Post Discharge Human Milk Fortifier in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infant, Low Birth Weight

Intervention / Treatment
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* Drug: Nutrient-enriched human milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nutrient-enriched human milk|nan|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Birth Weight, Fortified Human Milk, breastfeeding, infants, growth