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Rationale: Bronchopulmonary dysplasia increases the risk of disability in extremely preterm infants. Although the pathophysiology remains uncertain, prior exposure to intermittent hypoxemia may pla...

Limited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia.We performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds until 36 weeks of postmenstrual age or discharge, whichever occurred first. The primary outcome was a composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss) at 22 to 26 months of age, corrected for prematurity.A total of 1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization. There was a between-group difference of 1.9 g per deciliter (19 g per liter) in the pretransfusion mean hemoglobin levels throughout the treatment period. Primary outcome data were available for 1692 infants (92.8%). Of 845 infants in the higher-threshold group, 423 (50.1%) died or survived with neurodevelopmental impairment, as compared with 422 of 847 infants (49.8%) in the lower-threshold group (relative risk adjusted for birth-weight stratum and center, 1.00; 95% confidence interval [CI], 0.92 to 1.10; P = 0.93). At 2 years, the higher- and lower-threshold groups had similar incidences of death (16.2% and 15.0%, respectively) and neurodevelopmental impairment (39.6% and 40.3%, respectively). At discharge from the hospital, the incidences of survival without severe complications were 28.5% and 30.9%, respectively. Serious adverse events occurred in 22.7% and 21.7%, respectively.In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity. (Funded by the National Heart, Lung, and Blood Institute and others; TOP ClinicalTrials.gov number, NCT01702805.).

Currently the question of whether to maintain a higher hemoglobin level by transfusing more liberally, as opposed to a more restrictive strategy with lower hemoglobin maintenance levels, has not been answered. We review summarized conclusions of a Cochrane systematic review and meta-analysis of 614 infants in 4 randomized controlled trials (RCT) pooling data. This suggests potential benefits of higher hemoglobin levels, i.e., a possible improved cognition of infants at 18–21 months’ corrected age and a reduction of apnea. However, the data on cognition is hypothesis generating as it derives from a post hoc analysis from a single trial in 451 infants. Moreover, the data on apnea need confirmation in larger trials. The effect of adding data of cognitive 2-year outcomes of 1,744 infants from 2 RCT, which will be reported soon, should expand our understanding. This new data will need to be integrated with the older generation of RCTs but also with emerging suggestions from observational data on potential risks of blood transfusions. We discuss some of these warnings from observational studies. Finally, we ask whether we are ready to individualize blood transfusion to physiological measures made in individual infants, and we point to some current difficulties hindering this step.

Currently the question of whether to maintain a higher hemoglobin level by transfusing more liberally, as opposed to a more restrictive strategy with lower hemoglobin maintenance levels, has not been answered. We review summarized conclusions of a Cochrane systematic review and meta-analysis of 614 infants in 4 randomized controlled trials (RCT) pooling data. This suggests potential benefits of higher hemoglobin levels, i.e., a possible improved cognition of infants at 18-21 months' corrected age and a reduction of apnea. However, the data on cognition is hypothesis generating as it derives from a post hoc analysis from a single trial in 451 infants. Moreover, the data on apnea need confirmation in larger trials. The effect of adding data of cognitive 2-year outcomes of 1,744 infants from 2 RCT, which will be reported soon, should expand our understanding. This new data will need to be integrated with the older generation of RCTs but also with emerging suggestions from observational data on potential risks of blood transfusions. We discuss some of these warnings from observational studies. Finally, we ask whether we are ready to individualize blood transfusion to physiological measures made in individual infants, and we point to some current difficulties hindering this step.

To compare the effect of umbilical cord milking (UCM) vs. early cord clamping (ECC) on cerebral blood flow (CBF). Preterm infants

The Neonatal Oxygenation Prospective Meta-analysis combined the individual participant data of 4965 extremely preterm infants. They had been randomly assigned in 5 trials to arterial oxygen saturations of 85%-89% or 91%-95% using modified oximeters to mask the treatment allocation. The primary outcome of death or disability did not differ significantly between the groups. Assignment to the higher target range reduced the risks of death and severe necrotizing enterocolitis but increased the risk of treated retinopathy. Trade-offs between the benefits and risks of higher or lower saturation targets should be informed by the local patient risks and institutional rates for outcomes that may be affected by a policy change. Features of the oximeter masking algorithm introduced unanticipated artifacts into the saturation display that are not seen in routine care. NeOProM provides little guidance on where to set the oximeter alarms and how to respond to them.

ObjectiveTo investigate whether umbilical cord milking (UCM) at birth improves systemic blood flow and short-term outcomes, as compared with immediate cord clamping (ICC).DesignRandomised clinical trial.SettingSingle tertiary care centre.PatientsInfants born to eligible women presenting in preterm labour between 24 and 31 weeks’ gestation.InterventionsUCM three times at birth or ICC.Outcome measuresPrimary outcome included systemic blood flow as represented by echo-derived superior vena cava(SVC) flow at 4–6 hours after birth. The echocardiographer and interpreter were blinded to the randomisation. Secondary outcomes included cardiac output, neonatal morbidities and mortality. Analysis was by intention to treat.ResultsA total of 73 infants were randomised (37 to UCM and 36 to ICC). Mean (SD) gestational age was 27 (2) weeks and mean (SD) birth weight was 1040 (283) g. Haemoglobin on admission was higher in the UCM than in the ICC group (16.1 vs 15.0 g/L), p=0.049 (mean difference 1.1, 95% CI 0.003 to 2.2). No statistically significant differences were found between groups in SVC flow at 4–6 hours (88.9±37.8 and 107.3±60.1 mL/kg/min), p=0.13 (mean difference −18.4, 95% CI −41.7 to 5.0 mL/kg/min) or at 10–12 hours of age (102.5±41.8 and 90.6±28.4 mL/kg/min), p=0.17 (mean difference 12.0, 95% CI −4.7 to 28.7 mL/kg/min), cardiac output or neonatal morbidities.ConclusionsCord milking was not shown to improve functional cardiac outcomes, neonatal morbidity or mortality. More research is needed before routine cord milking can be recommended for very preterm infants.Trial registrationNCT01487187.

