Post Discharge Human Milk Fortifier in Preterm Infants

Phase 2

Completed

• Conditions: Infant, Low Birth Weight

• Registration Number: NCT00413985
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Primary Completion: 2007-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-30
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Birth Weight between 750-1800 g
• Gestational Age at birth between 26 and 32 weeks
• Singleton or twin birth (for twins to be eligible, both must meet eligibility criteria)
• Small for Gestational age or appropriate for gestational age
• ≥ 80% energy received from human milk in the previous three days
• ≥ 25% of human milk consumed orally in the previous three days
• Mother agrees to exclusively feed her infant human nilk after discharge
• If so randomized, parents agree to supplement ~1/2 or the human milk provided to her infant as powdered human milk fortifier for 12 weeks after hospital discharge
• Subject's parents have voluntarily signed an informed consent form

Exclusion Criteria

• Serious congenital or chromosomal anomalies that will affect growth
• Grade III or IV periventricular/intraventricular hemorrhage
• Received steroids within 14 days o randomization
• Asphyxia (hypoxia or ischemia) es evident by severe and permanent neurological data
• Maternal incapacity, including maternal cocaine or alcohol abuse dring pregnancy, or concurrent, or mother or infant has tested positive for HIV
• Principal residence of study family outside GTA
• Mother unable to verbally communicate in English
• A single feeding must be fortified > 24 kcal/oz or >50% of feeds need to be fortified

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Milk consumption
Body composition (fat-free mass, whole body mineral content, fat mass
Duration/exclusivity of breastfeeding
Morbidity (serious adverse events, hospital re-admissions)
Growth (weight, length and head circumference)
Development (mental, motor, visual and language)
Estimated energy and nutrient intakes

Trial Locations

Locations (9)

The Credit Valley Hospital; 🇨🇦 Mississauga, Ontario, Canada

Rouge Valley Centenary; 🇨🇦 Toronto, Ontario, Canada

The Scarborough Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto East General Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook and Women's Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Health Centre; 🇨🇦 Toronto, Ontario, Canada