Guidelines for prevention of group B streptococcal (GBS) infection have successfully reduced early onset (EO) GBS disease. Study results suggest that Escherichia coli is an important EO pathogen.
To ...determine EO infection rates, pathogens, morbidity, and mortality in a national network of neonatal centers.
Infants with EO infection were identified by prospective surveillance at Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Network centers. Infection was defined by positive culture results for blood and cerebrospinal fluid obtained from infants aged ≤72 hours plus treatment with antibiotic therapy for ≥5 days. Mother and infant characteristics, treatments, and outcomes were studied. Numbers of cases and total live births (LBs) were used to calculate incidence.
Among 396 586 LBs (2006-2009), 389 infants developed EO infection (0.98 cases per 1000 LBs). Infection rates increased with decreasing birth weight. GBS (43%, 0.41 per 1000 LBs) and E coli (29%, 0.28 per 1000 LBs) were most frequently isolated. Most infants with GBS were term (73%); 81% with E coli were preterm. Mothers of 67% of infected term and 58% of infected preterm infants were screened for GBS, and results were positive for 25% of those mothers. Only 76% of mothers with GBS colonization received intrapartum chemoprophylaxis. Although 77% of infected infants required intensive care, 20% of term infants were treated in the normal newborn nursery. Sixteen percent of infected infants died, most commonly with E coli infection (33%).
In the era of intrapartum chemoprophylaxis to reduce GBS, rates of EO infection have declined but reflect a continued burden of disease. GBS remains the most frequent pathogen in term infants, and E coli the most significant pathogen in preterm infants. Missed opportunities for GBS prevention continue. Prevention of E coli sepsis, especially among preterm infants, remains a challenge.
To investigate the relationships between early blood pressure (BP) changes, receipt of antihypotensive therapy and 18-22 months' corrected age (CA) outcomes for extremely preterm infants.
Prospective ...observational study of infants 23(0/7)-26(6/7) weeks' gestational age (GA). Hourly BP values and antihypotensive therapy exposure in the first 24 h were recorded. Four groups were defined: infants who did or did not receive antihypotensive therapy in whom BP did or did not rise at the expected rate (defined as an increase in the mean arterial BP of ≥5 mm Hg/day). Random-intercept logistic modelling controlling for centre clustering, GA and illness severity was used to investigate the relationship between BP, antihypotensive therapies and infant outcomes.
Sixteen academic centres of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network.
Death or neurodevelopmental impairment/developmental delay (NIDD) at 18-22 months' CA.
Of 367 infants, 203 (55%) received an antihypotensive therapy, 272 (74%) survived to discharge and 331 (90%) had a known outcome at 18-22 months' CA. With logistic regression, there was an increased risk of death/NIDD with antihypotensive therapy versus no treatment (OR 1.836, 95% CI 1.092 to 3.086), but not NIDD alone (OR 1.53, 95% CI 0.708 to 3.307).
Independent of early BP changes, antihypotensive therapy exposure was associated with an increased risk of death/NIDD at 18-22 months' CA when controlling for risk factors known to affect survival and neurodevelopment.
clinicaltrials.gov #NCT00874393.
In this part of a randomized, 2-by-2 factorial trial involving extremely preterm infants, use of intubation and surfactant treatment (within 1 hour after birth) was compared with initiation of ...continuous positive airway pressure (CPAP) in the delivery room and subsequent use of a protocol-driven limited ventilation strategy. The rate of death or bronchopulmonary dysplasia (the primary outcome) did not differ significantly between the groups; the CPAP group required intubation less frequently and for fewer days than did the surfactant group. These results support consideration of CPAP as an alternative to intubation and surfactant in preterm infants.
Use of intubation and surfactant treatment was compared with initiation of CPAP in the delivery room. The rate of death or bronchopulmonary dysplasia did not differ significantly between the groups. The CPAP group required intubation less frequently and for fewer days than did the surfactant group.