BACKGROUND: Umbilical cord milking at birth has been reported to have short-term benefits to preterm infants. Long-term neurodevelopmental outcomes need more exploration. OBJECTIVES: To compare the effects of cord milking (CM) vs. early cord clamping (ECC) at birth on neurodevelopmental outcomes at 36 months corrected age. DESIGN/METHODS: Preterm infants

To develop a prediction model for neonatal mortality using information readily available in the antenatal period.A multiple logistic regression model of a complete population-based geographically defined cohort of very preterm infants of 23+0 to 30+6 weeks' gestation was used to identify antenatal factors which were predictive of mortality in this population. Infants lt; 23 weeks and those with major anomalies were excluded.Between 1996 and 2012, 1240 live born infants lt; 31 weeks' gestation were born to women residing in Nova Scotia. Decreasing gestational age strongly predicted an increased mortality rate. Other factors significantly contributing to increased mortality included classification as small for gestational age, oligohydramnios, maternal psychiatric disorders, antenatal antibiotic therapy, and monochorionic twins. Reduced neonatal mortality was associated with antenatal use of antihypertensive agents and use of corticosteroids of any duration of therapy given at least 24 hours before delivery. An algorithm was developed to estimate the risk of mortality without the need for a calculator.Prediction of the probability of neonatal mortality is influenced by maternal and fetal factors. An algorithm to estimate the risk of mortality facilitates counselling and informs shared decision making regarding obstetric management.

Background The use of supplemental oxygen in the care of extremely preterm infants has been common practice since the 1940s. Despite this, there is little agreement regarding which oxygen saturation (SpO) ranges to target to maximise short- or long-term growth and development, while minimising harms. There are two opposing concerns. Lower oxygen levels (targeting SpO at 90% or less) may impair neurodevelopment or result in death. Higher oxygen levels (targeting SpO greater than 90%) may increase severe retinopathy of prematurity or chronic lung disease. The use of pulse oximetry to non-invasively assess neonatal SpO levels has been widespread since the 1990s. Until recently there were no randomised controlled trials (RCTs) that had assessed whether it is better to target higher or lower oxygen saturation levels in extremely preterm infants, from birth or soon thereafter. As a result, there is significant international practice variation and uncertainty remains as to the most appropriate range to target oxygen saturation levels in preterm and low birth weight infants. Objectives 1. What are the effects of targeting lower versus higher oxygen saturation ranges on death or major neonatal and infant morbidities, or both, in extremely preterm infants? 2. Do these effects differ in different types of infants, including those born at a very early gestational age, or in those who are outborn, without antenatal corticosteroid coverage, of male sex, small for gestational age or of multiple birth, or by mode of delivery? Search methods We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 4), MEDLINE via PubMed (1966 to 11 April 2016), Embase (1980 to 11 April 2016) and CINAHL (1982 to 11 April 2016). We also searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials. Selection criteria Randomised controlled trials that enrolled babies born at less than 28 weeks' gestation, at birth or soon thereafter, and targeted SpO ranges of either 90% or below or above 90% via pulse oximetry, with the intention of maintaining such targets for at least the first two weeks of life. Data collection and analysis We used the standard methods of Cochrane Neonatal to extract data from the published reports of the included studies. We sought some additional aggregate data from the original investigators in order to align the definitions of two key outcomes. We conducted the meta-analyses with Review Manager 5 software, using the Mantel-Haenszel method for estimates of typical risk ratio (RR) and risk difference (RD) and a fixed-effect model. We assessed the included studies using the Cochrane 'Risk of bias' and GRADE criteria in order to establish the quality of the evidence. We investigated heterogeneity of effects via pre-specified subgroup and sensitivity analyses. Main results Five trials, which together enrolled 4965 infants, were eligible for inclusion. The investigators of these five trials had prospectively planned to combine their data as part of the NeOProM (Neonatal Oxygen Prospective Meta-analysis) Collaboration. We graded the quality of evidence as high for the key outcomes of death, major disability, the composite of death or major disability, and necrotising enterocolitis; and as moderate for blindness and retinopathy of prematurity requiring treatment. When an aligned definition of major disability was used, there was no significant difference in the composite primary outcome of death or major disability in extremely preterm infants when targeting a lower (SpO(2) 85% to 89%) versus a higher (SpO(2) 91% to 95%) oxygen saturation range (typical RR 1.04, 95% confidence interval (CI) 0.98 to 1.10; typical RD 0.02, 95% CI-0.01 to 0.05; 5 trials, 4754 infants) (high-quality evidence). Compared with a higher target range, a lower target range significantly increased the incidence of death at 18 to 24 months corrected age (typical RR 1.16, 95% CI 1.03 to 1.31; typical RD 0.03, 95% CI 0.01 to 0.05; 5 trials, 4873 infants) (high-quality evidence) and necrotising enterocolitis (typical RR 1.24, 95% 1.05 to 1.47; typical RD 0.02, 95% CI 0.01 to 0.04; 5 trials, 4929 infants; I-2 = 0%) (high-quality evidence). Targeting the lower range significantly decreased the incidence of retinopathy of prematurity requiring treatment (typical RR 0.72, 95% CI 0.61 to 0.85; typical RD-0.04, 95% CI-0.06 to-0.02; 5 trials, 4089 infants; I-2 = 69%) (moderate-quality evidence). There were no significant differences between the two treatment groups for major disability including blindness, severe hearing loss, cerebral palsy, or other important neonatal morbidities. A subgroup analysis of major outcomes by type of oximeter calibration software (original versus revised) found a significant difference in the treatment effect between the two software types for death (interaction P = 0.03), with a significantly larger treatment effect seen for those infants using the revised algorithm (typical RR 1.38, 95% CI 1.13 to 1.68; typical RD 0.06, 95% CI 0.01 to 0.10; 3 trials, 1716 infants). There were no other important differences in treatment effect shown by the subgroup analyses using the currently available data. Authors' conclusions In extremely preterm infants, targeting lower (85% to 89%) SpO(2) compared to higher (91% to 95%) SpO(2) had no significant effect on the composite outcome of death or major disability or on major disability alone, including blindness, but increased the average risk of mortality by 28 per 1000 infants treated. The trade-offs between the benefits and harms of the different oxygen saturation target ranges may need to be assessed within local settings (e.g. alarm limit settings, staffing, baseline outcome risks) when deciding on oxygen saturation targeting policies.

