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Purpose: There is a lack of studies describing reproductive health service use and outcomes with telehealth in publicly funded clinics in community settings for economically disadvantaged adolescents and young adults (AYA). This study sought to compare use of reproductive health services before and during the COVID-19 pandemic and analyze the types and quality of reproductive health-care services for patients who did and did not complete a telehealth visit., Methods: Medical records were reviewed for AYA who sought reproductive health services at 9 urban family planning and school-based clinics. Visit-type differences and associated factors by year of service and among those who did and did not complete telehealth visits were analyzed., Results: Twenty-seven thousand nine hundred sixty-one unique patients were served between 2019 and 2021. As compared to 2019, in 2020 and 2021, there were significantly fewer visits by minors (<18 years old) versus young adults (18-24 years old) (p < .001), and by those with male versus female natal sex (p < .001). At least one telehealth visit was completed by 17.98% of patients. Telehealth visit completion was more likely in young adults, female, Black, non-Hispanic, and higher-income patients. Telehealth users were more likely to complete annual sexually transmitted infection testing, had a higher number of visits per year, and had higher odds of requiring a return visit within 2 weeks of the index visit (odds ratio 1.5, 95% confidence intervals 1.41-1.76)., Discussion: Our findings illustrate disparities in telehealth use in this population of economically disadvantaged AYA and provides pragmatic targets for future interventions., (Copyright © 2024 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Most pregnant women in the United States are at risk of inadequate intake of vitamin A, vitamin D, folic acid, calcium, iron, and omega-3 fatty acids from foods alone. Very few United States dietary supplements provide sufficient doses of all 6 nutrients without inducing excess intake., Objective: We aimed to identify energy-efficient foods that provide sufficient doses of these nutrients and could be consumed in lieu of dietary supplements to achieve the recommended intake in pregnancy., Methods: In a previous analysis of 2,450 pregnant women, we calculated the range of additional intake needed to shift 90% of participants to intake above the estimated average requirement and keep 90% below the tolerable upper level for these 6 nutrients. Here, we identified foods and beverages from the 2019 to 2020 Food and Nutrient Database for Dietary Studies that provide target levels of these nutrients without exceeding the additional energy intake recommended for pregnancy beginning in the second trimester (340 kilocalories)., Results: We identified 2358 candidate foods meeting the target intake range for at least one nutrient. No candidate foods provided target amounts of all 6 nutrients. Seaweed (raw or cooked without fat) provided sufficient vitamin A, folate, calcium, iron, and omega-3s (5 of 6 nutrients) but would require an intake of >5 cups/d. Twenty-one other foods/beverages (mainly fish, vegetables, and beverages) provided target amounts of 4 of the 6 nutrients. Few foods met targets for vitamin D (n = 54) or iron (n = 93)., Conclusions: Results highlight the difficulty in meeting nutritional requirements from diet alone and imply that dietary supplements are likely necessary to meet vitamin D and iron targets in pregnancy, as well as omega-3 fatty acid targets for individuals who do not consume fish products. Other foods could be added in limited amounts to help meet intake targets without exceeding caloric recommendations or nutrient safety limits., (Copyright © 2023 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.)

Background: Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting., Methods: The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report perceptions of the DOSE start-up process. In addition to perceptions, metrics analyzed included milestones met, time to start-up, and subsequent enrollment of subjects., Results: Twenty sites were selected for participation, with 19 sites being fully activated. Across activated sites, the median (quartile 1, quartile 3) time from receipt of regulatory documents to site activation was 82 days (68, 113). Sites reported that of the three novel mechanisms, the most motivating factor for expeditious activation was additional funding available for achieving start-up milestones, followed by site navigator assistance and then competitive site activation., Conclusion: Study start-up is a critical time for the success of clinical trials, and innovative methods to minimize delays during start-up are needed. Milestone-based funds and site navigators were preferred mechanisms by sites participating in the DOSE study and may have contributed to the expeditious start-up timeline achieved., Clinicaltrials: gov #: NCT03938857., Competing Interests: Declaration of Competing Interest AEB receives salary support through the US government National Institute of Child Health and Human Development T32 training grant (1T32HD094671). MLB receives salary support from the National Institutes of Health (5R01HD089928–05, 5U24TR001608–4, HHSN275201800003I, 3U24TR001608-04S1), PCORI (PaCr-2017C2–8177), FDA Arthritis Advisory Committee, and the Childhood Arthritis and Rheumatology Research Alliance. CDH has performed consulting services for Tellus Therapeutics and Amarin Pharma, Inc. unrelated to the content of this article. JMC receives salary support from the National Institutes of Health (U24HL135691). RGG and KGA have provided consulting services for industry unrelated to the content of this article. CPH receives salary support for research from National Institute for Child Health and Human Development (NICHD) (R13HD102136; RL1HD107784; R01HD106588), the National Heart Lung and Blood Institute (NHLBI) (R61/R33HL147833), the US Food and Drug Administration (R01-FD006099, PI Laughon; and U18-FD006298), the U.S. government for his work in pediatric clinical pharmacology (Government Contract HHSN275201800003I, PI: Benjamin under the Best Pharmaceuticals for Children Act), the non-profit Burrhoughs Wellcome Fund, and other sponsors for drug development in adults and children (https://dcri.org/about-us/conflict-of-interest/). KOZ received salary support from NICHD (1K23HD091398; Zimmerman), Duke CTSA (KL2TR001115; Zimmerman), Pediatric Trials Network (NIH/HHSN-275201000003I), and FDA (UG3/UH3 FD 006797)., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Neonatal herpes simplex virus (HSV) disease has been treated with high-dose (20 mg/kg/dose) acyclovir since 1991., Aims: Determine the safety of acyclovir in infants with neonatal HSV treated with high-dose acyclovir; examine the association between acyclovir dose and exposure with adverse events (AEs)., Study Design: We obtained demographic information and acyclovir dosing via medical records. Acyclovir exposure was calculated using an established pharmacokinetic model., Subjects: Infants <120 days of age with neonatal HSV discharged from four academic children's hospitals., Outcome Measures: We identified clinical and laboratory adverse events (AEs)., Results and Conclusions: We identified 49 infants with neonatal HSV treated with acyclovir; 42 infants had complete 21-day dosing information. Median mean daily dose was 59 mg/kg/day. Clinical AEs were common among all gestational and postnatal age groups. Rash was the most common clinical AE (37 %). Mild laboratory AEs occurred in 2-37 % of infants. The median maximum doses (mg/kg/day) were higher among infants with hypokalemia, elevated blood urea nitrogen, and thrombocytosis. For all other laboratory AEs, the median maximum doses for infants without events were higher or equal to the median maximum dose of infants with the AE. The odds of experiencing any clinical or laboratory AE did not differ by predicted acyclovir exposure for either area under the curve (AUC) or maximum concentration (Cmax) (odds ratio [OR] = 1.00 [0.98, 1.03] and OR = 1.01 [0.93, 1.12], respectively). Although AEs were common with high-dose acyclovir exposure, severe AEs were rare. Acyclovir exposure was not associated with AEs., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Aryl hydrocarbon receptor (AHR) activation via 2,3,7,8-tetrachlorodibenzofuran (TCDF) induces the accumulation of hepatic lipids. Here we report that AHR activation by TCDF (24  μg/kg body weight given orally for five days) induced significant elevation of hepatic lipids including ceramides in mice, was associated with increased expression of key ceramide biosynthetic genes, and increased activity of their respective enzymes. Results from chromatin immunoprecipitation (ChIP), electrophoretic mobility shift assay (EMSA) and cell-based reporter luciferase assays indicated that AHR directly activated the serine palmitoyltransferase long chain base subunit 2 (Sptlc2, encodes serine palmitoyltransferase 2 (SPT2)) gene whose product catalyzes the initial rate-limiting step in de novo sphingolipid biosynthesis. Hepatic ceramide accumulation was further confirmed by mass spectrometry-based lipidomics. Taken together, our results revealed that AHR activation results in the up-regulation of Sptlc2, leading to ceramide accumulation, thus promoting lipogenesis, which can induce hepatic lipid accumulation., (Copyright © 2021. Published by Elsevier B.V.)