It has been shown that surfactant treatment at less than 2 hours of life significantly decreases the rates of death, air leak, and death or bronchopulmonary dysplasia in preterm infants.
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Overall, prophylactic treatment with surfactant has not been shown to significantly reduce the risk of bronchopulmonary dysplasia alone, whereas studies comparing early with later rescue use of surfactant have shown that there is a decreased risk of chronic lung disease with early use.
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Several studies have shown that the use of surfactant does not have a significant effect on the risk of subsequent neurodevelopmental impairment,
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although a recent follow-up . . .
Objective To assess the feasibility of a randomized placebo controlled trial (RCT) of blood pressure (BP) management for extremely preterm infants. Study design This was a prospective pilot RCT of ...infants 23-0/7 to 26-6/7 weeks gestation who had protocol-defined low BP in the first 24 postnatal hours. Enrolled infants were administered a study infusion (dopamine or placebo) and a study syringe medication (hydrocortisone or placebo). Results Of the 366 infants screened, 119 (33%) had low BP, 58 (16%) met all entry criteria, and 10 (3%) were enrolled. A total of 161 infants (44%) were ineligible because they received early indomethacin. Only 17% of eligible infants were enrolled. Problems with consent included insufficient time, parent unavailability, and physician unwillingness to enroll critically ill infants. Two infants were withdrawn from the study because of the potential risk of intestinal perforation with simultaneous administration of hydrocortisone and indomethacin. Conclusions This pilot RCT was not feasible because of low eligibility and consent rates. An RCT of BP management for extremely preterm infants may require a waiver of consent for research in emergency care. The frequent use of early indomethacin and the associated risk of intestinal perforation when used with hydrocortisone may limit future investigations to only inotropic medications.
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IMPORTANCE Gastrostomy tube (GT) placement is the most common gastrointestinal operation performed on neonates. Concomitant fundoplication is used variably to prevent complications of ...gastroesophageal reflux, but its effectiveness is unproven. OBJECTIVE To compare the effect of fundoplication at the time of GT placement vs GT placement alone on subsequent reflux-related hospitalizations in infants with neurological impairment. DESIGN, SETTING, AND PARTICIPANTS Retrospective, observational cohort study, defined by birth between January 1, 2005, and December 31, 2010, at 42 children’s hospitals in the United States, with a 1-year follow-up period among 4163 infants with neurological impairment who underwent GT placement with or without fundoplication during their neonatal intensive care unit stay. INTERVENTION Fundoplication and GT placement vs GT placement alone. MAIN OUTCOMES AND MEASURES One-year postprocedural reflux-related hospitalization rates, defined as hospitalization for asthma, mechanical ventilation, gastroesophageal reflux disease, and aspiration or other types of pneumonia. Propensity to undergo concomitant fundoplication was modeled using demographics, prior procedures (tracheostomy and mechanical ventilation), and prior diagnoses (eg, pneumonia, gastroesophageal reflux disease, and other comorbidities). RESULTS Overall, 4163 of 42 796 infants (9.7%) with neurological impairment admitted to the neonatal intensive care unit underwent GT placement alone or with fundoplication. Infants who concomitantly underwent fundoplication had more reflux-related hospitalizations during the first year than those who underwent GT placement alone (mean, 1.02; 95% CI, 0.93-1.10 vs mean, 0.92; 95% CI, 0.91-1.00). Of 1404 infants who underwent fundoplication, 1027 (73.1%) were matched based on propensity scores. The mean difference of the matched cohort for any reflux-related hospitalizations was −0.05 (95% CI, −0.20 to 0.15) per year. CONCLUSIONS AND RELEVANCE Infants with neurological impairment who underwent fundoplication at the time of GT placement did not have a reduced rate of reflux-related hospitalizations during the first year compared with those who underwent GT placement alone, despite propensity score matching. This may be due to a lack of effectiveness of fundoplication in preventing these complications or due to differences in the patient groups that were inadequately accounted for in the matching.