Red blood cell transfusion is an important and frequent component of neonatal intensive care. The present position statement addresses the methods and indications for red blood cell transfusion of the newborn, based on a review of the current literature. The most frequent indications for blood transfusion in the newborn are the acute treatment of perinatal hemorrhagic shock and the recurrent correction of anemia of prematurity. Perinatal hemorrhagic shock requires immediate treatment with large quantities of red blood cells; the effects of massive transfusion on other blood components must be considered. Some guidelines are now available from clinical trials investigating transfusion in anemia of prematurity; however, considerable uncertainty remains. There is weak evidence that cognitive impairment may be more severe at follow-up in extremely low birth weight infants transfused at lower hemoglobin thresholds; therefore, these thresholds should be maintained by transfusion therapy. Although the risks of transfusion have declined considerably in recent years, they can be minimized further by carefully restricting neonatal blood sampling.La transfusion de culot globulaire est un élément important et fréquent des soins intensifs néonatals. Le présent document de principes traite des méthodes et des indications pour transfuser des culots globulaires au nouveau-né, d’après une analyse bibliographique. Les principales indications de transfusion sanguine au nouveau-né sont le traitement aigu du choc hémorragique périnatal et la correction récurrente de l’anémie de la prématurité. Le choc hémorragique périnatal exige l’administration immédiate de fortes quantités de culots globulaires, mais il faut tenir compte des effets d’une transfusion massive sur d’autres composants sanguins. Grâce à des essais cliniques sur les transfusions en cas d’anémie de la prématurité, il est désormais possible de compter sur des lignes directrices, même s’il reste beaucoup d’incertitude. D’après des données dont la qualité de preuves est faible, l’atteinte cognitive pourrait être plus grave au suivi chez les nouveau-nés d’extrême petit poids à la naissance qui sont transfusés à des seuils d’hémoglobine bas. Il faut donc maintenir ces seuils par thérapie transfusionnelle. Même si les risques de transfusion ont diminué considérablement ces dernières années, on peut les réduire encore davantage en limitant soigneusement les ponctions capillaires néonatales.

Importance There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen. Objective To compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity. Design, Setting, and Participants Prospectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks’ gestation. Exposures Spo2 target range that was lower (85%-89%) vs higher (91%-95%). Main Outcomes and Measures The primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score Results A total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, −1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2 target group (risk difference, −4.0% [95% CI, −6.1% to −2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P Conclusions and Relevance In this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.

The side-lying position is one of several options offered to women in the postpartum period to assist with early establishment of breastfeeding. Many new mothers are exhausted and experiencing significant pain following birth. While the side-lying position for breastfeeding can allow women to get needed rest, it can increase their risk of falling asleep while in this position and potentially smothering their babies. We report two cases of apparent suffocation in newborns on the maternity ward when women unintentionally fell asleep while breastfeeding in the side-lying position. Interventions that may help to prevent such events are suggested.

It has been reported in the 3 Benefits of Oxygen Saturation Targeting (BOOST-II) trials that changes in oximeter calibration software resulted in clearer separation between the oxygen saturations in the two trial target groups. A revised analysis of the published BOOST-II data does not support this conclusion.

Subgroup analysis of the Canadian Oxygen Trial to compare outcomes of extremely preterm infants in centers with more versus less separation between median arterial oxygen saturations in the two target ranges . Centers with more separation observed lower rates of death or disability in the 85%-89% range than in the 91%-95% target range.

Late and moderate preterm infants form the majority of admissions for prematurity to special care neonatal nurseries. Although at risk for acute disorders of prematurity, they do not suffer the serious long term risks and chronic illnesses of the extremely premature. The special challenges addressed here are of transition and of thermal adaptation, nutritional compensation for postnatal growth restriction, the establishment of early feeding, and the avoidance of post-discharge jaundice or apnea. These 'healthy' premature infants provide challenges for discharge planning, in that opportunities may be available for discharge well before the expected date of delivery, which should be pursued. Barriers to early discharge are rigid conservative protocols and unwarranted investigations; facilitators of discharge are individualized care by nurses expert in cue-based feeding, early management of the thermal environment, support of family preferences and encouragement of mother-baby interactions. Safe discharge depends on recognizing these opportunities and applying strategies to address them.

Resume Les nourrissons peu prematures sont des nourrissons prematures, mais souvent assez matures pour etre pris en charge dans des milieux et a l’aide de regimes therapeutiques concus pour les nouveau-nes a terme. On les definit arbitrairement comme des nourrissons nes a 34, 35 ou 36 semaines d’âge gestationnel. Les nourrissons peu prematures ont plus de problemes d’adaptation que les nourrissons a terme et peuvent avoir besoin de soins intensifs neonatals et d’une hospitalisation prolongee. Cependant, ceux qui n’en ont pas besoin peuvent, de maniere tout a fait pertinente, etre envoyes en soins mereenfant dans une pouponniere a faible risque. Chez le nourrisson peu premature, il faut accorder une attention particuliere a l’homeostasie thermique pertinente et a la mise en place d’une alimentation satisfaisante avant le conge. Notamment, il faut s’assurer que ces bebes ne font pas d’hyperbilirubinemie tardive grave, qui se produit habituellement chez le bebe peu premature allaite de quatre ou cinq jours de vie et qui n’est pas toujours previsible par le depistage systematique de la bilirubine avant 48 heures de vie. Le conge d’un nourrisson peu premature s’associe a des exigences particulieres dans la collectivite. L’etablissement qui accorde le conge doit prevoir des installations accessibles pour reprendre des tests de depistage, proceder a une reevaluation et une rehospitalisation.