Perfluorooctane sulfonate (PFOS) is a persistent environmental chemical whose biological effects are mediated by multiple mechanisms. Recent evidence suggests that the gut microbiome may be directly impacted by and/or alter the fate and effects of environmental chemicals in the host. Thus, the aim of this study was to determine whether PFOS influences the gut microbiome and its metabolism, and the host metabolome. Four groups of male C57BL/6 J mice were fed a diet with or without 0.003 %, 0.006 %, or 0.012 % PFOS, respectively. 16S rRNA gene sequencing, metabolomic, and molecular analyses were used to examine the gut microbiota of mice after dietary PFOS exposure. Dietary PFOS exposure caused a marked change in the gut microbiome compared to controls. Dietary PFOS also caused dose-dependent changes in hepatic metabolic pathways including those involved in lipid metabolism, oxidative stress, inflammation, TCA cycle, glucose, and amino acid metabolism. Changes in the metabolome correlated with changes in genes that regulate these pathways. Integrative analyses also demonstrated a strong correlation between the alterations in microbiota composition and host metabolic profiles induced by PFOS. Further, using isolated mouse cecal contents, PFOS exposure directly affected the gut microbiota metabolism. Results from these studies demonstrate that the molecular and biochemical changes induced by PFOS are mediated in part by the gut microbiome, which alters gene expression and the host metabolome in mice., Competing Interests: Declaration of Competing Interest John L. Butenhoff, Shu-Ching Chang, were or are employees of 3 M Company, a former manufacturer of PFOS., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Therapeutic hypothermia reduces the risk of death, or moderate to severe neurodevelopmental impairment (NDI) in term infants with hypoxic-ischemic encephalopathy (HIE). Reports of its safety and efficacy in preterm infants are scarce., Objective: Report short and long-term outcomes of preterm infants with HIE who received therapeutic hypothermia., Methods: A retrospective cohort analysis of all preterm infants <36 weeks' gestation with HIE who received whole body hypothermia in a single center from January 2007 to April 2015. The primary outcome was death or moderate to severe NDI defined by moderate or severe cerebral palsy, severe hearing or visual impairment, or cognitive score < 85 on the Bayley Scales of Infant Development III (BSID III) at 18-24 months' adjusted age., Results: 30 infants with a median gestational age and birthweight of 35 weeks' (range; 33-35) and 2575 g (1850-4840) and a median first postnatal blood pH of 6.81 (6.58-7.14). Complications included coagulopathy (50%), early clinical seizures (43.3%), arterial hypotension (40%), persistent metabolic acidosis (37%) and thrombocytopenia (20%). Four infants died before or soon after discharge (18.2%). Eighteen surviving infants (69.2%) had follow up data; 7 of them had moderate to severe NDI (38.9%). Cognitive, motor and language mean composite BSID III scores were 84 (54-110), 83 (46-118), and 78 (46-112). Death or moderate to severe NDI occurred in 11/22 (50%) infants with known outcomes., Conclusion: Large randomized trials on efficacy and safety are needed in this highly vulnerable population as the incidence of complications and the combined outcome of death and NDI is concerning., (Copyright © 2018. Published by Elsevier B.V.)

Background: At very high doses, furosemide is linked to ototoxicity in adults, but little is known about the risk of hearing loss in premature infants exposed to furosemide., Aims: Evaluate the association between prolonged furosemide exposure and abnormal hearing screening in premature infants., Study Design: Using propensity scoring, infants with prolonged (≥28 days) exposure to furosemide were matched to infants never exposed. The matched sample was used to estimate the impact of prolonged furosemide exposure on the probability of an abnormal hearing screen prior to hospital discharge., Subjects: A cohort of infants 501-1250 g birth weight and 23-29 weeks gestational age discharged home from 210 neonatal intensive care units in the United States (2004-2013)., Outcome Measures: We defined abnormal hearing screen as a result of either "fail" or "refer" for either ear., Results: Altogether, 1020 infants exposed to furosemide for ≥28 days were matched to 790 unique infants never exposed, yielding a total of 1042 matches due to sampling with replacement and propensity score ties. Matching resulted in a population similar in baseline characteristics. After adjusting for covariates, the proportion of infants with an abnormal hearing screen in the furosemide-exposed group was not significantly higher than the never-exposed group (absolute difference 3.0% [95% CI -0.2-6.2%], P = 0.07)., Conclusions: Prolonged furosemide exposure was associated with a positive, but not statistically significant, difference in abnormal hearing screening in premature infants. Additional studies with post-hospital discharge audiology follow-up are needed to further evaluate the safety of furosemide in this population., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Lumbar puncture (LP) is the gold standard for diagnosing meningitis; however it is unknown whether early LP (≤3days of life) is associated with increased risk of intraventricular hemorrhage (IVH) in very low birth weight (VLBW) infants., Objective: To determine whether early LP in VLBW infants is associated with severe IVH., Methods: VLBW infants from a cohort of 1,158,789 infants discharged from 382 neonatal intensive care units (1997-2015) were enrolled., Exclusion Criteria: infants with major congenital anomalies, outborns, died/transferred prior to day of life 3, and those who had an LP performed only after day of life 3. Logistic regression was used to determine the association between early LP and the incidence of severe IVH (IVH grades 3/4) by 28days of life for each day of life from day 0 (birth) to day 3, adjusting for clinical covariates., Results: 106,461 infants were included: 754 received an LP on Day-0, 640 on Day-1, 559 on Day-2 and 483 on Day-3. Severe IVH occurred in 4% (4130/104,025) of the infants in the no LP group and 9% (217/2436) of the LP group. Severe IVH was higher for infants with early LP: adjusted OR (95% confidence interval)=2.64 (1.96-3.54) on Day-0; 2.21 (1.61-3.04) on Day-1; 1.55 (1.03-2.34) on Day-2; and 2.25 (1.50-3.38) on Day-3., Conclusions: Early LP was associated with severe IVH in VLBW infants by 28days of life. LP is either a surrogate for an unrecognized factor or is itself associated with an increased risk of IVH., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: The use of parenteral nutrition formulas is often associated with the development of hepatic steatosis. We have shown previously that the addition of a lipid emulsion (LE) rich in n-6 (ω-6) fatty acids (FAs) ameliorated triglyceride (TG) accumulation in the livers of nonobese mice fed a high-carbohydrate diet (HCD) for 5 wk. However, it remains unclear how rapidly this condition develops and whether it can be prevented by LE with or without a running wheel for voluntary exercise (Exe). Objective: We investigated in an 8-d study whether mice develop steatosis and whether the administration of LE with or without Exe reduces the concentration of total FAs and prevents an increase in the expression of genes in the liver associated with lipogenesis. Methods: Male C57BL/6 mice aged 5 wk were randomized into 5 groups: standard feed pellet (SFP); a liquid HCD (77% of total energy from carbohydrates and 0.5% from fat); HCD + Exe; HCD + 13.5% LE (67% carbohydrates and 13.5% fat); or HCD + 13.5% LE + Exe. Hepatic TG concentration, lipogenic genes, and total FAs were measured on day 8. Results: Oil Red O staining and TG quantification showed hepatic TG accumulation on day 8; the addition of 13.5% LE either with or without Exe suppressed the TG accumulation compared with HCD ( P < 0.005). With the use of quantitative reverse transcriptase-polymerase chain reaction analysis, the expression concentrations of lipogenic genes [ATP-citrate lyase, acetyl coenzyme A carboxylase 1, FA synthase ( Fasn ), and stearoyl coenzyme A desaturase 1 ( Scd1 )] in the HCD + 13.5% LE group were 26-60% of HCD ( P < 0.01) and 11-38% of HCD in the HCD + 13.5% LE + Exe group ( P < 0.001), with interactions for Fasn and Scd1 ( P < 0.05). With the use of gas chromatography-mass spectrometry analysis, the HCD + 13.5% LE group had lower monounsaturated fatty acids (38.7% of HCD) but higher polyunsaturated fatty acids (164% of HCD) ( P < 0.001). Conclusions: In short-term studies designed to resemble the early dynamic stage of the development of hepatic steatosis, the addition of 13.5% LE to a liquid HCD reduced hepatic lipogenesis. Exe exerted an independent protective effect and interacted with LE to further reduce the expression of Scd1 ., Competing Interests: 2: Author disclosures: K-H Huang, L Hao, PB Smith, CJ Rogers, AD Patterson, and AC Ross, no conflicts of interest., (© 2017 American Society for Nutrition.)