CONTEXT Current guidelines, initially published in 1995, recommend antenatal corticosteroids for mothers with preterm labor from 24 to 34 weeks' gestational age, but not before 24 weeks due to lack ...of data. However, many infants born before 24 weeks' gestation are provided intensive care. OBJECTIVE To determine if use of antenatal corticosteroids is associated with improvement in major outcomes for infants born at 22 and 23 weeks' gestation. DESIGN, SETTING, AND PARTICIPANTS Cohort study of data collected prospectively on inborn infants with a birth weight between 401 g and 1000 g (N = 10 541) born at 22 to 25 weeks' gestation between January 1, 1993, and December 31, 2009, at 23 academic perinatal centers in the United States. Certified examiners unaware of exposure to antenatal corticosteroids performed follow-up examinations on 4924 (86.5%) of the infants born between 1993 and 2008 who survived to 18 to 22 months. Logistic regression models generated adjusted odds ratios (AORs), controlling for maternal and neonatal variables. MAIN OUTCOME MEASURES Mortality and neurodevelopmental impairment at 18 to 22 months' corrected age. RESULTS Death or neurodevelopmental impairment at 18 to 22 months was significantly lower for infants who had been exposed to antenatal corticosteroids and were born at 23 weeks' gestation (83.4% with exposure to antenatal corticosteroids vs 90.5% without exposure; AOR, 0.58 95% CI, 0.42-0.80), at 24 weeks' gestation (68.4% with exposure to antenatal corticosteroids vs 80.3% without exposure; AOR, 0.62 95% CI, 0.49-0.78), and at 25 weeks' gestation (52.7% with exposure to antenatal corticosteroids vs 67.9% without exposure; AOR, 0.61 95% CI, 0.50-0.74) but not in those infants born at 22 weeks' gestation (90.2% with exposure to antenatal corticosteroids vs 93.1% without exposure; AOR, 0.80 95% CI, 0.29-2.21). If the mothers had received antenatal corticosteroids, the following events occurred significantly less in infants born at 23, 24, and 25 weeks' gestation: death by 18 to 22 months; hospital death; death, intraventricular hemorrhage, or periventricular leukomalacia; and death or necrotizing enterocolitis. For infants born at 22 weeks' gestation, the only outcome that occurred significantly less was death or necrotizing enterocolitis (73.5% with exposure to antenatal corticosteroids vs 84.5% without exposure; AOR, 0.54 95% CI, 0.30-0.97). CONCLUSION Among infants born at 23 to 25 weeks' gestation, antenatal exposure to corticosteroids compared with nonexposure was associated with a lower rate of death or neurodevelopmental impairment at 18 to 22 months.
To identify achieved oxygen saturations (SpO
) associated with increased risk of severe retinopathy of prematurity (ROP).
This is a secondary analysis of the Surfactant Positive Airway Pressure and ...Pulse Oximetry Trial (SUPPORT)randomised controlled trial. SpO
was recorded up to 36 weeks' postmenstrual age. Saturations through 9 postnatal weeks were explored graphically, and logistic regression models were created to predict severe ROP.
20 centres of the
National Institute of Child Health and Human Development Neonatal Research Network.
984 surviving infants of 24-27 weeks' gestational age born in 2005-2009.
SUPPORT targeted SpO
to a lower (85%-89%) or higher (91%-95%) range through 36 weeks' postmenstrual age or off respiratory support.
Severe ROP defined as threshold ROP, ophthalmological surgery or bevacizumab treatment.
There were statistically significant interactions between duration of oxygen supplementation and percentage of time in certain achieved saturation ranges. Specifically, for infants who spent at least 2 weeks on oxygen in postnatal weeks 1-5, a higher percentage of time at 91%-96% SpO
was associated with increased odds of severe ROP. For infants who spent at least 3 weeks on oxygen in postnatal weeks 6-9, a higher percentage of time at 97%-100% SpO
was associated with increased odds of severe ROP. Other significant risk factors were lower gestational age and birth weight, non-Hispanic white versus black race, prospectively defined severe illness, late-onset sepsis or meningitis, and clinical centre.
