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Background: Breast milk reduces morbidity and mortality in infants admitted to neonatal intensive care unit (NICU). Objectives: We determined predictors of procuring mother's own milk (MOM) among N...

The timing of antenatal steroids (ANS) on short- and long-term effects on newborn infants was evaluated.This study was conducted at the University of Cincinnati Medical Center Level-III Neonatal Intensive Care Unit by reviewing the medical records of all women with history of ANS exposure from January 2015 to December 2018. We compared outcomes of newborns delivered within the ideal therapeutic window of 24 hours to 7 days (within window [WW]) after administration to those exposed and delivered outside the therapeutic window (outside window primary group [OWP]). Outcomes included anthropometrics, blood sugars, thyroid hormone profile, and neonatal morbidities.A total of 669 patients were identified as having received at least two doses of ANS. Two-thirds of them delivered within the ideal therapeutic window. Significant differences were found in anthroprometrics including lower birth weight, shorter length, and smaller head circumferences in those born within the window compared with those outside the window. Derangements in glucose homeostasis requiring treatment and elevations of thyroid stimulating hormone (TSH) were seen in infants born outside the ideal therapeutic window compared with those born within the therapeutic window. No differences were found in neonatal morbidities including severe intraventricular hemorrhage (sIVH), necrotizing enterocolitis (NEC), need for resuscitation, exogenous surfactant administration, continuous positive airway pressure (CPAP), mechanical ventilation, bronchopulmonary dysplasia (BPD), or periventricular leukomalacia (PVL). After controlling for selected covariates, only birth length was different between the groups.Effects on anthropometrics, glucose homeostasis, and thyroid function support the need to develop new or refine existing risk stratification systems to time the administration of antenatal steroids. Better targeting of women and fetuses may confer the benefits of systemic corticosteroids while mitigating the risks of adverse effects.· The timing of antenatal steroids on short and long-term effects on newborn infants was evaluated.. · Differences were found in anthroprometrics, glucoses, and thyroid function.. · No differences were found in neonatal morbidities..

BackgroundThe objective of this study was to measure skin characteristics in premature (PT), late preterm (LPT), and full-term (FT) neonates compared with adults at two times (T1, T2).MethodsSkin samples of 61 neonates and 34 adults were analyzed for protein biomarkers, natural moisturizing factor (NMF), and biophysical parameters. Infant groups were: ResultsForty proteins were differentially expressed in FT infant skin, 38 in LPT infant skin, and 12 in PT infant skin compared with adult skin at T1. At T2, 40 proteins were differentially expressed in FT infants, 38 in LPT infants, and 54 in PT infants compared with adults. All proteins were increased at both times, except TMG3, S100A7, and PEBP1, and decreased in PTs at T1. The proteins are involved in filaggrin processing, protease inhibition/enzyme regulation, and antimicrobial function. Eight proteins were decreased in PT skin compared with FT skin at T1. LPT and FT proteins were generally comparable at both times. Total NMF was lower in infants than adults at T1, but higher in infants at T2.ConclusionsNeonates respond to the physiological transitions at birth by upregulating processes that drive the production of lower pH of the skin and water-binding NMF components, prevent protease activity leading to desquamation, and increase the barrier antimicrobial properties.ImpactNeonates respond to the transitions at birth by upregulating processes that drive the production of lower pH of the skin and NMF, prevent protease activity leading to desquamation, and increase the antimicrobial properties of the barrier.The neonatal epidermal barrier exhibits a markedly different array of protein biomarkers both shortly after birth and 2–3 months later, which are differentially expressed versus adults.The major biomarker-functional classes included filaggrin processing, protease inhibitor/enzyme regulators, antimicrobials, keratins, lipids, and cathepsins.The findings will guide improvement of infant skin care practices, particularly for the most premature infants with the ultimate goals mitigating nosocomial infection.