Background: Gastrostomy tube (G-tube) placement is a common intervention for newborns with severe feeding difficulties. Infants with congenital diaphragmatic hernia (CDH) are at high risk for feeding problems. Prevalence of G-tube placement and consequent nutritional outcomes of infants with CDH and G-tubes has not been described., Aims: Determine factors associated with G-tube placement and growth in infants with congenital diaphragmatic hernia., Study Design: Retrospective cohort study of infants with CDH to evaluate the association of G-tube placement with risk factors using logistic regression. We also assessed the association between growth velocity and G-tube placement and other risk factors using linear regression., Subjects: The subjects of the study were infants with CDH treated at Duke University Medical Center from 1997 to 2013., Outcome Measures: Weight gain in infants with CDH that had G-tube placement compared to those infants with CDH that did not., Result: Of the 123 infants with CDH, 85 (69%) survived and G-tubes were placed in 25/85 (29%) survivors. On adjusted analysis, extracorporeal membrane oxygenation (OR=11.26 [95% CI: 1.92-65.89]; P=0.01) and proton pump inhibitor use (OR=17.29 [3.98-75.14], P≤0.001) were associated with G-tube placement. Infants without G-tubes had a growth velocity of 6.5g/day (95% CI: 2.5-10.4) more than infants with G-tubes., Conclusion: Survivors with more complex inpatient courses were more likely to receive G-tubes. Further investigation is needed to identify optimal feeding practices for infants with CDH., Competing Interests: Conflicts of Interest: None declared., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Hospitalized infants requiring cardiopulmonary resuscitation (CPR) represent a high-risk group. Recent data on risk factors for mortality following CPR in this population are lacking., Aims: We hypothesized that infant demographic characteristics, diagnoses, and levels of cardiopulmonary support at the time of CPR requirement would be associated with survival to hospital discharge following CPR., Study Design: Retrospective cohort study., Subjects: All infants receiving CPR on day of life 2 to 120 admitted to 348 Pediatrix Medical Group neonatal intensive care units from 1997 to 2012., Outcomes Measures: We collected data on demographics, interventions, center volume, and death prior to NICU discharge. We evaluated predictors of death after CPR using multivariable logistic regression with generalized estimating equations to account for clustering of the data by center., Results: Our cohort consisted of 2231 infants receiving CPR. Of these, 1127 (51%) survived to hospital discharge. Lower gestational age, postnatal age, 5-min APGAR, congenital anomaly, and markers of severity of illness were associated with higher mortality. Mortality after CPR did not change significantly over time (Cochran-Armitage test for trend p=0.35)., Conclusions: Mortality following CPR in infants is high, particularly for less mature, younger infants with congenital anomalies and those requiring cardiopulmonary support prior to CPR. Continued focus on at risk infants may identify targets for CPR prevention and improve outcomes., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Histamine-2 receptor (H2) blockers are often used in very low birth weight infants despite lack of population specific efficacy and safety data., Aims: We sought to describe safety and temporal trends in histamine-2 receptor (H2) blocker use in hospitalized very low birth weight (VLBW) infants., Study Design: We conducted a retrospective cohort study using a clinical database populated by an electronic health record shared by 348 neonatal intensive care units in the United States., Subjects: We included all VLBW infants without major congenital anomalies., Outcome Measures: We used multivariable logistic regression with generalizing estimating equations to evaluate the association between days of H2 blocker exposure and risk of: 1) death or necrotizing enterocolitis (NEC); 2) death or sepsis; and 3) death, NEC, or sepsis., Results: Of 127,707 infants, 20,288 (16%) were exposed to H2 blockers for a total of 6,422,352days. Median gestational age for infants exposed to H2 blockers was 27weeks (25th 75th percentile 26, 29). H2 blocker use decreased from 18% of infants in 1997 to 8% in 2012 (p<0.001). On multivariable analysis, infants were at increased risk of the combined outcome of death, NEC, or sepsis on days exposed to H2 blockers (odds ratio=1.14) (95% confidence interval 1.08, 1.19)., Conclusions: H2 blocker use is associated with increased risk of the combined outcome of death, NEC, or sepsis in hospitalized VLBW infants., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Purpose: The purposes were to determine contraceptive methods pregnant adolescents intend to use postpartum and to understand factors that predispose intention to use less effective birth control than long-acting reversible contraception (LARC)., Methods: Participants were 247 pregnant minority adolescents in a prenatal program. Intention was assessed by asking "Which of the following methods of preventing pregnancy do you intend to use after you deliver?" Multinomial logistic regression analysis was used to determine factors associated with intent to use nonhormonal (NH) contraception (male/female condoms, abstinence, withdrawal and no method) or short-/medium-acting hormonal (SMH) contraception (birth control pill, patch, vaginal ring, injectable medroxyprogesterone acetate) compared with LARC (implant and intrauterine device) postpartum., Results: Twenty-three percent intended to use LARC, 53% an SMH method, and 24% an NH method. Participants who intended to use NH or SMH contraceptive methods over LARC were significantly more likely to believe that LARC is not effective at preventing pregnancy, to report that they do not make decisions to help reach their goals and that partners are not important when making contraceptive decisions. Other important factors were having a mother who was aged >19 years at first birth and had not graduated from high school, not having experienced a prior pregnancy or talked with parents about birth control options, and the perception of having limited financial resources., Conclusions: Distinct profiles of factors associated with intending to use NH or SMH contraceptive methods over LARC postpartum were identified and may inform future interventions to promote the use of LARC to prevent repeat pregnancy., (Copyright © 2015 The Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Few studies have reported odds of mortality for hospitalized premature infants stratified by postnatal age and adjusted for severity of illness. Our objective was to examine day-by-day mortality of premature infants in a large multicenter cohort of infants, adjusted for demographics, severity of illness, and receipt of therapeutic interventions., Methods: This was a multicenter cohort study of infants cared for in 362 neonatal intensive care units with a shared clinical data warehouse from 1997 to 2013. We included all inborn infants born at 22-29weeks' gestational age with available mortality discharge data. We report the point prevalence of survival to hospital discharge stratified by gestational and postnatal age., Results: We identified 64,896 infants, of whom 55,348 (85%) survived to hospital discharge. Survival increased with gestational and postnatal age, until infants reached a postmenstrual age of approximately 37weeks, after which survival began to decrease. Overall survival increased over time (80% in 1997 to 88% in 2013, P<.001)., Conclusions: Given the known association between gestational age and postnatal age, survival predictions should be adjusted for both covariates., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Infants born near the limit of viability are at high risk for death or adverse neurodevelopmental outcomes. It is unclear whether these outcomes have improved over the past 15 years., Aim: To determine if death and neurodevelopmental impairment have declined over the past 15 years in infants born at 22 to 24 weeks' gestation., Study Design: Retrospective cohort study., Subjects: We identified infants born at 22 to 24 weeks' gestation in our center in two epochs: 1998-2004 (Epoch 1) and 2005-2011 (Epoch 2)., Outcome Measures: The primary outcome, death or neurodevelopmental impairment, was evaluated at 17-25 months' corrected gestational age with neurologic exams and Bayley Scales of Infant Development. Perinatal characteristics, major morbidities, and outcomes were compared between epochs., Results: Birth weight and gestational age were similar between 170 infants in Epoch 1 and 187 infants in Epoch 2. Mortality was significantly lower in Epoch 2, 55% vs. 42% (p=0.02). Among surviving infants, late-onset sepsis (p<0.01), bronchopulmonary dysplasia (p<0.01), and surgical necrotizing enterocolitis (p=0.04) were less common in Epoch 2. Neurodevelopmental impairment among surviving infants declined from 68% in Epoch 1 to 47% in Epoch 2, p=0.02. Odds of death or NDI were significantly lower in Epoch 2 vs. Epoch 1, OR=0.31 (95% confidence interval; 0.16, 0.58)., Conclusion: Risk of death or neurodevelopmental impairment decreased over time in infants born at 22 to 24 weeks' gestation., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Performing drug trials in pediatrics is challenging. In support of the Best Pharmaceuticals for Children Act, the Eunice Kennedy Shriver National Institute of Child Health and Human Development funded the formation of the Pediatric Trials Network (PTN) in 2010. Since its inception, the PTN has developed strategies to increase both efficiency and safety of pediatric drug trials. Through use of innovative techniques such as sparse and scavenged blood sampling as well as opportunistic study design, participation in trials has grown. The PTN has also strived to improve consistency of adverse event reporting in neonatal drug trials through the development of a standardized adverse event table. We review how the PTN is optimizing operational efficiencies in pediatric drug trials to increase the safety of drugs in children., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Patent ductus arteriosus (PDA) is common in extremely premature infants and associated with increased morbidity and mortality. Medical management of PDA uses either indomethacin or ibuprofen. Despite numerous studies, uncertainty exists as to which drug is safer or more effective; we sought to fill this knowledge gap., Methods: We identified infants <28weeks gestational age discharged from neonatal intensive care units included in the Pediatrix Medical Group Clinical Data Warehouse between 2006 and 2012 who were treated with indomethacin or ibuprofen between postnatal days 2 and 14. Infants treated with both drugs or infants with a congenital malformation were excluded. We used multivariable logistic regression to determine the association of indomethacin versus ibuprofen on clinical outcomes., Results: Of 6349 patients who met study criteria, 1177 (19%) received ibuprofen and 5172 (81%) received indomethacin. The median gestational age was 25weeks (interquartile range 24-26), and 2894 (46%) infants were <750g at birth. On unadjusted analysis, infants who received ibuprofen had significantly higher incidences of death prior to discharge, surgical ligation of the PDA prior to discharge, death or spontaneous intestinal perforation within 7days of therapy, death or surgical ligation of the PDA prior to discharge, and an elevated creatinine within 7days of treatment. However, on multivariable analysis, no significant differences in outcomes were observed (odds ratio for death/PDA ligation for ibuprofen vs. indomethacin=1.12 [95% CI 0.91-1.39])., Conclusions: We observed similar effectiveness and safety profiles for indomethacin and ibuprofen in the medical management of PDA in premature infants., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Octreotide is used off-label in infants for treatment of chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding. The safety profile of octreotide in hospitalized infants has not been described; we sought to fill this information gap., Methods: We identified all infants exposed to at least 1 dose of octreotide from a cohort of 887,855 infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012. We collected laboratory and clinical information while infants were exposed to octreotide and described the frequency of baseline diagnoses, laboratory abnormalities, and clinical adverse events (AEs)., Results: A total of 428 infants received 490 courses of octreotide. The diagnoses most commonly associated with octreotide use were chylothorax (50%), pleural effusion (32%), and hypoglycemia (22%). The most common laboratory AEs that occurred during exposure to octreotide were thrombocytopenia (47/1000 infant-days), hyperkalemia (21/1000 infant-days), and leukocytosis (20/1000 infant-days). Hyperglycemia occurred in 1/1000 infant-days and hypoglycemia in 3/1000 infant-days. Hypotension requiring pressors (12%) was the most common clinical AE that occurred during exposure to octreotide. Necrotizing enterocolitis was observed in 9/490 (2%) courses, and death occurred in 11 (3%) infants during octreotide administration., Conclusion: Relatively few AEs occurred during off-label use of octreotide in this cohort of infants. Additional studies are needed to further evaluate the safety, dosing, and efficacy of this medication in infants., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objective: Supraventricular tachycardia (SVT) is the most common arrhythmia in infants. Infants are typically treated with antiarrhythmic medications, but there is a lack of evidence guiding management, thus exposing infants to risks of both inadequate therapy and medication adverse events. We used data from a large clinical database to better understand current practices in SVT management, safety of commonly used medications, and outcomes of hospitalized infants treated for SVT., Methods: This retrospective data analysis included all infants discharged from Pediatrix Medical Group neonatal intensive care units between 1998 and 2012 with a diagnosis of SVT who were treated with antiarrhythmic medications. We categorized infants by the presence of congenital heart disease other than patent ductus arteriosus. Medications were categorized as abortive, acute, or secondary prevention therapies. We used descriptive statistics to describe medication use, adverse events, and outcomes including SVT recurrence and mortality., Results: A total of 2848 infants with SVT were identified, of whom 367 (13%) had congenital heart disease. Overall, SVT in-hospital recurrence was high (13%), and almost one fifth of our cohort (18%) experienced an adverse event. Mortality was 2% in the overall cohort and 6% in the congenital heart disease group (p<0.001). Adenosine was the most commonly used abortive therapy, but there was significant practice variation in therapies used for acute treatment and secondary prevention of SVT., Conclusion and Practice Implication: Significant variation in SVT treatment and suboptimal outcomes warrant future clinical trials to determine best practices in treating SVT in infants., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: The combination of major congenital heart disease (CHD) and prematurity is associated with poor prognosis, but previous studies have not fully characterized morbidity and mortality in this population. We conducted a retrospective cohort study of very low birth weight (VLBW) infants with major CHD to describe outcomes, including mortality, over time., Methods: We included all infants <1500 g birth weight with major CHD discharged from Pediatrix Medical Group neonatal intensive care units from 1997 to 2012. We report incidences of major CHD in VLBW infants and compare mortality and morbidity by infant birth weight, type of major CHD, and time period., Results: Of 105,539 VLBW infants, 299 (0.3%) were diagnosed with 15 different major CHDs. Coarctation of the aorta (n=67, 22%), atrioventricular septal defect (n=58, 19%), and tetralogy of Fallot (n=53, 18%) were the most common major CHDs identified. Overall mortality was 163/299 (55%). Mortality was ≥70% for 10 lesions and <30% for isolated aortic valve stenosis (6/30, 20%). Mortality in infants with major CHD did not significantly change over time: 76/133 (57%) in 1997-2005, 49/95 (52%) in 2006-2009, and 38/71 (54%) in 2010-2012 (p=0.70). The majority of infants suffered ≥1 comorbidity or died (218/299, 73%)., Conclusion: Major CHD is associated with high morbidity and mortality. While mortality varies by lesion, overall survival and incidence of major morbidity have not improved over time., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Gastroschisis and omphalocele are the most common anterior abdominal wall defects affecting infants. There are few large cohort studies describing the frequency of associated anomalies in infants with these 2 conditions. We describe associated anomalies and outcomes in infants with these defects using a large, multi-center clinical database., Methods: We identified all infants with gastroschisis or omphalocele from a prospectively collected database of infants discharged from 348 neonatal intensive care units in North America from 1997 to 2012. Maternal and patient demographic data, associated anomalies, and outcome data were compared between infants with gastroschisis and omphalocele., Results: A total of 4687 infants with gastroschisis and 1448 infants with omphalocele were identified. Infants with omphalocele were more likely to be diagnosed with at least 1 other anomaly compared with infants with gastroschisis (35% vs. 8%, p<0.001). Infants with omphalocele were more likely to develop pulmonary hypertension compared with those with gastroschisis (odds ratio [OR] 7.78; 95% confidence interval 5.81, 10.41) and had higher overall mortality (OR 6.81 [5.33, 8.71])., Conclusion: Infants with omphalocele were more likely to have other anomalies, be diagnosed with pulmonary hypertension, and have higher mortality than infants with gastroschisis., (Copyright © 2014. Published by Elsevier Ireland Ltd.)

