The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants

Completed

• Conditions: Premature Birth of Newborn; Malnutrition; Intrauterine or Fetal, Small-for-dates

• Registration Number: NCT01881256
• Lead Sponsor: University College Cork

Brief Summary

This is a longitudinal, observational study on nutrition, growth and body composition in preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm period by investigating associations between macronutrient supply, growth, and body composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.

Detailed Description

Infants between 23 and 24 weeks gestation and with a birth weight of 500 to 1500 g are recruited to a longitudinal, observational study of nutrition, growth and body composition in Cork University Maternity Hospital, Ireland.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-06
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-18
• Last Update Submitted: 2013-06-18
• Study First Posted: 2013-06-19
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Babies with a birth weight ≤1.5kg and gestational age ≤34 weeks were considered eligible.

Exclusion Criteria

• presence of congenital abnormalities or conditions that interfere with growth or body composition (congenital diseases, chromosomal abnormalities, chronic lung disease, cardiac or gastrointestinal diseases).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Actual nutrient intake vs recommended nutrient requirements in preterm infants	19 months	Comparison of intake with requirements during the preterm infant's hospital stay and up to 2 months corrected gestational age.

Secondary Outcome Measures

Name	Time	Method
Longitudinal data on body composition in Irish preterm neonates	19 months	Evaluation of appropriateness of current feeding regimens for achievement of optimal growth \& body composition outcomes
Longitudinal data on vitamin D intake and circulating 25(OH)D	19 months	To examine the relationship between vitamin D intake and serum 25-hydroxyvitamin D concentrations and biomarkers of calcium handling by analysis of sequential serum samples.