Among hospitals in the NICHD Neonatal Research Network, rates of active treatment of infants born at 22 to 24 weeks of gestation varied substantially and accounted for a substantial proportion of ...between-hospital variation in overall survival and survival without impairment.
The decision to initiate or forgo potentially lifesaving treatment in infants who are born near the limit of viability is extremely difficult.
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Clinicians recognize that in some cases, the infant is too immature for treatment to be effective, whereas in other cases, treatment is clearly indicated. Yet, in many cases, it is unclear whether treatment is in the infant’s best interest.
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Although factors such as the infant’s birth weight and sex, plurality of birth (singleton vs. multiple), and exposure to antenatal glucocorticoids affect the prognosis of extremely preterm infants,
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many groups still make recommendations about active treatment . . .
IMPORTANCE: The Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (NRN) extremely preterm birth outcome model is widely used for ...prognostication by practitioners caring for families expecting extremely preterm birth. The model provides information on mean outcomes from 1998 to 2003 and does not account for substantial variation in outcomes among US hospitals. OBJECTIVE: To update and validate the NRN extremely preterm birth outcome model for most extremely preterm infants in the United States. DESIGN, SETTING, AND PARTICIPANTS: This prognostic study included 3 observational cohorts from January 1, 2006, to December 31, 2016, at 19 US centers in the NRN (derivation cohort) and 637 US centers in Vermont Oxford Network (VON) (validation cohorts). Actively treated infants born at 22 weeks’ 0 days’ to 25 weeks’ 6 days’ gestation and weighing 401 to 1000 g, including 4176 in the NRN for 2006 to 2012, 45 179 in VON for 2006 to 2012, and 25 969 in VON for 2013 to 2016, were studied. VON cohorts comprised more than 85% of eligible US births. Data analysis was performed from May 1, 2017, to March 31, 2019. EXPOSURES: Predictive variables used in the original model, including infant sex, birth weight, plurality, gestational age at birth, and exposure to antenatal corticosteroids. MAIN OUTCOMES AND MEASURES: The main outcome was death before discharge. Secondary outcomes included neurodevelopmental impairment at 18 to 26 months’ corrected age and measures of hospital resource use (days of hospitalization and ventilator use). RESULTS: Among 4176 actively treated infants in the NRN cohort (48% female; mean SD gestational age, 24.2 0.8 weeks), survival was 63% vs 62% among 3702 infants in the era of the original model (47% female; mean SD gestational age, 24.2 0.8 weeks). In the concurrent (2006-2012) VON cohort, survival was 66% among 45 179 actively treated infants (47% female; mean SD gestational age, 24.1 0.8 weeks) and 70% among 25 969 infants from 2013 to 2016 (48% female; mean SD gestational age, 24.1 0.8 weeks). Model C statistics were 0.74 in the 2006-2012 validation cohort and 0.73 in the 2013-2016 validation cohort. With the use of decision curve analysis to compare the model with a gestational age–only approach to prognostication, the updated model showed a predictive advantage. The birth hospital contributed equally as much to prediction of survival as gestational age (20%) but less than the other factors combined (60%). CONCLUSIONS AND RELEVANCE: An updated model using well-known factors to predict survival for extremely preterm infants performed moderately well when applied to large US cohorts. Because survival rates change over time, the model requires periodic updating. The hospital of birth contributed substantially to outcome prediction.
Periviable births are those occurring from 20 0/7 through 25 6/7 weeks of gestation. Among and within developed nations, significant variation exists in the approach to obstetric and neonatal care ...for periviable birth. Understanding gestational age-specific survival, including factors that may influence survival estimates and how these estimates have changed over time, may guide approaches to the care of periviable births and inform conversations with families and caregivers. This review provides a historical perspective on survival following periviable birth, summarizes recent and new data on gestational age-specific survival rates, and addresses factors that have a significant impact on survival.