Aims: The objective of this study is to determine the incidence of and risk factors for necrotizing enterocolitis (NEC) and transfusion-associated NEC (TANEC) in very-low-birth-weight (VLBW) infants pre/post implementation of a peri-transfusion feeding protocol., Study Design: A retrospective cohort study was conducted including all inborn VLBW infants admitted to the Duke intensive care nursery from 2002 to 2010. We defined NEC using Bell's modified criteria IIA and higher and TANEC as NEC occurring within 48h of a packed red blood cell (pRBC) transfusion. We compared demographic and laboratory data for TANEC vs. other NEC infants and the incidence of TANEC pre/post implementation of our peri-transfusion feeding protocol. We also assessed the relationship between pre-transfusion hematocrit and pRBC unit age with TANEC., Results: A total of 148/1380 (10.7%) infants developed NEC. Incidence of NEC decreased after initiating our peri-transfusion feeding protocol: 126/939 (12%) to 22/293 (7%), P=0.01. The proportion of TANEC did not change: 51/126 (41%) vs. 9/22 (41%), P>0.99. TANEC infants were smaller, more likely to develop surgical NEC, and had lower mean pre-transfusion hematocrits prior to their TANEC transfusions compared with all other transfusions before their NEC episode: 28% vs. 33%, P<0.001. Risk of TANEC was inversely related to pre-transfusion hematocrit: odds ratio 0.87 (0.79-0.95)., Conclusions: Pre-transfusion hematocrit is inversely related to risk of TANEC, which suggests that temporally maintaining a higher baseline hemoglobin in infants most at risk of NEC may be protective. The lack of difference in TANEC pre-/post-implementation of our peri-transfusion feeding protocol, despite an overall temporal decrease in NEC, suggests that other unmeasured interventions may account for the observed decreased incidence of NEC., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Very low birth weight neonates (≤ 1500 g, VLBWs) have a high rate of infection and distinct baseline immune function compared with more mature populations. In critically ill children and adults, sepsis increases subsequent infection risk. It is unknown whether sepsis modifies the risk of subsequent infection in VLBWs., Methods: We conducted a retrospective cohort study of VLBWs≤32weeks of gestation at birth cared for in 312 neonatal intensive care units in the United States from 1997 to 2011 (n=103,376). Early-onset sepsis (EOS, culture-positive only) and late-onset sepsis (LOS, culture-positive or clinical) cases were identified. Cox proportional hazard models were used to control for clinical variables between neonates with and without EOS to determine if EOS modified risk of LOS, necrotizing enterocolitis (NEC), or death., Results: LOS occurred in 12,112/102,317 (11.8%) neonates without EOS and in 133/1059 (12.6%) of those with EOS. After adjustment for clinical variables, the risk of LOS was not different between neonates with or without a history of EOS (hazard ratio [HR]=0.92; 95% confidence interval [CI] 0.74, 1.16). EOS increased the risk of 120-day mortality (HR=1.78; 95% CI 1.49, 2.13)., Conclusions: In contrast to findings in children and adults, EOS was not associated with an increased risk of LOS in this cohort. Age-specific investigations are needed to determine if post-sepsis immunologic alterations are present., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Background: Very-low-birth-weight (VLBW, <1500 g birth weight) infants are at high risk for both early- and late-onset sepsis. Prior studies have observed a predominance of Gram-negative organisms as a cause of early-onset sepsis and Gram-positive organisms as a cause of late-onset sepsis. These reports are limited to large, academic neonatal intensive care units (NICUs) and may not reflect findings in other units. The purpose of this study was to determine the risk factors for sepsis, the causative organisms, and mortality following infection in a large and diverse sample of NICUs., Methods: We analysed the results of all cultures obtained from VLBW infants admitted to 313 NICUs from 1997 to 2010., Results: Over 108,000 VLBW infants were admitted during the study period. Early-onset sepsis occurred in 1032 infants, and late-onset sepsis occurred in 12,204 infants. Gram-negative organisms were the most commonly isolated pathogens in early-onset sepsis, and Gram-positive organisms were most commonly isolated in late-onset sepsis. Early- and late-onset sepsis were associated with increased risk of death controlling for other confounders (odds ratio 1.45 [95% confidence interval [CI] 1.21,1.73], and OR 1.30 [95%CI 1.21, 1.40], respectively)., Conclusions: This is the largest report of sepsis in VLBW infants to date. Incidence for early-onset sepsis and late-onset sepsis has changed little over this 14-year period, and overall mortality in VLBW infants with early- and late-onset sepsis is higher than in infants with negative cultures., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: Fungal colonisation by Candida spp. affects a high proportion of VLBW neonates in NICU. However, few data are available on the clinical characteristics of colonisation in preterm infants who are colonised at baseline via vertical transmission, compared to preterms who become colonised during their stay in NICU via horizontal transmission., Material and Methods: We reviewed the database of a multicentre, randomised trial of prophylactic fluconazole in VLBW neonates conducted in 8 Italian NICUs in the years 2004 and 2005 (Manzoni et al., NEJM 2007;356(24):2483-95). Per the protocol, all enrolled infants underwent weekly surveillance cultures from birth till discharge. We investigated the frequency of the two different modalities of Candida colonisation in this population, as well as the clinical and outcome characteristics possibly related to them., Results: Overall, Candida colonisation affected 54 of 336 infants (16.1%). Baseline (i.e., detected <3(rd) day of life) colonisation affected 16 (4.7%), and acquired 38 (11.4%), of the 54 colonised preterms. Infants with baseline colonisation had significantly higher birth weight (1229 ± 28 g vs. 1047 g ± 29, p = 0.01) and gestational age (30.2 wks ± 2.7 vs. 28.5 wks ± 2.6, p = 0.01), and were significantly more likely to limit progression from colonisation to invasive Candida infection when fluconazole prophylaxis was instituted (21.6% vs. 42.7%, p = 0.009). Isolation of C. parapsilosis was significantly more frequent in infants with acquired colonisation., Conclusions: Infants with baseline and acquired colonisation differ for demographics characteristics and for their response to fluconazole prophylaxis. This information may be useful for targeting more accurate management strategies for these two different groups of colonised preterms in NICU., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Candida infections are a major cause of morbidity and mortality in neonatal intensive care units. Mortality following Candida bloodstream infections is as high as 40%, and neurodevelopmental impairment is common among survivors. Because invasive fungal infections are common and extremely difficult to diagnose, empirical treatment with antifungal therapy should be considered in high-risk, low-birth-weight infants who fail to quickly respond to empirical antibacterial treatment. Risk factors to consider when deciding to administer empirical antifungal therapy include: prior exposure to third-generation cephalosporins, extreme prematurity, and presence of central venous catheters., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: We sought to describe the incidence, pathogen distribution, and mortality associated with blood culture-proven sepsis in young infants with congenital heart disease (CHD) admitted to a neonatal intensive care unit (NICU)., Methods: Cohort study of all blood cultures obtained from infants with CHD between 4 and 120 days of age cared for in 250 NICUs managed by the Pediatrix Medical Group in the United States between 1996 and 2007., Results: Of 11,638 infants with CHD, 656 (6%) had 821 episodes of sepsis: a cumulative incidence of 71/1000 admissions. Gram-positive organisms were the most common cause (64%), and coagulase-negative Staphylococcus and Staphylococcus aureus were the most frequently isolated species. On multivariable regression, infants with sepsis were more likely to die compared to infants with sterile blood cultures (odds ratio [OR] = 1.53 [95% confidence interval: 1.09, 2.13]). Infants with Gram-negative bacteraemia and candidaemia were more likely to die than infants with sterile blood cultures (OR = 2.01 [1.20, 3.37], and OR = 3.18 [1.60, 6.34], respectively)., Conclusion: Infants with CHD have a high incidence of culture-proven sepsis, especially with staphylococcal organisms. Gram-negative bacteraemia and candidaemia are strongly associated with increased mortality in this group of young infants., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objective: We sought to determine the risk factors, incidence, and mortality of very late onset bacterial infection (blood, urine, or cerebrospinal fluid culture positive occurring after day of life 120) in preterm infants., Study Design: A retrospective observational cohort study of all very low birth weight infants cared for between day of life 120 and 365 in 292 neonatal intensive care units in the United States from 1997 to 2008., Results: We identified 3918 infants who were hospitalized beyond 120 days of life. Of these, 1027 (26%) were evaluated with at least 1 culture (blood, urine, or cerebrospinal fluid), and 276 (27%) of the evaluated infants had 414 episodes of culture-positive infection. Gram-positive organisms caused most of the infections (48%). The risk of death was higher in infants with positive cultures (odds ratio; 10.5, 95% confidence interval [7.2-15.5]) or negative cultures (4.8, [3.5-6.7]) compared to infants that were never evaluated with a culture (p<0.001). Mortality was highest with fungal infections (8/24, 33%) followed by Gram-positive cocci (40/142, 28%)., Conclusions: Important predictive risk factors for early and late onset sepsis (birth weight and gestational age) did not contribute to risk of developing very late onset infection. Evaluation for infection (whether positive or negative) was a significant risk factor for death. GPC and fungal infections were associated with high mortality., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Purpose: We evaluated the prevalence of cardiovascular abnormalities and the efficacy and safety of enzyme replacement therapy in patients with late-onset Pompe disease., Methods: Ninety patients were randomized 2:1 to enzyme replacement therapy or placebo in a double-blinded protocol. Electrocardiograms and echocardiograms were obtained at baseline and scheduled intervals during the 78-week study period. Baseline cardiovascular abnormalities, and efficacy and safety of enzyme replacement therapy were described. Three pediatric patients were excluded., Results: Eighty-seven patients were included. Median age was 44 years; 51% were men. At baseline, a short PR interval was present in 10%, 7% had decreased left ventricular systolic function, and 5% had elevated left ventricular mass on echocardiogram (all in mild range). There was no change in cardiovascular status associated with enzyme replacement therapy. No significant safety concerns related to enzyme replacement therapy were identified., Conclusions: Although some patients with late-onset Pompe disease had abnormalities on baseline electrocardiogram or echocardiogram, those classically seen in infantile Pompe disease, such as significant ventricular hypertrophy, were not noted. Cardiovascular parameters were not impacted by enzyme replacement therapy, and there were no cardiovascular safety concerns. The cardiovascular abnormalities identified may be related to Pompe disease or other comorbid conditions.