OBJECTIVE: To evaluate the effects of early treatment with CPAP on nutritional intake and in-hospital growth rates of extremely preterm (EPT) infants. STUDY DESIGN: EPT infants (24–0/7 to 27–6/7 weeks of gestation) enrolled in the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) were included. EPT infants who died before 36 weeks’ postmenstrual age (PMA) were excluded. The growth rates from birth to 36 weeks’ PMA and follow-up outcomes at 18–22 months’ corrected age of EPT infants randomized at birth to either early CPAP (intervention group) or early intubation for surfactant administration (control group) were analyzed. RESULTS: 810 of 1316 infants enrolled in SUPPORT (414 in intervention group, 396 in control group) had growth data analyzed. Median gestational age was 26 weeks and mean birthweight was 839 grams. Baseline characteristics, total nutritional intake, and in-hospital comorbidities were not significantly different between groups. In a regression model, growth rates between birth and 36 weeks’ PMA as well as growth rates during multiple intervals from birth to day 7, day 7 to14, day 14 to 21, day 21 to 28, day 28 to 32 weeks’ PMA, and 32 weeks’ PMA to 36 weeks’ PMA did not differ between treatment groups. Independent of treatment group, higher growth rates from day 21 to day 28 were associated with a lower risk of Bayley III cognitive score

We tested the hypothesis that sodium supplementation in early preterm infants prevents late-onset hyponatremia and improves growth without increasing common morbidities during birth hospitalization.This was a randomized, masked controlled trial of 4 mEq/kg/d of sodium (intervention) versus sterile water (placebo) from days-of-life 7 to 35 in infants born at32 weeks corrected gestational age. The primary outcome was weight gain in the first 6 weeks of life. Secondary outcomes included weekly serum sodium concentrations, growth in body length and head circumference, and complications of prematurity during birth hospitalization.Fifty-three infants with an average corrected gestational age of 28.5 ± 2.4 weeks were randomized. Infants receiving the intervention had fewer (P = .012) reports of serum sodium concentrations135 mmol/L and greater velocity of weight gain during the study period, mean (SD) 26.9 (3.1) vs 22.9 (4.7) g/kg/day, P = .012. At 6 weeks of age, infants28 weeks' gestation who received sodium supplementation had greater percentage weight change from birth, mean (SD) 193% (22%) vs 173% (10%), P = .041, and maintained fetal reference birth percentile for body weight more often (P = .002) compared with infants receiving placebo. Growth in length and head circumference was not significantly different between study arms. No increase in common prematurity-related morbidities was detected in infants who received supplemental sodium chloride.Sodium supplementation of enteral feedings in very premature infants averts hyponatremia and enhances weight gain.

Objectives To identify variables associated with successful elective extubation, and to determine neonatal morbidities associated with extubation failure in extremely preterm neonates. Study design This study was a secondary analysis of the National Institute of Child Health and Human Development Neonatal Research Network's Surfactant, Positive Pressure, and Oxygenation Randomized Trial that included extremely preterm infants born at 240/7 to 276/7 weeks' gestation. Patients were randomized either to a permissive ventilatory strategy (continuous positive airway pressure group) or intubation followed by early surfactant (surfactant group). There were prespecified intubation and extubation criteria. Extubation failure was defined as reintubation within 5 days of extubation. Results Of 1316 infants in the trial, 1071 were eligible; 926 infants had data available on extubation status; 538 were successful and 388 failed extubation. The rate of successful extubation was 50% (188/374) in the continuous positive airway pressure group and 63% (350/552) in the surfactant group. Successful extubation was associated with higher 5-minute Apgar score, and pH prior to extubation, lower peak fraction of inspired oxygen within the first 24 hours of age and prior to extubation, lower partial pressure of carbon dioxide prior to extubation, and non-small for gestational age status after adjustment for the randomization group assignment. Infants who failed extubation had higher adjusted rates of mortality (OR 2.89), bronchopulmonary dysplasia (OR 3.06), and death/ bronchopulmonary dysplasia (OR 3.27). Conclusions Higher 5-minute Apgar score, and pH prior to extubation, lower peak fraction of inspired oxygen within first 24 hours of age, lower partial pressure of carbon dioxide and fraction of inspired oxygen prior to extubation, and nonsmall for gestational age status were associated with successful extubation. Failed extubation was associated with significantly higher likelihood of mortality and morbidities. Trial registration ClinicalTrials.gov : NCT00233324 .