BACKGROUND AND OBJECTIVE. Extremely low birth weight infants frequently receive red cell transfusions. We sought to determine whether a restrictive versus liberal hemoglobin transfusion threshold results in differences in death or adverse neurodevelopmental outcomes of extremely low birth weight infants. PATIENTS AND METHODS. Extremely low birth weight infants previously enrolled in the Preterm Infants in Need of Transfusion Trial, a randomized, controlled trial of low versus high hemoglobin transfusion thresholds, were followed up at 18 to 21 months’ corrected age. Erythrocyte transfusion was determined by an algorithm of low (restrictive) or high (liberal) hemoglobin transfusion thresholds, differing by 10 to 20 g/L and maintained until first hospital discharge. The primary composite outcome was death or the presence of cerebral palsy, cognitive delay, or severe visual or hearing impairment. RESULTS. Of 451 enrolled infants, the primary outcome was available in 430. There was no statistically significant difference in the primary outcome, found in 94 (45%) of 208 in the restrictive group and 82 (38%) of 213 in the liberal group. There were no statistically significant differences in preplanned secondary outcomes. However, the difference in cognitive delay (Mental Development Index score < 70) approached statistical significance. A posthoc analysis with cognitive delay redefined (Mental Development Index score < 85) showed a significant difference favoring the liberal threshold group. CONCLUSIONS. Maintaining the hemoglobin of extremely low birth weight infants at these restrictive rather than liberal transfusion thresholds did not result in a statistically significant difference in combined death or severe adverse neurodevelopmental outcome.

Background: Co-bedding, a developmental care practice for twins and multiples, has been theorized as a strategy to decrease the adverse neurodevelopmental effects that may be associated with hospitalization. Objective: The aim of this study was to determine the feasibility of study design, methods, and the measurement of desired outcomes for the development of a larger multicentered study. Results: Study findings were used to estimate effect size, determine staff and bedside care organization, evaluate feasibility of data collection measures, and identify issues related to recruitment and follow-up. Results were incorporated in the development of a larger multicentered trial grant proposal. Discussion: Pilot studies can play an important role in the development of a competitive grant proposal and efficient conduct of a research trial. Pilot studies strengthen a proposal by providing essential baseline information. A general overview of the purpose of pilot studies is provided here, along with a description of the process of using findings from a pilot study to inform the development of a larger multisite trial. Findings from this pilot study examining the effects of co-bedding on twins and their parents are used to revise the research protocol for a larger multisite trial. These changes, which lead to improvement to the protocol, and the rational for these changes are highlighted.

Extremely preterm infants may experience intermittent hypoxemia or bradycardia for many weeks after birth. The prognosis of these events is uncertain.To determine the association between intermittent hypoxemia or bradycardia and late death or disability.Post hoc analysis of data from the inception cohort assembled for the Canadian Oxygen Trial in 25 hospitals in Canada, the United States, Argentina, Finland, Germany, and Israel, including 1019 infants with gestational ages of 23 weeks 0 days through 27 weeks 6 days who were born between December 2006 and August 2010 and survived to a postmenstrual age of 36 weeks. Follow-up assessments occurred between October 2008 and August 2012.Episodes of hypoxemia (pulse oximeter oxygen saturation80%) or bradycardia (pulse rate80/min) for 10 seconds or longer. Values were sampled every 10 seconds within 24 hours after birth until at least 36 weeks' postmenstrual age.The primary outcome was a composite of death after 36 weeks' postmenstrual age, motor impairment, cognitive or language delay, severe hearing loss, or bilateral blindness at 18 months' corrected age. Secondary outcomes were motor impairment, cognitive or language delay, and severe retinopathy of prematurity.Downloaded saturation and pulse rate data were available for a median of 68.3 days (interquartile range, 56.8-86.0 days). Mean percentages of recorded time with hypoxemia for the least and most affected 10% of infants were 0.4% and 13.5%, respectively. Corresponding values for bradycardia were 0.1% and 0.3%. The primary outcome was ascertained for 972 infants and present in 414 (42.6%). Hypoxemic episodes were associated with an estimated increased risk of late death or disability at 18 months of 56.5% in the highest decile of hypoxemic exposure vs 36.9% in the lowest decile (modeled relative risk, 1.53; 95% CI, 1.21-1.94). This association was significant only for prolonged hypoxemic episodes lasting at least 1 minute (relative risk, 1.66; 95% CI, 1.35-2.05 vs for shorter episodes, relative risk, 1.01; 95% CI, 0.77-1.32). Relative risks for all secondary outcomes were similarly increased after prolonged hypoxemia. Bradycardia did not alter the prognostic value of hypoxemia.Among extremely preterm infants who survived to 36 weeks' postmenstrual age, prolonged hypoxemic episodes during the first 2 to 3 months after birth were associated with adverse 18-month outcomes. If confirmed in future studies, further research on the prevention of such episodes is needed.

To evaluate the efficacy of cobedding on twin coregulation and twin safety.Randomized controlled trial (RCT).Two university affiliated Level III neonatal intensive care units (NICUs).One hundred and seventeen sets (N = 234) of stable preterm twins (37 weeks gestational age at birth) admitted to the NICU.Sets of twins were randomly assigned to be cared for in a single cot (cobedded) or in separate cots (standard care). State response was obtained from videotaped and physiologic data measured and recorded for three, 3-hour sessions over a one-week study period. Tapes were coded for infant state by an assessor blind to the purpose of the study.Twins who were cobedded spent more time in the same state (p.01), less time in opposite states (p.01), were more often in quiet sleep (p.01) and cried less (p.01) than twins who were cared for in separate cots. There was no difference in physiological parameters between groups (p = .85). There was no difference in patient safety between groups (incidence of sepsis, p = .95), incidence of caregiver error (p = .31), and incidence of apnea (p = .70).Cobedding promotes self-regulation and sleep and decreases crying without apparent increased risk.

Many therapies in neonatology persist without supportive evidence: some common therapies may actually be harmful. Evidence-based medicine is the "conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients". The best available evidence, however, is not always sound or valid evidence. Sometimes, when faced with a collection of reports that do not constitute good evidence, attempts to choose the best evidence become pointless; in this case, a statement of no good evidence is preferable. There is a continuing problem with the place of usual practice in the hierarchy of evidence; usual practice generates experience with a particular practice but no reliable information regarding how the practice compares with alternative strategies. Although clinical and institutional inertia combined with a litigious practice environment tend to uphold current practice, the field of neonatology is ripe with examples of established therapies that were subsequently shown to be harmful. It is important to focus on important long-term outcomes and as much on the possibility of harm as on the chance of benefit, especially for new therapies, before they become routine practice. In the face of inadequate evidence, it is particularly important to avoid the temptation to institute treatment guidelines that inhibit further research. Patients are better served by guidelines that recommend only strategies that are supported by strong evidence and recommend further research when the evidence is inadequate.