Background: Patent ductus arteriosus is a common occurrence among prematurely born neonates and is believed to play a role in the development of other complications of prematurity including intraventricular hemorrhage, bronchopulmonary dysplasia, and necrotizing enterocolitis. The clinical decision to treat the patent ductus arteriosus is complicated by the lack of evidence available regarding clinical conditions under which closure should be attempted., Study Aims: To compare clinical outcomes for neonates who underwent treatment of patent ductus arteriosus exhibiting bidirectional blood flow versus those with flow that was left to right., Study Design: Cohort study of all neonates with patent ductus arteriosus in which medical closure was attempted at the Duke University between January 2002 and October 2007., Outcome Measures: Death and other important clinical conditions., Results: We identified 20 neonates with bidirectional flow out of 317 cases in which medical closure of patent ductus arteriosus was attempted. There was no significant increase in overall complications due to closure of a bidirectional patent ductus arteriosus [40% (8/20)] versus ones with left to right shunting [38% (111/297) p=0.82]. Death occurred in 15% (3/20) with bidirectional PDA compared to 11% (34/297) in the left to right group, p=0.72., Conclusion: The trend in mortality is worrisome but does not contraindicate an aggressive approach to the clinically significant PDA that has bidirectional flow at the time of the echocardiogram., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Background: The impact of age and weight on outcomes after the Fontan operation is unclear. Previous analyses have suggested that lower weight-for-age z-score is an important predictor of poor outcome in patients undergoing bidirectional Glenn. We evaluated variation in age, weight, and weight-for-age z-score at Fontan across institutions, and the impact of these variables on postoperative morbidity and mortality., Methods: Patients in The Society of Thoracic Surgeons Congenital Heart Surgery Database undergoing the Fontan operation (2000 to 2009) were included. Center variation in age, weight, and weight-for-age z-score were described. Multivariable analysis was performed to evaluate the impact of age, weight, and weight-for-age z-score on in-hospital mortality, Fontan failure (combined in-hospital mortality and Fontan takedown/revision), postoperative length of stay, and complications, adjusting for other patient and center factors., Results: A total of 2,747 patients (68 centers) were included: 61% male; 45% right dominant lesions (38% left dominant, 17% undifferentiated). An extracardiac conduit Fontan (versus lateral tunnel) was performed in 63%; 65% were fenestrated. Median age, median weight at Fontan operation, and proportion with weight-for-age z-score less than -2 varied across centers and ranged from 1.7 to 4.8 years, 10.5 to 16.1 kg, and 0% to 30%, respectively. In multivariable analysis, age and weight were not significantly associated with outcome. Weight-for-age z-score less than -2 was associated with increased in-hospital mortality (odds ratio 2.73, 95% confidence interval: 1.09 to 6.86), Fontan failure (odds ratio 2.59, 95% confidence interval: 1.24 to 5.40), and longer length of stay (+1.2 days, 95% confidence interval: 0.1 to 2.4)., Conclusions: Weight-for-age z-score less than -2 is associated with significant morbidity and mortality after the Fontan operation independent of other patient and center characteristics., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Late-onset sepsis in premature infants is a major cause of morbidity, mortality, and increased medical costs. Risk factors include low birth weight, low gestational age, previous antimicrobial exposure, poor hand hygiene, and central venous catheters. Methods studied to prevent late-onset sepsis include early feedings, immune globulin administration, prophylactic antimicrobial administration, and improved hand hygiene. In this review, we will outline the risk factors for development of late-onset sepsis and evidence supporting methods for prevention of late-onset sepsis in premature infants., (Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.)