Objective To document the mortality and morbidity of infants weighing 501-1500 g at birth according to gestational age, birthweight, and sex. Study design Prospective collection of perinatal events ...and neonatal course to 120 days of life, discharge, or death from January 1990 through December 2002 for infants born at 16 participating centers of the National Institute of Child Health & Human Development Neonatal Research Network. Results Compared with 1995-1996, for 1997-2002 the survival of infants with birthweight of 501-1500 g increased by 1 percentage point (from 84% to 85%). Survival without major neonatal morbidity remained static, at 70%; this includes bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), and necrotizing enterocolitis (NEC). Survival increased for multiple births (26%, up from 22%), antenatal corticosteroid use (79%, up from 71%), and maternal antibiotics (70%, up from 62%) ( P < .05). From 1997 to 2002, birthweight-specific survival was 55% for infants weighing 501-750 g, 88% for 751-1000 g, 94% for 1001-1250 g, and 96% for 1251–1500 g. More females survived. The incidence of NEC (7%), severe IVH (12%), and late-onset septicemia (22%) remained essentially unchanged, but BPD decreased slightly, from 23% to 22%. The use of postnatal corticosteroids declined from 20% in 1997-2000 to 12% in 2001-2002. Growth failure (weight <10th percentile) at 36 weeks’ postmenstrual age decreased from 97% in 1995-1996 to 91% in 1997-2002. Conclusion There have been no significant increases in survival without neonatal and long-term morbidity among VLBW infants between 1997 and 2002. We speculate that to improve survival without morbidity requires determining, disseminating, and applying best practices using therapies currently available, and also identifying new strategies and interventions.
To describe the spectrum of cognitive outcomes of children with and without cerebral palsy (CP) after neonatal encephalopathy, evaluate the prognostic value of early developmental testing and report ...on school services and additional therapies.
The participants of this study are the school-aged survivors of the National Institute of Child Health and Human Development Neonatal Research Network randomized controlled trial of whole-body hypothermia. Children underwent neurologic examinations and neurodevelopmental and cognitive testing with the Bayley Scales of Infant Development-II at 18 to 22 months and the Wechsler intelligence scales and the Neuropsychological Assessment-Developmental Neuropsychological Assessment at 6 to 7 years. Parents were interviewed about functional status and receipt of school and support services. We explored predictors of cognitive outcome by using multiple regression models.
Subnormal IQ scores were identified in more than a quarter of the children: 96% of survivors with CP had an IQ <70, 9% of children without CP had an IQ <70, and 31% had an IQ of 70 to 84. Children with a mental developmental index <70 at 18 months had, on average, an adjusted IQ at 6 to 7 years that was 42 points lower than that of those with a mental developmental index >84 (95% confidence interval, -49.3 to -35.0; P < .001). Twenty percent of children with normal IQ and 28% of those with IQ scores of 70 to 84 received special educational support services or were held back ≥1 grade level.
Cognitive impairment remains an important concern for all children with neonatal encephalopathy.
Objective To examine the predictive ability of stage of hypoxic-ischemic encephalopathy (HIE) for death or moderate/severe disability at 18 months among neonates undergoing hypothermia. Study design ...Stage of encephalopathy was evaluated at <6 hours of age, during study intervention, and at discharge among 204 participants in the National Institute of Child Health and Human Development Neonatal Research Network Trial of whole body hypothermia for HIE. HIE was examined as a predictor of outcome by regression models. Results Moderate and severe HIE occurred at <6 hours of age among 68% and 32% of 101 hypothermia group infants and 60% and 40% of 103 control group infants, respectively. At 24 and 48 hours of study intervention, infants in the hypothermia group had less severe HIE than infants in the control group. Persistence of severe HIE at 72 hours increased the risk of death or disability after controlling for treatment group. The discharge exam improved the predictive value of stage of HIE at <6 hours for death/disability. Conclusions On serial neurologic examinations, improvement in stage of HIE was associated with cooling. Persistence of severe HIE at 72 hours and an abnormal neurologic exam at discharge were associated with a greater risk of death or disability.