OBJECTIVE. To compare cost-effectiveness of three types of infant transport models (Emergency Medical Technicians [EMT], Registered Nurses [RN], or Combined Teams [CT] of RNs and Respiratory Therapists) and to derive a decision model to guide choice of a transport system. RESEARCH DESIGN. A prospective, multi-center, observational study was conducted to compare infant physiologic status before and after transport. Cost-effectiveness analysis from the perspective of the third-party payer, sensitivity analysis and threshold analysis were performed. SUBJECTS. All (n = 1931) out born infants with complete transport data admitted to 11 regional tertiary-level Canadian NICUs from January 1996 to October 1997. MEASURES. Change in Transport Risk Index of Physiologic Stability (TRIPS) Score before and after transport, transport costs. RESULTS. Change in TRIPS was predicted by gestational age at transport, transport duration, and pretransport TRIPS score, but not the type (EMT, RN, CT) of transport team, mode (air/ground) or direction (forward/retrograde) of transport, presence of a physician, and other baseline population risks (sex, small for gestational age, antenatal corticosteroid treatment, Apgar score). The RN model is least costly under most assumptions. At high transport volumes (>2760 transports per year) and long average transport times (>6.8 h per transport), the EMT model was less costly. Cost drivers of transport were volume of transport, relative wages of transport personnel, and percent of waiting time dedicated to infant transport. CONCLUSIONS. A deterministic decision-analytic model can be used to model transport cost-effectiveness and derive a thresold analytic chart for identifying the lest costyl transport model.

To compare pulse oximetry measurement bias between infants with hypoxemia with either dark skin or light skin with Masimo Radical 7 and Nellcor Oximax. There was no significant difference in systematic bias based on skin pigment for either oximeter.

Les soins intensifs neonatals, notamment chez les nouveau-nes de tres petit poids a la naissance, se caracterisent par de frequentes transfusions de culots globulaires (CG). Le present document de principes, qui remplace celui que la Societe canadienne de pediatrie a publie en 2002,(1) vise a fournir des recommandations fondees sur des donnees probantes a l’egard des transfusions de CG aux nouveau-nes. Depuis 2002, les objectifs de reduction securitaire de l’exposition aux transfusions tout en evitant les consequences aigues et chroniques de la depletion de globules rouges ont ete influences par les resultats d’essais cliniques detailles(2–5) et une analyse Cochrane.(6) Les indications relatives a l’exsanguinotransfusion ne sont pas abordees dans le present document. Les transfusions sanguines chez le nouveau-ne sont surtout indiquees pour le traitement aigu du choc hemorragique perinatal ou chirurgical et pour « maintenir» la correction recurrente de l’anemie du premature. L’environnement et la culture lies aux transfusions sanguines ont beaucoup change depuis l’emergence du VIH-sida. Les progres de la medecine transfusionnelle, qui assurent une reduction de l’exposition a de multiples donneurs et des risques que posent les donneurs, ont accru la confiance envers les banques de sang.(7–9) Les auteurs ont examine les documents scientifiques sur le sujet, publies entre 1976 et 2012 et tires de MEDLINE, de la Cochrane Database of Systematic Reviews et du Cochrane Controlled Trials Register. Ils ont utilise les series d’algorithmes cliniques de PubMed pour le traitement, le diagnostic et le pronostic, au besoin, afin d’explorer chaque enonce dote d’une qualite de preuves. Pour ce qui est des recommandations therapeutiques, ils ont favorise les analyses Cochrane, qu’ils ont mises a jour au besoin.

Objective: Previous studies that compared outcomes of infants born outside tertiary care centers (outborn) with those born in tertiary care centers (inborn) did not account for admission illness severity and perinatal risks. The objective of this study was to examine whether outborn status is associated with higher mortality and morbidity, after adjustment for perinatal risks and admission illness severity (using the Score for Neonatal Acute Physiology, Version II [SNAP-II]) among preterm infants who were admitted to Neonatal Intensive Care Units (NICUs). Methods: Logistic regression analysis was used to compare the risk-adjusted outcomes of 3769 singleton infants born at or before 32 weeks’ gestation, who were admitted to 17 Canadian NICUs during 1996–1997. Results: Outborn and inborn infants had significantly different gestational ages, perinatal risk factors (maternal hypertension, prenatal care, antenatal corticosteroid therapy, 5-minute Apgar score, delivery type, small for gestational age) and admission SNAP-II. Outborn infants were at higher risk of death (adjusted odds ratio [OR] 1.7, 95% confidence interval [CI] 1.2, 2.5), grade III or IV intraventricular hemorrhage (adjusted OR 2.2, 95% CI 1.5, 3.2), patent ductus arteriosus (adjusted OR 1.6, 95% CI 1.2, 2.1), respiratory distress syndrome (adjusted OR 4.8, 95% CI 3.6, 6.3), and nosocomial infection (adjusted OR 2.5, 95% CI 1.9, 3.3), even after adjusting for perinatal risks and admission illness severity. Conclusions: Outborn infants were less mature and more ill than inborn infants at NICU admission. However, even after adjustment for perinatal risks and admission illness severity, inborn infants had better outcomes than outborn infants. Our results support in-utero transfer of high-risk pregnancies to a tertiary level facility.