Background: Seeking screening and treatment for chlamydia (CT) and gonorrhea (GC) by young women is critical to reduction of asymptomatic cervicitis and its complications., Objectives: To evaluate the efficacy of a client-centered motivational behavioral intervention (MBI), to promote seeking of sexually tranmitted infection (STI) checkups by young women., Methods: Three hundred seventy-six of 770 eligible sexually active, nonpregnant, English-speaking women (mean age 18.5 years) were recruited from an urban reproductive health clinic and randomized to two groups: intervention plus standard care (MBI) or standard care alone (SC). MBI (two sessions plus booster) was based on the Transtheoretical Model of Change and employed motivational interviewing. Outcome measures monitored for 12 months included: client-initiated clinic visits for STI checkups in response to seven high-risk sexual behaviors by self-report (primary), consistent condom use, number of CT and GC episodes, and movement along the stages of change obtained at baseline and 6- and 12-month follow-up assessments (secondary). Analyses included chi-square, logistic regression, and generalized estimating equations., Results: At baseline, more than 70% endorsed the action stage of change for seeking STI checkups for three of seven high-risk sexual behaviors. No significant differences were noted between the two groups for the primary or secondary outcomes. Across groups, having multiple partners and being pregnant or thinking one might be pregnant were associated with STI checkups., Conclusions: This is the first known client-centered clinical trial to promote STI screening. Risk-taking and health-seeking behaviors are complex and interrelated with STI and pregnancy concerns. The intervention may have an effect if it is targeted to women in a less medically connected community-based sample., (Copyright 2010 Society for Adolescent Medicine. All rights reserved.)

