NCT00413985

Post Discharge Human Milk Fortifier in Preterm Infants

Growth and Development in Preterm Infants Fed Human Milk Containing a Powdered Human Milk Fortifier (HMF) Post Hospital Discharge

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Day – 4 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether low birth weight (LBW) infants fed human milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks after hospital discharge will have better growth and neurodevelopment than infants fed HM alone.

Detailed description

Consensus exists in the literature that a significant proportion of low birth weight (LBW, \<1800 g) infants leave hospital with overt signs of under-nutrition (eg. growth retardation). Recent evidence from randomized control trials suggest that provision of nutrient-enriched feeding to formula-fed premature infants after hospital discharge improves their growth, accretion of lean body mass and bone mineral content compared to infants fed a standard term formula. While available data suggest an advantage of human milk feeding after hospital discharge, experimental evidence on which to base guidelines to enrich, or not to enrich, human milk (HM) are notably absent.

Conditions

• Infant, Low Birth Weight

Interventions

Type	Name	Description
DRUG	Nutrient-enriched human milk

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-11-01
• First posted: 2006-12-20
• Last updated: 2013-12-31

Locations

9 sites across 1 country: Canada