Skip to main content
OpenTrials
Completed

NCT Number: NCT01203475

Growth Observational Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Palo Alto, California, United States

Loading trial locations.

About this study

Previous growth curves for premature infants were based on a 1948 study of 100 infants. More recent reports described growth rates for VLBW infants exceeded those predicted by the previous study. The authors suggested that the differences may reflect changes in nutritional management and cautioned that the observed growth rates may not be optimal. Although a greater number of extremely low birth weight infants were included in these studies, data for infants with birth weights <750 g was still limited.

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.

Data were collected on 1660 infants with birth weights between 501 to 1500 g who were inborn or admitted at 24 hours of age or less to 1 of the 12 National Institute of Child Health and Human Development (NICHD) Neonatal Research Network centers between August 31, 1994 and August 9, 1995, survived >7 days (168 hours) and were free of major congenital anomalies. Infants were weighed daily for a minimum of 14 days or until birth weight was regained, whichever occurred later, and then weekly. Recumbent length was measured weekly with a Premie Length Board. Head circumference (HC) was measured weekly. Midarm circumference (MAC) was measured weekly. Length, HC, and MAC measurements were each performed twice.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants with birth weights between 501 to 1500g who were inborn or admitted at 24 hours of age or less
  • Survived >7 days (168 hours)

Exclusion criteria

  • Major congenital anomalies

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Acronym: Growth

Important dates

Study start
1994
Primary completion
1995
Study completion
1995
First posted
Sep 16, 2010
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.