Objectives: To develop and validate a practical, physiology-based system for assessment of infant transport care. Study design: Transport teams prospectively collected data, before and after transport, from 1723 infants at 8 neonatal intensive care units (NICUs) from 1996 to 1997. We used logistic regression to derive a prediction model for mortality within 7 days of NICU admission and develop the Transport Risk Index of Physiologic Stability (TRIPS). We validated TRIPS for prediction of 7-day mortality, total NICU mortality (until discharge), and severe (≥grade 3) intraventricular hemorrhage. Results: TRIPS comprises 4 empirically weighted items (temperature, blood pressure, respiratory status, and response to noxious stimuli). TRIPS discriminated 7-day NICU mortality and total NICU mortality from survival with receiver operating characteristic areas of 0.83 and 0.76, respectively. There was good calibration across the full range of TRIPS scores and gestational age groups. Increase and decrease in TRIPS scores after transport were associated with increased and decreased mortality, respectively. The receiver operating characteristic area for TRIPS prediction of severe intraventricular hemorrhage was 0.74. Addition of TRIPS improved performance of prediction models in which gestational age and baseline population risk variables were used. Conclusions: TRIPS is validated for infant transport assessment. (J Pediatr 2001;139:220-6)

Importance The goal of oxygen therapy is to deliver sufficient oxygen to the tissues while minimizing oxygen toxicity and oxidative stress. It remains uncertain what values of arterial oxygen saturations achieve this balance in preterm infants. Objective To compare the effects of targeting lower or higher arterial oxygen saturations on the rate of death or disability in extremely preterm infants. Design, Setting, and Participants Randomized, double-blind trial in 25 hospitals in Canada, the United States, Argentina, Finland, Germany, and Israel in which 1201 infants with gestational ages of 23 weeks 0 days through 27 weeks 6 days were enrolled within 24 hours after birth between December 2006 and August 2010. Follow-up assessments began in October 2008 and ended in August 2012. Interventions Study participants were monitored until postmenstrual ages of 36 to 40 weeks with pulse oximeters that displayed saturations of either 3% above or below the true values. Caregivers adjusted the concentration of oxygen to achieve saturations between 88% and 92%, which produced 2 treatment groups with true target saturations of 85% to 89% (n = 602) or 91% to 95% (n = 599). Alarms were triggered when displayed saturations decreased to 86% or increased to 94%. Main Outcomes and Measures The primary outcome was a composite of death, gross motor disability, cognitive or language delay, severe hearing loss, or bilateral blindness at a corrected age of 18 months. Secondary outcomes included retinopathy of prematurity and brain injury. Results Of the 578 infants with adequate data for the primary outcome who were assigned to the lower target range, 298 (51.6%) died or survived with disability compared with 283 of the 569 infants (49.7%) assigned to the higher target range (odds ratio adjusted for center, 1.08; 95% CI, 0.85 to 1.37; P = .52). The rates of death were 16.6% for those in the 85% to 89% group and 15.3% for those in the 91% to 95% group (adjusted odds ratio, 1.11; 95% CI, 0.80 to 1.54; P = .54). Targeting lower saturations reduced the postmenstrual age at last use of oxygen therapy (adjusted mean difference, −0.8 weeks; 95% CI, −1.5 to −0.1; P = .03) but did not alter any other outcomes. Conclusion and Relevance In extremely preterm infants, targeting oxygen saturations of 85% to 89% compared with 91% to 95% had no significant effect on the rate of death or disability at 18 months. These results may help determine the optimal target oxygen saturation. Trial Registrations ISRCTN Identifier: 62491227; ClinicalTrials.gov Identifier: NCT00637169JAMA. 2013;309(20):2111-2120

Objective: To investigate the effects on oxygenation of targeting the higher versus the lower end of the currently recommended range for pulse oximetry (Sp o 2 ). Design: Nonrandomized crossover trial with the use of within-subject comparisons (two-tailed paired t test). Setting: Level III neonatal intensive care unit of a university hospital. Patients: Twenty infants whose lungs were mechanically ventilated (mean ± SD: birth weight, 1192 ± 396 gm; gestational age, 28.7 ± 2.7 weeks; age at time of study, 42 ± 26 hours). Interventions: The inspired oxygen concentration was adjusted to achieve Sp o 2 readings of 93% to 96% versus 89% to 92% (Ohmeda pulse oximeter) or 95% to 98% versus 91% to 94% (Nellcor oximeter). Measurements: Cardiac output was measured by echocardiography, oxygen content of arterial blood samples by cooximetry, and oxygen consumption by indirect calorimetry. Results: The inspired oxygen concentrations required to achieve the Sp o 2 target ranges were 39.8% ± 8.3% versus 28.7% ± 6.1% ( p

Our objective was to survey neonatologists regarding international practice of red cell transfusion thresholds for premature infants with

Surviving extremely low-birth-weight infants are at risk of severe neurodevelopmental disability. Transfusion with packed red cells is almost universal in the care of these infants, but the hemoglobin threshold at which these transfusions should be given is unclear. Different clinical trials of restrictive (low hemoglobin) versus liberal (high hemoglobin) thresholds have addressed either neurodevelopmental outcomes at 18-21 months of corrected gestational age or psychological tests and brain imaging at 8-15 years of age. Early follow-up shows differences in cognitive outcome favoring the liberal strategy, but as a post hoc secondary outcome. The childhood studies favor the restrictive strategy, but include major methodological problems of secondary recruitment. No firm conclusion can be reached, other than to report that serious adverse effects may be attributable to one or other of these strategies, that prudent practice is to remain within trial protocols, and that further redesigned clinical trials are required.

Objective To establish the evidence of therapeutic hypothermia for newborns with hypoxic ischemic encephalopathy (HIE). Data Sources Cochrane Central Register of Controlled Trials, Oxford Database of Perinatal Trials, MEDLINE, EMBASE, and previous reviews. Study Selection Randomized controlled trials that compared therapeutic hypothermia to normothermia for newborns with HIE. Intervention Therapeutic hypothermia. Main Outcome Measures Death or major neurodevelopmental disability at 18 months. Results Seven trials including 1214 newborns were identified. Therapeutic hypothermia resulted in a reduction in the risk of death or major neurodevelopmental disability (risk ratio [RR], 0.76; 95% CI, 0.69-0.84) and increase in the rate of survival with normal neurological function (1.63; 1.36-1.95) at age 18 months. Hypothermia reduced the risk of death or major neurodevelopmental disability at age 18 months in newborns with moderate HIE (RR, 0.67; 95% CI, 0.56-0.81) and in newborns with severe HIE (0.83; 0.74-0.92). Both total body cooling and selective head cooling resulted in reduction in the risk of death or major neurodevelopmental disability (RR, 0.75; 95% CI, 0.66-0.85 and 0.77; 0.65-0.93, respectively). Conclusion Hypothermia improves survival and neurodevelopment in newborns with moderate to severe HIE. Total body cooling and selective head cooling are effective methods in treating newborns with HIE. Clinicians should consider offering therapeutic hypothermia as part of routine clinical care to these newborns.

