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Open AccessRandomized controlled trial of enteral vitamin D supplementation (ViDES) in infants <28 weeks gestational age or <1000 g birth weight: study protocol
Vitamin D is necessary to develop healthy lungs and other organs early in life. Most infants born before 28 weeks’ gestation have low vitamin D levels at birth and a limited intake during the first month. Ente...
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Open AccessUse of term reference infants in assessing the developmental outcome of extremely preterm infants: lessons learned in a multicenter study
Extremely preterm (EP) impairment rates are likely underestimated using the Bayley III norm-based thresholds scores and may be better assessed relative to concurrent healthy term reference (TR) infants born in...
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Open AccessEvaluation of negative binomial and zero-inflated negative binomial models for the analysis of zero-inflated count data: application to the telemedicine for children with medical complexity trial
Two characteristics of commonly used outcomes in medical research are zero inflation and non-negative integers; examples include the number of hospital admissions or emergency department visits, where the majo...
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Open AccessEffect of reduced versus usual lipid emulsion dosing on bilirubin neurotoxicity and neurodevelopmental impairment in extremely preterm infants: study protocol for a randomized controlled trial
Bilirubin neurotoxicity (BN) occurs in premature infants at lower total serum bilirubin levels than term infants and causes neurodevelopmental impairment. Usual dose lipid infusions in preterm infants may incr...
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Open AccessRationale and Design of a Statewide Cohort to examine efficient resource utilization for patients with Intracerebral hemorrhage (EnRICH)
Intracerebral hemorrhage is a devastating disease with no specific treatment modalities. A significant proportion of patients with intracerebral hemorrhage are transferred to large stroke treatment centers, su...
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Open AccessAdvantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial
Decisions to stop randomized trials are often based on traditional P value thresholds and are often unconvincing to clinicians. To familiarize clinical investigators with the application and advantages of Bayesia...
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Article
Open AccessStop** guidelines for an effectiveness trial: what should the protocol specify?
Despite long-standing problems in decisions to stop clinical trials, stop** guidelines are often vague or unspecified in the trial protocol. Clear, well-conceived guidelines are especially important to assis...
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Open AccessComparative effectiveness of antihypertensive treatment for older children with primary hypertension: study protocol for a series of n-of-1 randomized trials
Children are increasingly being diagnosed with primary hypertension. The absence of comparative effectiveness research of antihypertensive medications in children has contributed to considerable differences in...
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Open AccessArterial tortuosity and change with age in young patients with aortopathy
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Apolipoprotein E genotype and outcome in infants with hypoxic–ischemic encephalopathy
Adults with the apolipoprotein E (APOE) gene alleles e4 and e2 are at high risk of poor neurological outcome after brain injury. The e4 allele has been associated with cerebral palsy (CP), and the e2 allele ha...
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Effect of inborn vs. outborn delivery on neurodevelopmental outcomes in infants with hypoxic–ischemic encephalopathy: secondary analyses of the NICHD whole-body cooling trial
The effect of birth location on hypothermia-related outcomes has not been rigorously examined in the literature. In this study, we determined whether birth location had an impact on the benefits of whole-body ...
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Cytokine profiles of preterm neonates with fungal and bacterial sepsis
Information on cytokine profiles in fungal sepsis (FS), an important cause of mortality in extremely low birthweight (ELBW) infants, is lacking. We hypothesized that cytokine profiles in the first 21 d of life...
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The effects of aggressive vs. conservative phototherapy on the brainstem auditory evoked responses of extremely-low-birth-weight infants
This study was a two-center, stratified, parallel-group randomized trial comparing the effects of aggressive vs. conservative phototherapy on brainstem auditory evoked response (BAER) latencies in infants with...
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Does Indomethacin Prophylaxis Benefit Extremely Low Birth Weight Infants? Results of a Placebo-Controlled Multicenter Trial
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Vitamin (Vit.) A Supplementation to Increase Survival without Chronic Lung Disease (CLD) in Extremely Low Birth Weight (ELBW) Infants: A 14-Center Randomized Trial • 1161
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Pattern of Improved Survival and Resource Utilization for Very Low Birth Weight (VLBW) Neonates (501-1500 gm) at Parkland Memorial Hospital Between 1977-1995 † 1275
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Does Seeking Informed Consent for Single or Multiple Studies Compromise Maternal Satisfaction? An Observational Study of Mothers of Very-Low-Birthweight Infants ♦ 166
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How Should Normal Values be Defined and Used for an Abnormal Population? Complexities Highlighted in a Multicenter Trial of Vitamin A Supplementation to Prevent Chronic Lung Disease (CLD) among Extremely Low Birth Weight(ELBW;≤1000 g) Infants 528
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Training Pediatric Residents in Evidence-Based Ethics: An Exploratory Clinical Trial ♦ 161
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Inter-center variation in concerns about ethical research design: Neonatal Network experience with Institutional Review Board (IRB) review.• 159