolus was delivered 1 hour after the loading dose. The PIEB interval was set at 60 minutes for the first patient and at varying time intervals (60, 50, 40, and 30 minutes; groups 60, 50, 40 and 30, respectively) for the subsequent patients, according to a biased-coin design. The primary outcome was effective analgesia, defined as no requirement for a patient-controlled epidural analgesia or a manual bolus for 6 hours after the initiation of the epidural analgesia or until the patient presented with full cervical dilatation, whichever event occurred first. Pain scores, sensory block levels to ice, degree of motor block, and blood pressure were assessed hourly.We studied 40 women. The estimated effective interval 90% was 42.6 minutes (95% confidence interval 38.9-46.4) using the truncated Dixon and Mood method and 36.8 minutes (95% confidence interval 31.0-49.0) using the Isotonic Regression analysis. Almost 70% of the patients in group 30 presented with sensory block above T6, compared with 44%, 22%, and 11% in groups 40, 50, and 60, respectively. Only patients in group 30 presented with motor blockade. The incidence of hypotension was low in all groups with no treatment required.The optimal time interval between PIEB of 10 mL of bupivacaine 0.0625% with fentanyl 2 μg/mL is approximately 40 minutes. Further studies to determine the efficacy of this regimen throughout the entire duration of labor are warranted.

Objective To explore whether family integrated care (FICare) is feasible and improves the outcomes of preterm infants in China. Study design This was a multicenter prospective cluster-randomized controlled trial comparing FICare and standard care. The primary outcome was length of stay (LOS). Secondary outcomes were nosocomial infections, duration of supplemental oxygen, breastfeeding, and weight gain. Outcomes were compared using univariate and multivariable analyses adjusted for potential confounders and clustering. Results We enrolled 601 preterm infants from 11 neonatal intensive care units (FICare, n = 298; control, n = 303). The unadjusted LOS was 30.81 vs 30.26 days (mean ratio, 1.02; 95% CI, 0.85-1.22; P = .85). After adjustment, outcomes in the FICare group were improved compared with the control group, including LOS (28.26 vs 35.04 days; mean ratio, 0.81; 95% CI, 0.72-0.91), total medical expenditures (mean ratio, 0.69; 95% CI, 0.53-0.90), weight gain velocity (15.73 vs 10.30 g/day; mean difference, 5.43; 95% CI, 3.65-7.21), duration of supplemental oxygen (13.11 vs 21.42 days; mean difference, 0.71; 95% CI, 0.50-1.00), nosocomial infection rates (4.13 vs 5.84/1000 hospital days; mean ratio, 0.67; 95% CI, 0.47-0.96), antibiotic exposure (38.63 vs 57.32/100 hospital days; mean ratio, 0.67; 95% CI, 0.47-0.96), breastfeeding rates (87.25% vs 55.78%; OR, 5.42; 95% CI, 3.25-9.05), and rehospitalization rates (3.65% vs 7.48%; OR, 0.47; 95% CI, 0.28-0.77). At follow-up to 18 months, breastfeeding rates and weight were significantly (P Conclusions FICare was feasible in Chinese neonatal intensive care units and was associated with reduced hospital LOS, medical expenditures, and rates of adverse outcomes.