Background Infants of very low birth weight often receive multiple transfusions of red blood cells, usually in response to predetermined haemoglobin or haematocrit thresholds. In the absence of better indices, haemoglobin levels are imperfect but necessary guides to the need for transfusion. Chronic anaemia in premature infants may, if severe, cause apnoea, poor neurodevelopmental outcomes or poor weight gain. On the other hand, red blood cell transfusion may result in transmission of infections, circulatory or iron overload, or dysfunctional oxygen carriage and delivery. Objectives To determine if erythrocyte transfusion administered to maintain low as compared to high haemoglobin thresholds reduces mortality or morbidity in very low birth weight infants enrolled within three days of birth. Search methods Two review authors independently searched the Cochrane Central Register of Controlled Trials (The Cochrane Library) , MEDLINE, EMBASE, and conference proceedings through June 2010. Selection criteria We selected randomised controlled trials (RCTs) comparing the effects of early versus late, or restrictive versus liberal erythrocyte transfusion regimes in low birth weight infants applied within three days of birth, with mortality or major morbidity as outcomes. Data collection and analysis Two review authors independently selected the trials. Main results Four trials, enrolling a total of 614 infants, compared low (restrictive) to high (liberal) haemoglobin thresholds. Restrictive thresholds tended to be similar, but one trial used liberal thresholds much higher than the other three. There were no statistically significant differences in the combined outcomes of death or serious morbidity at first hospital discharge (typical risk ratio (RR) 1.19; 95% confidence interval (CI) 0.95 to 1.49) or in component outcomes. Only the largest trial reported follow-up at 18 to 21 months corrected gestational age; in this study there was no statistically significant difference in a composite of death or adverse neurodevelopmental outcome (RR 1.06; 95% CI 0.95 to 1.19). One additional trial comparing transfusion for clinical signs of anaemia versus transfusion at a set level of haemoglobin or haematocrit, reported no deaths and did not address disability. Authors' conclusions The use of restrictive as compared to liberal haemoglobin thresholds in infants of very low birth weight results in modest reductions in exposure to transfusion and in haemoglobin levels. Restrictive practice does not appear to have a significant impact on death or major morbidities at first hospital discharge or at follow-up. However, given the uncertainties of these conclusions, it would be prudent to avoid haemoglobin levels below the lower limits tested here. Further trials are required to clarify the impact of transfusion practice on long term outcome.

The Premature Infants in Need of Transfusion (PINT) Outcome Study showed no significant difference in the primary outcome of death or neurodevelopmental impairment (NDI) in extremely low birthweight (ELBW) infants. However, a post-hoc analysis expanding the definition of NDI to include borderline intellectual functioning (Mental Development Index (MDI)85) found an improvement in outcomes in the group maintained at higher haemoglobin levels.To determine the cost effectiveness of more frequent red blood cell transfusions (high-Hb threshold) compared with less frequent transfusions (low-Hb threshold) in ELBW infants.The authors performed an economic evaluation using patient-level data collected during the PINT randomised trial. The authors measured comprehensive costs from a third-party payer's perspective over a time horizon from birth through 18-21 months corrected age.The average total cost in the high-Hb threshold group was CAN$149 767 compared with CAN$150 227 in the low-Hb threshold group (difference of CAN$460, p=0.96). Cost-effectiveness analysis estimated savings of CAN$6879 for every additional infant surviving without severe NDI. There was a 48% chance that the high-Hb threshold reduced costs while improving outcome and a 90% chance that it would be cost effective at a willingness-to-pay threshold of CAN$250 000 per additional survivor without severe NDI. Post-hoc analysis defining cognitive delay as MDI score85, instead of70, revealed savings in the high-Hb threshold group of CAN$4457 per additional survivor without NDI. Results were robust to deterministic sensitivity analyses.A high-Hb threshold for transfusion, as measured in ELBW PINT study infants through 18 months corrected gestational age, may be an economically appealing intervention. The estimates were associated with moderate statistical uncertainty that should be targeted in larger, future studies.

To test the hypotheses that administering dopamine before and concurrently with indomethacin therapy would (1) increase successful ductal closure rate, (2) act by maintaining a diuresis, and (3) prevent oliguria or high serum creatinine concentrations, we conducted a randomized, controlled trial in infants whose gestational age was36 weeks and who had hemodynamically significant ductus arteriosus. Thirty-six infants were selected to receive a continuous infusion of either placebo or dopamine at either a low dosage of 2 micrograms/kg per minute or a higher dosage of 5 micrograms/kg per minute, beginning 6 hours before the use of indomethacin and continuing until 12 hours after the third dose of indomethacin. A total of 12 patients were selected to receive placebo, 14 were selected to receive "low dopamine," and 10 were selected to receive "high dopamine." The three groups were similar in their initial characteristics. Serum creatinine concentrations, urine output, and fractional excretion of sodium were not different in the three groups after indomethacin treatment. Two patients receiving placebo required a second course of indomethacin compared with four patients in the low-dopamine group and one in the high-dopamine group. The proportion of failures of medical treatment was not statistically different among the three groups. We conclude that concomitant dopamine therapy neither decreases the failure rate in indomethacin-treated infants nor reduces the magnitude of the indomethacin-induced oliguria.

Background: We developed and tested a new method, called the Evidence-based Practice for Improving Quality method, for continuous quality improvement. Methods: We used cluster randomization to assign 6 neonatal intensive care units (ICUs) to reduce nosocomial infection (infection group) and 6 ICUs to reduce bronchopulmonary dysplasia (pulmonary group). We included all infants born at 32 or fewer weeks gestation. We collected baseline data for 1 year. Practice change interventions were implemented using rapid-change cycles for 2 years. Results: The difference in incidence trends (slopes of trend lines) between the ICUs in the infection and pulmonary groups was − 0.0020 (95% confidence interval [CI] − 0.0007 to 0.0004) for nosocomial infection and − 0.0006 (95% CI − 0.0011 to − 0.0001) for bronchopulmonary dysplasia. Interpretation: The results suggest that the Evidence-based Practice for Improving Quality method reduced bronchopulmonary dysplasia in the neonatal ICU and that it may reduce nosocomial infection.

