Post Discharge Human Milk Fortifier in Preterm Infants

December 30, 2013 updated by: Deborah O'Connor, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2N1
        • The Credit Valley Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Joseph's Health Centre
      • Toronto, Ontario, Canada, M1P 2V5
        • The Scarborough Hospital
      • Toronto, Ontario, Canada, M1E 4B9
        • Rouge Valley Centenary
      • Toronto, Ontario, Canada, M5S 1B2
        • Sunnybrook and Women's Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Deborah L O'Connor, RD, PhD, The Hospital for Sick Children, Toronto Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 19, 2006

First Posted (Estimate)

December 20, 2006

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 30, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000003971

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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