Objective To characterize actual achieved patterns of oxygenation in infants born appropriate vs small for gestational age (SGA) randomized to a lower (85-89%) vs higher (91%-95%) oxygen saturation target in the Surfactant Positive Pressure and Oxygen Trial. To determine the association between achieved oxygen saturation levels and survival in infants born appropriate vs SGA enrolled in the Surfactant Positive Pressure and Oxygen Trial. Study design Median oxygen saturation and intermittent hypoxemia events ( 0/7 -27 6/7 weeks of gestation while receiving supplemental oxygen during the first 3 days of life. Results Lower target infants who were small for gestational age had the lowest oxygen saturation and highest incidence of intermittent hypoxemia during the first 3 days of life. The lowest quartile of oxygen saturation (≤92%) during the first 3 days of life was associated with lower 90-day survival for both infants born appropriate and SGA. An increased incidence of intermittent hypoxemia events during the first 3 days of life was associated with lower 90-day survival only in infants born SGA. Conclusion Lower achieved oxygen saturation during the first 3 days of life was associated with lower 90-day survival in extremely preterm infants. Infants born SGA had enhanced vulnerability to lower oxygen saturation targets as evidenced by lower achieved oxygen saturation and an association between increased intermittent hypoxemia events and lower survival. Trial registration ClinicalTrials.gov: NCT00233324.

Objective To explore differences in blood cytokine profiles among distinct bronchopulmonary dysplasia (BPD) patterns. Study design We evaluated blood spots collected from 943 infants born at ≤1000 g and surviving to 28 days on postnatal days 1, 3, 7, 14, and 21 for 25 cytokines. Infants were assigned to the following lung disease patterns: (1) no lung disease (NLD); (2) respiratory distress syndrome without BPD; (3) classic BPD (persistent exposure to supplemental oxygen until 28 days of age); or (4) atypical BPD (period without supplemental oxygen before 28 days). Median cytokine levels for infants with BPD were compared with the IQR of results among infants with NLD. Results The distribution of enrolled infants by group was as follows: 69 (NLD), 73 (respiratory distress syndrome), 381 (classic BPD), and 160 (atypical BPD). The remaining 260 infants could not be classified because of missing data (104) or not fitting a predefined pattern (156). Median levels of 3 cytokines (elevated interleukin [IL]-8, matrix metalloproteinase-9; decreased granulocyte macrophage colony-stimulating factor) fell outside the IQR for at least 2 time points in both infants with atypical and classic BPD. Profiles of 7 cytokines (IL-6, IL-10, IL-18, macrophage inflammatory protein-1α, C-reactive protein, brain-derived neurotrophic factor, regulated on activation, normal T cell expressed and secreted) differed between infants with classic and atypical BPD. Conclusions Blood cytokine profiles may differ between infants developing classic and atypical BPD. These dissimilarities suggest the possibility that differing mechanisms could explain the varied patterns of pathophysiology of lung disease in extremely premature infants.

The objective of this study is to assess the opportunities afforded to and competence of pediatric residents in performing neonatal endotracheal intubations.The records of all intubations performed on neonates over a 3-year period at a university-based birthing hospital were reviewed to assess the relationships between outcomes, types of providers and the setting of intubations.A total of 785 attempts were made during 362 intubations. Pediatric residents were given the opportunity to intubate 38% of the cohort (n=137) and were successful on 21% of the attempts. Residents were more likely to perform intubation in the neonatal intensive care unit (vs delivery room; P0.001), in non-emergency situations (P0.001), and on older (P0.001) and larger (P=0.07) infants.Opportunities for residents to intubate neonates were few and their success rate was low. In the current care paradigm, it is doubtful if trainees can be sufficiently skilled in endotracheal intubation during residency. Residents that plan to pursue procedure-intensive subspecialties may benefit from other models for training.

To test whether infants randomized to a lower oxygen saturation (peripheral capillary oxygen saturation [SpO2]) target range while on supplemental oxygen from birth will have better growth velocity from birth to 36 weeks postmenstrual age (PMA) and less growth failure at 36 weeks PMA and 18-22 months corrected age.We evaluated a subgroup of 810 preterm infants from the Surfactant, Positive Pressure, and Oxygenation Randomized Trial, randomized at birth to lower (85%-89%, n = 402, PMA 26 ± 1 weeks, birth weight 839 ± 186 g) or higher (91%-95%, n = 408, PMA 26 ± 1 weeks, birth weight 840 ± 191 g) SpO2 target ranges. Anthropometric measures were obtained at birth, postnatal days 7, 14, 21, and 28; then at 32 and 36 weeks PMA; and 18-22 months corrected age. Growth velocities were estimated with the exponential method and analyzed with linear mixed models. Poor growth outcome, defined as weight10th percentile at 36 weeks PMA and 18-22 months corrected age, was compared across the 2 treatment groups by the use of robust Poisson regression.Growth outcomes including growth at 36 weeks PMA and 18-22 months corrected age, as well as growth velocity were similar in the lower and higher SpO2 target groups.Targeting different oxygen saturation ranges between 85% and 95% from birth did not impact growth velocity or reduce growth failure in preterm infants.