Considerable effort has been devoted to the development of strategies to reduce the incidence of bronchopulmonary dysplasia (BPD), including use of medications, nutritional therapies, and respiratory care practices. Unfortunately, most of these strategies have not been successful. To date, the only two treatments developed specifically to prevent BPD whose efficacy is supported by evidence from randomized, controlled trials are the parenteral administration of vitamin A and corticosteroids. Two other therapies, the use of caffeine for the treatment of apnea of prematurity and aggressive phototherapy for the treatment of hyperbilirubinemia, were evaluated for the improvement of other outcomes and found to reduce BPD. Cohort studies suggest that the use of continuous positive airway pressure as a strategy for avoiding mechanical ventilation might also be beneficial. Other therapies reduce lung injury in animal models but do not appear to reduce BPD in humans. The benefits of the efficacious therapies have been modest, with an absolute risk reduction in the 7-11% range. Further preventive strategies are needed to reduce the burden of this disease. However, each will need to be tested in randomized, controlled trials, and the expectations of new therapies should be modest reductions of the incidence of the disease.

Objective: Describe cerebrospinal fluid parameters in infants with culture-proven Group B streptococcal meningitis in the era of intrapartum antibiotic prophylaxis., Study Design: Cohort study of the first lumbar puncture from 13,495 infants cared for at 150 neonatal intensive care units. We compared cerebrospinal fluid parameters [white blood cell count, red blood cell count, glucose, and protein], demographics, and outcomes between infants with and without Group B streptococcal meningitis., Results: We identified 46 infants with Group B streptococcal meningitis. The median cerebrospinal fluid white blood cell count was 271 cells/mm(3) for infants with Group B streptococcal meningitis and 6 cells/mm(3) for infants without meningitis (p=0.0001). Of the infants with Group B streptococcal meningitis, 9/46 (20%) had negative blood cultures. Meningitis complicated 22/145 (15%) of episodes of early-onset Group B streptococcal sepsis and 13/23 (57%) of episodes of late-onset Group B streptococcal sepsis., Conclusions: Group B streptococcal meningitis occurs in the presence of negative blood cultures. In hospitalized infants who undergo a lumbar puncture, Group B streptococcal sepsis is frequently complicated by GBS meningitis.

