CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,660 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01203475
NCT01203475N/ACompleted

Growth Observational Study

NICHD Neonatal Research Network·observational·Posted Sep 16, 2010·Updated Jun 8, 2015

In Brief

An observational study for Infant, Newborn and 3 related conditions. Completed, enrolled 1,660 participants across 13 sites.

Detailed Summary

This study was a multicenter, prospective cohort study to define postnatal longitudinal growth for very low birth weight (VLBW) infants. The objectives were: 1) to develop postnatal growth curves for VLBW preterm infants that would permit an assessment of growth velocity; 2) to relate growth velocity and nutritional practices (duration of parenteral nutrition, age at first enteral feeding, and age at full enteral feeding); 3) to compare growth velocity in infants who are small-for-gestational age (SGA) with infants who are appropriate-for-gestational age (AGA); and 4) to relate growth velocity to several common, major morbidities, including chronic lung disease (CLD), nosocomial infection (or late-onset infection) and necrotizing enterocolitis (NEC). These growth data may be useful in identifying preterm infants who are growing slowly despite current nutritional support and in designing and performing clinical trials of nutritional interventions.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2010
Enrollment StartAug 1, 1994
Primary CompletionAug 1, 1995
TodayJul 1, 2026
Enrollment to primary: 1 yearPosted 15.8 years ago