Objective: To examine the relationship of race and maternal characteristics and their association with cord blood vitamin D levels and small-for-gestational-age (SGA) status. Study Design: Cord blood vitamin D levels were measured in 438 infants (276 black and 162 white). Multivariable logistic regression models were used to evaluate associations between maternal characteristics, vitamin D status and SGA. Results: Black race, Medicaid status, mean body mass index at delivery and lack of prenatal vitamin use were associated with vitamin D deficiency. Black infants had 3.6 greater adjusted odds (95% confidence interval (CI): 2.4, 5.6) of vitamin D deficiency when compared with white infants. Black infants with vitamin D deficiency had 2.4 greater adjusted odds (95% CI: 1.0, 5.8) of SGA. Vitamin D deficiency was not significantly associated with SGA in white infants. Conclusion: Identification of risk factors (black race, Medicaid status, obesity and lack of prenatal vitamin use) can lead to opportunities for targeted prenatal vitamin supplementation to reduce the risk of neonatal vitamin D deficiency and SGA status.

To compare continuous positive airway pressure (CPAP) vs. traditional mechanical ventilation (MV) at 24 h of age as predictors of neurodevelopmental (ND) outcomes in extremely low birth weight (ELBW) infants at 18–22 months corrected gestational age (CGA). Infants ≤1000 g birth weight born from January 2000 through December 2006 at two hospitals at the Cincinnati site of the National Institute of Child Health and Human Development Neonatal Research Network were evaluated comparing CPAP (n = 198) vs. MV (n = 109). Primary outcomes included the Bayley Score of Infant Development Version II (BSID-II), presence of deafness, blindness, cerebral palsy, bronchopulmonary dysplasia and death. Ventilatory groups were similar in gender, rates of preterm prolonged rupture of membranes, antepartum hemorrhage, use of antenatal antibiotics, steroids, and tocolytics. Infants receiving CPAP weighed more, were older, were more likely to be non-Caucasian and from a singleton pregnancy. Infants receiving CPAP had better BSID-II scores, and lower rates of BPD and death. After adjusting for acuity differences, ventilatory strategy at 24 h of age independently predicts long-term neurodevelopmental outcome in ELBW infants.

Epidermal innate immunity is a complex process involving a balance of pro- and anti-inflammatory cytokines, structural proteins, and specific antigen presenting cells occurring against a background of neuroendocrine modulators such as cortisol. In this study, a multiplex array system was used to simultaneously determine multiple molecular factors critical for development of epidermal innate immune function from the skin surface of premature and term infants, healthy adults, and vernix caseosa. Samples were analyzed for Keratin 1,10,11, Keratin 6, involucrin, albumin, fibronectin and cortisol, and cytokines IL-1, TNFalpha, IL-6, IL-8, MCP1, IP10, IFNgamma, and IL-1 receptor antagonist. Keratin 1,10,11 was decreased and involucrin was increased in infants versus adults. All infants had elevated IL1alpha and reduced TNFalpha versus adults. IL-6, IL-8, and MCP1 were significantly increased in premature versus term infants and adults. Skin surface cortisol and albumin were significantly elevated in premature infants. The biomarker profile in premature infants was unique with differences in structural proteins, albumin, and cytokines IL-6, IL-1beta, IL-8, and MCP1. The higher infant IL1alpha may be associated with skin barrier maturation. The significant elevations in skin surface cortisol for preterm infants may reflect a neuroendocrine response to the stress of premature birth.

To characterize vernix caseosa in newborn infants with respect to factors that influence vernix distribution on the skin surface, vernix effects on thermal stability, skin hydration, acid mantle development, and vernix antioxidant properties. Vernix distribution was determined for 430 infants. Thermal stability was assessed in parallel groups following vernix retention (n=66) and removal (n=64). The effects of vernix retention on skin hydration, pH, erythema, and dryness/scaling were determined. Samples were analyzed for vitamin E before and after UV exposure. Vernix distribution depended upon gestational age, delivery mode, gender, race, and meconium exposure. Retention had no effect on axillary temperatures. Skin hydration was significantly higher for vernix-retained skin. Skin pH and erythema were significantly lower with retention. Vitamin E levels were decreased by ultraviolet radiation. Vernix is a naturally occurring barrier cream with multiple salubrious effects, which support its retention on the skin surface at birth.