An exploratory study identified correlates of consistent condom use for young women reporting Main-new or Main-old partners in the past 3 months: frequency of vaginal sex (across partner types); perceived likelihood of getting a STI (Main-new); age and STI history (Main-old). To enhance programmatic efficacy in community clinics, these key correlates of condom use for main partner types should be incorporated in STI risk reduction counseling.

Purpose: To assess perceived sexually transmitted disease (STD) (gonorrhea and chlamdydia) screening behaviors among young women at risk for STDs by evaluating readiness, pros and cons, and self-efficacy to seek STD screening in the absence of symptoms., Methods: Two hundred forty young urban women (mean 18.8 years +/-1.59) consecutively attending an urban reproductive clinic voluntarily completed a 67-item questionnaire on STD screening behaviors that included the stages of change (SOCs), decisional balance, and self-efficacy as well as sexual practices and partner relationships. The data were analyzed using descriptive statistics, multivariate analyses of variance, Chi-square tests, and Wilcoxon signed rank test., Results: Ninety-five percent of the participants would be willing to obtain STD screening for early disease detection. Participants were further along the SOCs for STD screening following unprotected sex with a change in partner than main partner, (p <.001). Pros and cons of STD screening varied according to the SOCs for STD screening with a change in partner and main partner. Self-efficacy increased linearly along the SOCs for STD screening (p <.001)., Conclusions: Most young women recognize the importance of STD screening but are not currently being tested when at risk for STDs. STD screening behaviors varied according to the partner relationship, which highlights the importance of stage- and partner-matched counseling to promote STD screening particularly when at risk for STDs.

A study examining the health and behavioral consequences of child abuse was conducted among 263 parenting and 257 never-pregnant teens attending a reproductive health clinic. Both groups of teens identified the following major consequences: suicide, prostitution, school drop-out, crime and substance abuse. However, only parenting teens expressed interest in prevention programs that would address these consequences. Traditional child abuse prevention programs are focused on parenting issues and rarely address health and behavioral consequences of abuse. These health and behavioral consequences of abuse may make adolescents vulnerable to abuse their own children as well as interfere with their psychosocial development. Therefore, the authors recommend integrating health and behavioral issues into child abuse prevention programs.

The purpose of this study was to document the effectiveness of small group condom motivation education in reducing new and reinfection rates of sexually transmitted diseases (STD) among female teenagers. Two hundred and five (205) female adolescents (age 13-20) with a current STD were studied at two sites of a Teen Health Clinic. There were 86 teens in the Study Group and 119 in the Comparison Group. Patients were sampled from December 1992 to July 1993. The patients in the Study Group received a condom motivation class given by the clinic STD educator in small groups of four or more adolescents. The Comparison Group, comparable in age and ethnicity, received treatment for their STD but did not participate in condom motivation classes. All teens were given treatment and condoms. The sample was followed for 6 months. The total number of patients returning with new infections was 21 (14.7%). The total number of patients with reinfections was 14 (9.8%). There were no significant differences between the Study and Comparison Group on return rates, new and reinfection rates or on any socio-demographic variables. The comparison of these groups suggests that a specific condom motivation class has minimal effectiveness in urban teens. However, almost 70% of the teens returned to the clinic for their scheduled visits. It is suggested that adolescent clinics which combine family planning and STD treatment services maintain high client enrollment and therefore may be ideal locations to initiate new and continuous interventions for condom use especially for high risk teens.

The present study described the effectiveness of using an educational program for self-detection of premature labor in a group of forty-one indigent pregnant adolescents. Twenty-one of these teens self-detected premature labor and received appropriate medical intervention; only four had low birthweight infants and three delivered before 37 weeks. The overall results showed a significant use of the program and a high success to failure rate for those who received medical intervention. The cost-effectiveness and usefulness of this protocol in improving medical outcome for indigent teens are discussed.

In the past few years there has been considerable progress in the development of mammalian cell systems for use in genetic toxicology by the stable transfer of genes/cDNAs coding for drug metabolizing enzymes directly into the target cell. Alternative approaches have also been developed in which mammalian cells are transiently transfected with cDNAs coding for drug-metabolizing enzymes and S9 preparations expressing a single metabolizing enzyme isolated and used for metabolic activation. Progress in these areas is reviewed here and the relative merits of the different approaches are discussed. Work to date has focused primarily on the cytochrome P450 family of enzymes, although other enzyme systems involved in xenobiotic metabolism have been used. The central theme of this review is the transfer of genetic information to improve the metabolic capability of cell systems used in genetic toxicology. However, a basic philosophy of the review is that genetic manipulation of cultured mammalian cells has the potential for developing systems to be used to better understand chemically induced toxicological effects.

In order to assess changes from 1986 to 1989 in knowledge, beliefs, and risk factors for AIDS, the responses of inner-city adolescent girls were compared. Although 63% of the 1989 cohort received AIDS education in school, the base knowledge of the two cohorts was not markedly different. Between 1986 and 1989, the number of sexual partners increased for adolescents of all ethnic groups, yet concerns about AIDS showed a decline. Those adolescents who had the highest number of sexual partners were also those who had the most knowledge and most concerns about AIDS. Implications for preventive education focus on ethnic diversity and gaps between adolescent knowledge and behavior.

This retrospective study assessed the return for treatment and test-of-cure rates for gonorrhea and chlamydial infection among 154 adolescents and young adults attending a family planning clinic. Eighty-four percent returned for treatment and 57% of those returned for a test of cure. No statistical differences in race/ethnicity, marital status, gravida, age, presence of symptoms, or type of infection were found between those returning and those not returning for treatment. Issues associated with sexually transmitted disease treatment and follow-up in the family planning clinic setting are discussed.

The development and properties of inductively coupled plasma sources are discussed and their applications to spectrochemical analysis are reviewed. Comparisons are made with other types of plasma source.

The frequencies and potentialities of hematopoietic stem cells from 20-hr-old Xenopus embryos were examined by transplanting cytogenetically distinct ventral blood island tissue from diploid to triploid embryos. Thirty-five-day-old larvae were examined for the presence of donor-derived cells in their erythrocyte, thymocyte, and B lymphocyte populations by analyzing DNA content using flow cytometry. These experiments demonstrated that B lymphocytes, as well as erythrocytes and thymocytes, were derived from the ventral blood island. Data obtained by transplanting graded sized pieces of ventral blood island suggested that restricted erythroid precursors were present within the region by 20 hr postfertilization. Differentiation of both B- and T-lymphoid precursors from small pieces of ventral blood island was markedly enhanced when this tissue was grafted onto peripheral areas within the blood island region. Analysis of these data using repopulation statistics suggested that circulating larval erythrocytes of ventral blood island origin were derived from six or seven precursors. Each lobe of the thymus was colonized by three precursors, one of which was ventral blood island derived.

The use of microwave plasmas and of capacitively coupled high-frequency plasmas as sources for emission spectrochemical analysis is reviewed.