Post Discharge Human Milk Fortifier in Preterm Infants

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Canadian Institutes of Health Research (CIHR)

Criteria

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