IMPORTANCE: Patient-centered medical homes have not been shown to reduce adverse outcomes or costs in adults or children with chronic illness. OBJECTIVE: To assess whether an enhanced medical home ...providing comprehensive care prevents serious illness (death, intensive care unit ICU admission, or hospital stay >7 days) and/or reduces costs among children with chronic illness. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of high-risk children with chronic illness (≥3 emergency department visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions during previous year, and >50% estimated risk for hospitalization) treated at a high-risk clinic at the University of Texas, Houston, and randomized to comprehensive care (n = 105) or usual care (n = 96). Enrollment was between March 2011 and February 2013 (when predefined stopping rules for benefit were met) and outcome evaluations continued through August 31, 2013. INTERVENTIONS: Comprehensive care included treatment from primary care clinicians and specialists in the same clinic with multiple features to promote prompt effective care. Usual care was provided locally in private offices or faculty-supervised clinics without modification. MAIN OUTCOMES AND MEASURES: Primary outcome: children with a serious illness (death, ICU admission, or hospital stay >7 days), costs (health system perspective). Secondary outcomes: individual serious illnesses, medical services, Medicaid payments, and medical school revenues and costs. RESULTS: In an intent-to-treat analysis, comprehensive care decreased both the rate of children with a serious illness (10 per 100 child-years vs 22 for usual care; rate ratio RR, 0.45 95% CI, 0.28-0.73), and total hospital and clinic costs ($16 523 vs $26 781 per child-year, respectively; cost ratio, 0.58 95% CI, 0.38-0.88). In analyses of net monetary benefit, the probability that comprehensive care was cost neutral or cost saving was 97%. Comprehensive care reduced (per 100 child-years) serious illnesses (16 vs 44 for usual care; RR, 0.33 95% CI, 0.17-0.66), emergency department visits (90 vs 190; RR, 0.48 95% CI, 0.34-0.67), hospitalizations (69 vs 131; RR, 0.51 95% CI, 0.33-0.77), pediatric ICU admissions (9 vs 26; RR, 0.35 95% CI, 0.18-0.70), and number of days in a hospital (276 vs 635; RR, 0.36 95% CI, 0.19-0.67). Medicaid payments were reduced by $6243 (95% CI, $1302-$11 678) per child-year. Medical school losses (costs minus revenues) increased by $6018 (95% CI, $5506-$6629) per child-year. CONCLUSIONS AND RELEVANCE: Among high-risk children with chronic illness, an enhanced medical home that provided comprehensive care to promote prompt effective care vs usual care reduced serious illnesses and costs. These findings from a single site of selected patients with a limited number of clinicians require study in larger, broader populations before conclusions about generalizability to other settings can be reached. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02128776
Published reports of extremely preterm birth outcomes provide important information to families, clinicians, and others and are widely used to make clinical and policy decisions. Misreporting or ...misunderstanding of outcome reports may have significant consequences. This article presents 7 recommendations to improve reporting of extremely preterm birth outcomes in both the primary and secondary literature. The recommendations should facilitate clarity in communication about extremely preterm birth outcomes and increase the value of existing and future work in this area.
Objective To evaluate the association between early hypocarbia and 18- to 22-month outcome among neonates with hypoxic-ischemic encephalopathy. Study design Data from the National Institute of Child ...Health and Human Development Neonatal Research Network randomized, controlled trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy were used for this secondary observational study. Infants (n = 204) had multiple blood gases recorded from birth to 12 hours of study intervention (hypothermia versus intensive care alone). The relationship between hypocarbia and outcome (death/disability at 18 to 22 months) was evaluated by unadjusted and adjusted analyses examining minimum PCO2 and cumulative exposure to PCO2 <35 mm Hg. The relationship between cumulative PCO2 <35 mm Hg (calculated as the difference between 35 mm Hg and the sampled PCO2 multiplied by the duration of time spent <35 mm Hg) and outcome was evaluated by level of exposure (none-high) using a multiple logistic regression analysis with adjustments for pH, level of encephalopathy, treatment group (±hypothermia), and time to spontaneous respiration and ventilator days; results were expressed as odds ratios and 95% confidence intervals. Alternative models of CO2 concentration were explored to account for fluctuations in CO2. Results Both minimum PCO2 and cumulative PCO2 <35 mm Hg were associated with poor outcome ( P < .05). Moreover, death/disability increased with greater cumulative exposure to PCO2 <35 mm Hg. Conclusions Hypocarbia is associated with poor outcome after hypoxic-ischemic encephalopathy.
The decision to give intensive care to very preterm infants is often guided by gestational age alone. In this multicenter, prospective study of infants who received such care, female sex, singleton ...birth, higher birth weight, and antenatal corticosteroids were associated with reduced risks similar in magnitude to those associated with a 1-week increase in gestational age.
The decision to give intensive care to very preterm infants is often guided by gestational age alone. In this study of infants who received such care, female sex, singleton birth, higher birth weight, and antenatal corticosteroids were also associated with reduced risks.
Decisions to initiate or forgo intensive care for extremely premature infants are highly controversial.
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In some centers, intensive care is provided to all very premature infants. In most centers, intensive care is provided selectively on the basis of specific gestational-age thresholds. Such care is likely to be routinely administered at 25 weeks' gestation but may be provided only with parental agreement at 23 to 24 weeks, and only “comfort care” may be given at 22 weeks. The evidence base providing support for these decisions is limited,
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and the measurement error in assessing pregnancy length
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may exceed the . . .
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