Post Discharge Human Milk Fortifier in Preterm Infants

The Hospital for Sick Children

Status and phase

Completed

Phase 2

Conditions

Infant, Low Birth Weight

Treatments

Drug: Nutrient-enriched human milk

Study type

Interventional

Funder types

Other

Identifiers

NCT00413985

1000003971

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 day to 4 months old

Volunteers

No Healthy Volunteers

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