To determine whether extremely low birth weight infants (ELBW) transfused at lower hemoglobin thresholds versus higher thresholds have different rates of survival or morbidity at discharge.Infants weighing1000 g birth weight were randomly assigned within 48 hours of birth to a transfusion algorithm of either low or high hemoglobin transfusion thresholds. The composite primary outcome was death before home discharge or survival with any of either severe retinopathy, bronchopulmonary dysplasia, or brain injury on cranial ultrasound. Morbidity outcomes were assessed, blinded to allocation.Four hundred fifty-one infants were randomly assigned to low (n = 223) or high (n = 228) hemoglobin thresholds. Groups were similar, with mean birth weight of 770 g and gestational age of 26 weeks. Fewer infants received one or more transfusions in the low threshold group (89% low versus 95% high, P = .037). Rates of the primary outcome were 74.0% in the low threshold group and 69.7% in the high (P = .25; risk difference, 2.7%; 95% CI -3.7% to 9.2%). There were no statistically significant differences between groups in any secondary outcome.In extremely low birth weight infants, maintaining a higher hemoglobin level results in more infants receiving transfusions but confers little evidence of benefit.

Many therapies in neonatology persist without supportive evidence: some common therapies may actually be harmful. Evidence-based medicine is the "conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients". The best available evidence, however, is not always sound or valid evidence. Sometimes, when faced with a collection of reports that do not constitute good evidence, attempts to choose the best evidence become pointless; in this case, a statement of no good evidence is preferable. There is a continuing problem with the place of usual practice in the hierarchy of evidence; usual practice generates experience with a particular practice but no reliable information regarding how the practice compares with alternative strategies. Although clinical and institutional inertia combined with a litigious practice environment tend to uphold current practice, the field of neonatology is ripe with examples of established therapies that were subsequently shown to be harmful. It is important to focus on important long-term outcomes and as much on the possibility of harm as on the chance of benefit, especially for new therapies, before they become routine practice. In the face of inadequate evidence, it is particularly important to avoid the temptation to institute treatment guidelines that inhibit further research. Patients are better served by guidelines that recommend only strategies that are supported by strong evidence and recommend further research when the evidence is inadequate.

To determine whether the Score for Neonatal Acute Physiology, Version II (SNAP-II), improved prediction of severe (or = grade III) intraventricular hemorrhage (IVH) and chronic lung disease (CLD) when compared to models using gestational age (GA) and traditional risk factors (e.g., Apgar score, small-for-gestational-age, sex, outborn status).We examined 4226 infantsor = 32 weeks' GA admitted to 17 Canadian neonatal intensive care units between 1996 and 1997. We compared prediction models for severe IVH and CLD, with and without SNAP-II.SNAP-II was a significant and independent predictor of severe IVH and CLD. Addition of SNAP-II to models using GA and traditional risk variables significantly (p0.05) improved model prediction (AUC 0.8 for severe IVH; 0.83 for CLD). Models were well calibrated (p0.05 for Hosmer-Lemeshow goodness of fit test).Addition of SNAP-II to models using GA and traditional risk factors significantly improves prediction of severe IVH and CLD.

Objective To compare oxygen saturations as displayed to caregivers on offset pulse oximeters in the 2 groups of the Canadian Oxygen Trial. Study design In 5 double-blind randomized trials of oxygen saturation targeting, displayed saturations between 88% and 92% were offset by 3% above or below the true values but returned to true values below 84% and above 96%. During the transition, displayed values remained static at 96% in the lower and at 84% in the higher target group during a 3% change in true saturations. In contrast, displayed values changed rapidly from 88% to 84% in the lower and from 92% to 96% in the higher target group during a 1% change in true saturations. We plotted the distributions of median displayed saturations on days with >12 hours of supplemental oxygen in 1075 Canadian Oxygen Trial participants to reconstruct what caregivers observed at the bedside. Results The oximeter masking algorithm was associated with an increase in both stability and instability of displayed saturations that occurred during the transition between offset and true displayed values at opposite ends of the 2 target ranges. Caregivers maintained saturations at lower displayed values in the higher than in the lower target group. This differential management reduced the separation between the median true saturations in the 2 groups by approximately 3.5%. Conclusions The design of the oximeter masking algorithm may have contributed to the smaller-than-expected separation between true saturations in the 2 study groups of recent saturation targeting trials in extremely preterm infants.

Background.Previous reports of variations in outcomes among neonatal intensive care units (NICUs) examined only specific subpopulations of interest (eg, very low birth weight [VLBW] infants Objectives.We report on current practice and outcomes variations in a population-based national study of Canadian NICUs from January 8, 1996 to October 31, 1997.Method.Information on 20 488 admissions to 17 tertiary level NICUs across Canada was prospectively collected by trained abstractors using a standard manual of operations and definitions. Data were verified and analyzed in concert with a steering committee comprising experienced researchers and neonatologists. Patient information included demographic information, antenatal history, mode of delivery, problems at delivery, status of infant and problems at birth, illness severity (Clinical Risk Index for Babies, Score for Neonatal Acute Physiology, Score for Neonatal Acute Physiology-Version II), therapeutic intensity (Neonatal Therapeutic Intensity Scoring System [NTISS]), selected NICU practices and procedures, use of technology and resources, and selected patient outcomes. Patients were tracked until death or discharge home.Results.The mean number of annual admissions to an NICU was 657, with 26% outborn infants. Fifty-three percent were Conclusion.This study provides population-based information about NICU outcomes. Significant variation in NICU practices and outcomes was observed despite Canada's universal health insurance system. This national database provides valuable information for planning research, allocating resources, designing health and public policy, and serving as a basis for longitudinal studies of NICU care in Canada.

Background: Infants of extremely low-birth-weight (ELBW, or