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Completed

NCT Number: NCT00413985

Post Discharge Human Milk Fortifier in Preterm Infants

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.

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Key information

Age range

1 day–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Credit Valley Hospital, Mississauga, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrient-enriched human milk

Drug

Primary outcomes

  1. Growth (weight, length and head circumference)

  2. Body composition (fat-free mass, whole body mineral content, fat mass

  3. Milk consumption

  4. Estimated energy and nutrient intakes

  5. Duration/exclusivity of breastfeeding

  6. Morbidity (serious adverse events, hospital re-admissions)

  7. Development (mental, motor, visual and language)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
First posted
Dec 20, 2006
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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