Objective This study was undertaken to define the spectrum, activity, and spatial distribution of antimicrobial peptides in vernix caseosa and amniotic fluid in the absence of clinical chorioamnionitis. Study design Characterization of innate immune proteins in vernix and amniotic fluid obtained from pregnancies with gestational ages greater than 37 weeks by Western analysis, immunohistochemistry, and antimicrobial growth inhibition assay. Results Lysozyme, lactoferrin, human neutrophil peptides 1-3, and secretory leukocyte protease inhibitor were identified by Western analysis in vernix suspensions (n=25) and amniotic fluid samples (n=10). Three other important antimicrobial proteins, human beta defensin-2, lactoperoxidase, and LL-37 were not detected. Amniotic fluid and soluble extracts of vernix exhibited muramidase (lysozyme) activity, and there was selective efficacy in inhibiting growth of common perinatal pathogens. Antimicrobial peptides were concentrated in discrete, organized, acellular "granules" embedded in the vernix lipid matrix. Conclusion In the absence of chorioamnionitis, vernix and amniotic fluid contain an organized pool of antimicrobial peptides with a defined spectrum of bioactivity against common bacterial and fungal pathogens.

OBJECTIVE: To test whether the introduction of early bubble continuous positive airway pressure (CPAP) results in improved respiratory outcomes in extremely low birth-weight infants. STUDY DESIGN: Outcomes of all infants between 401 and 1000 g born in a level 3 neonatal intensive care units (NICU) between July 2000 and October 2001 (period 2) were compared using historical controls (period 1). Early bubble (CPAP) was prospectively introduced in the NICU during period 1. Univariate and adjusted comparisons were made across time periods. RESULTS: Delivery room intubations, days on mechanical ventilation and use of postnatal steroids decreased (p

OBJECTIVES: To test the hypothesis that the promotion of national guidelines recommending the transfer of high-risk mothers to subspecialty perinatal centers reduces mortality and morbidity through the reduction of preterm infants delivered at nontertiary maternity hospitals. METHODS: After implementation of hospital-based educational and communication programs emphasizing the importance of maternal transfer to subspecialty perinatal centers, we conducted a population-based cohort study of all live births delivered at maternity hospitals in greater Cincinnati from 2003 through 2007 (n = 1825). Birth weights measured between 500 and 1499 g and gestational ages were less than 32 weeks. Risk-adjusted outcomes were measured by multivariate logistic regression in 2 stages. We compared these findings with those from a similar study conducted at our institution that included infants with birth weights less than 1500 g born between September 1, 1995, and December 31, 1997 (n = 848). The primary outcome was the percentage decrease in infants born with very low birth weights at nontertiary centers compared with our previous study. RESULTS: The number of infants born with birth weights less than 1500 g and at less than 32 weeks' gestation delivered at hospitals without tertiary perinatal and neonatal care decreased from 25% to 11.8% between the 2 study periods. The odds of death or major morbidity for infants born with very low birth weights at nontertiary perinatal centers is 3 times that of infants born at subspecialty perinatal centers after controlling for demographic variations (odds ratio: 3.05 [95% confidence interval: 2.1–4.4]). CONCLUSIONS: Local promotion of national guidelines by neonatologists coincided with a significant reduction in the percentage of infants born with birth weights less than 1500 g and at less than 32 weeks' gestation who were not delivered at subspecialty perinatal centers, and, at 88.2%, this nearly achieves the Healthy People 2010 objective to deliver 90% of infants born with very low birth weights in subspecialty perinatal centers.

Background/Aims: Premature infants lack the vernix caseosa, have an incompetent stratum corneum (SC) barrier and are predisposed to infection. Use of topical agents to improve barrier function has had mixed outcomes. The aim was to determine the effect of vernix versus common barrier creams on the rate and quality of the epidermal barrier repair following controlled wounding. Methods: Minor wounds were created with (1) laser ablation in the minipig and (2) tape stripping of mother’s volar skin as a model for premature skin. Native vernix was applied to the mother’s tape-stripped skin. Treatments were no occlusion (NO), vernix and a petrolatum-based cream (PBC) in the pig, and NO, vernix, PBC, an oil-in-water cream (OWC), a semipermeable film (SP) and full occlusion (FO) in adults. Results: Outcomes for both trials were barrier recovery and skin hydration (moisture accumulation rate, MAT), initial hydration, erythema and dryness in adults. Vernix and PBC produced greater barrier repair than NO in the pig. SP produced greater recovery than NO and FO in adults. Vernix yielded greater recovery than FO and was similar to PBC, OWC and NO. Vernix had a directionally higher MAT than OWC and directionally higher initial hydration than NO. Conclusions: The findings suggest that vernix-based topical creams would be effective for the treatment of epidermal wounds and show promise to augment SC repair and maturation in infants.