Among extremely preterm survivors to discharge, the association between SpO
and severe ROP depended on the timing and duration of oxygen supplementation.
This multicenter trial showed no significant differences in the composite outcome of death or neurodevelopmental impairment among extremely preterm infants randomly assigned to early CPAP or early ...surfactant and to lower or higher oxygen saturation.
Extremely premature infants are at high risk for death and neurosensory or developmental impairment in early childhood.
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The risk of neurodevelopmental impairment increases with decreasing gestational age and greater severity of illness. Neurodevelopmental impairment is often a consequence of neonatal complications.
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Although surfactant administration decreases the risk of death and bronchopulmonary dysplasia, randomized, controlled trials of various respiratory interventions have not shown significant reductions in mortality and morbidity or improvement in developmental outcomes.
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We previously reported results of the multicenter, randomized, controlled Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT), which involved extremely premature infants (from . . .
The Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT) antenatal consent study demonstrated that mothers of infants enrolled in the SUPPORT trial had significantly ...different demographics and exposure to antenatal steroids compared with mothers of eligible, but not enrolled infants. The objective of this analysis was to compare the outcomes of bronchopulmonary dysplasia, severe retinopathy of prematurity, severe intraventricular hemorrhage or periventricular leukomalacia (IVH/PVL), death, and death/severe IVH/PVL for infants enrolled in SUPPORT in comparison with eligible, but not enrolled infants.
Perinatal characteristics and neonatal outcomes were compared for enrolled and eligible but not enrolled infants in bivariate analyses. Models were created to test the effect of enrollment in SUPPORT on outcomes, controlling for perinatal characteristics.
There were 1316 infants enrolled in SUPPORT; 3053 infants were eligible, but not enrolled. In unadjusted analyses, enrolled infants had significantly lower rates of death before discharge, severe IVH/PVL, death/severe IVH/PVL (all < 0.001), and bronchopulmonary dysplasia (P = .003) in comparison with eligible, but not enrolled infants. The rate of severe retinopathy of prematurity was not significantly different. After adjustment for perinatal factors, enrollment in the trial was not a significant predictor of any of the tested clinical outcomes.
The results of this analysis demonstrate significant outcome differences between enrolled and eligible but not enrolled infants in a trial using antenatal consent, which were likely due to enrollment bias resulting from the antenatal consent process. Additional research and regulatory review need to be conducted to ensure that large moderate-risk trials that require antenatal consent can be conducted in such a way as to ensure the generalizability of results.
Objective To explore the early childhood pulmonary outcomes of infants who participated in the National Institute of Child Health and Human Development's Surfactant Positive Airway Pressure and Pulse ...Oximetry Randomized Trial (SUPPORT), using a factorial design that randomized extremely preterm infants to lower vs higher oxygen saturation targets and delivery room continuous positive airway pressure (CPAP) vs intubation/surfactant. Study design The Breathing Outcomes Study, a prospective secondary study to the Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial, assessed respiratory morbidity at 6-month intervals from hospital discharge to 18-22 months corrected age (CA). Two prespecified primary outcomes—wheezing more than twice per week during the worst 2-week period and cough longer than 3 days without a cold—were compared for each randomized intervention. Results One or more interviews were completed for 918 of the 922 eligible infants. The incidences of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between the study arms of either randomized intervention. Infants randomized to lower vs higher oxygen saturation targets had a similar risk of death or respiratory morbidity (except for croup and treatment with oxygen or diuretics at home). Infants randomized to CPAP vs intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs 36.5%; P < .05), respiratory illnesses diagnosed by a doctor (47.7% vs 55.2%; P < .05), and physician or emergency room visits for breathing problems (68.0% vs 72.9%; P < .05) by 18-22 months CA. Conclusion Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18-22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates.
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