Objectives To compare the spectrum, concentration, and activity of host defense proteins (HDPs) on the skin surface of newborns and adults, to assess variation in HDP concentrations in different anatomic regions in newborns, and to examine alteration in HDP concentrations with care practices. Study design Proteins recovered from tape discs applied to stratum corneum of 25 term newborns (forehead and posterior trunk) and 20 adults (forehead) were analyzed by Western analysis for 5 HDPs and for muramidase activity. Protein concentrations were compared in samples obtained after delivery, after the first bath, and at 24 hours of age. Results Total protein was 2.8-fold higher in adults compared with newborns. Lysozyme and lactoferrin were detected in all samples. In contrast to total protein, lysozyme concentrations and muramidase activity were 5-fold higher in newborns relative to adults and were not altered after bathing. Lysozyme concentrations were significantly higher over the trunk compared with the forehead in newborns. Conclusions The newborn skin surface is replete with prototypical HDPs, lysozyme, and lactoferrin. Bathing does not significantly diminish concentrations. These factors are likely to contribute importantly to the newborn infants' defense against invasive bacterial infections.

To study the efficacy of yoga on pregnancy outcomes.Three hundred thirty five (335) women attending the antenatal clinic at Gunasheela Surgical and Maternity Hospital in Bangalore, India, were enrolled between 18 and 20 weeks of pregnancy in a prospective, matched, observational study; 169 women in the yoga group and 166 women in the control group.Women were matched for age, parity, body weight, and Doppler velocimetry scores of umbilical and uterine arteries. Yoga practices, including physical postures, breathing, and meditation were practiced by the yoga group one hour daily, from the date of entry into the study until delivery. The control group walked 30 minutes twice a day (standard obstetric advice) during the study period. Compliance in both groups was ensured by frequent telephone calls and strict maintenance of an activity diary.Birth weight and gestational age at delivery were primary outcomes.The number of babies with birth weightor = 2500 grams was significantly higher (p0.01) in the yoga group. Preterm labor was significantly lower (p0.0006) in the yoga group. Complications such as isolated intrauterine growth retardation (IUGR) (p0.003) and pregnancy-induced hypertension (PIH) with associated IUGR (p0.025) were also significantly lower in the yoga group. There were no significant adverse effects noted in the yoga group.An integrated approach to yoga during pregnancy is safe. It improves birth weight, decreases preterm labor, and decreases IUGR either in isolation or associated with PIH, with no increased complications.

Background. Glutamine is one of the most abundant amino acids in both plasma and human milk, yet it is not included in standard intravenous amino acid solutions. Previous studies have suggested that parenteral nutrition (PN) supplemented with glutamine may reduce sepsis and mortality in critically ill adults. Whether glutamine supplementation would provide a similar benefit to extremely low birth weight (ELBW) infants is not known. Methods. We performed a multicenter, randomized, double-masked, clinical trial to assess the safety and efficacy of early PN supplemented with glutamine in decreasing the risk of death or late-onset sepsis in ELBW infants. Infants 401 to 1000 g were randomized within 72 hours of birth to receive either TrophAmine (control) or an isonitrogenous study amino acid solution with 20% glutamine whenever they received PN up to 120 days of age, death, or discharge from the hospital. The primary outcome was death or late-onset sepsis. Results. Of the 721 infants who were assigned to glutamine supplementation, 370 (51%) died or developed late-onset sepsis, as compared with 343 of the 712 infants (48%) assigned to control (relative risk: 1.07; 95% confidence interval: 0.97–1.17). Glutamine had no effect on tolerance of enteral feeds, necrotizing enterocolitis, or growth. No significant adverse events were observed with glutamine supplementation. Conclusions. Parenteral glutamine supplementation as studied did not decrease mortality or the incidence of late-onset sepsis in ELBW infants. Consequently, although no harm was demonstrated, routine use of parenteral glutamine supplementation cannot be recommended in this population.

BACKGROUND Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes. METHODS We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant. RESULTS The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P