Post Discharge Human Milk Fortifier in Preterm Infants - Full Text View

Sponsors and Collaborators:	The Hospital for Sick Children Canadian Institutes of Health Research (CIHR)
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00413985

Purpose

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.

Condition	Intervention	Phase
Infant, Low Birth Weight	Drug: Nutrient-enriched human milk	Phase II

MedlinePlus related topics: Breast Feeding

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Growth and Development in Preterm Infants Fed Human Milk Containing a Powdered Human Milk Fortifier (HMF) Post Hospital Discharge

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Growth (weight, length and head circumference) [ Designated as safety issue: No ]
Body composition (fat-free mass, whole body mineral content, fat mass [ Designated as safety issue: No ]
Milk consumption [ Designated as safety issue: No ]
Estimated energy and nutrient intakes
Duration/exclusivity of breastfeeding
Morbidity (serious adverse events, hospital re-admissions)
Development (mental, motor, visual and language)

Estimated Enrollment:	40
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 4 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413985

Locations

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

Sponsors and Collaborators

The Hospital for Sick Children

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Deborah L O'Connor, RD, PhD

The Hospital for Sick Children, Toronto Canada

More Information

Publications indexed to this study:

O'Connor DL, Khan S, Weishuhn K, Vaughan J, Jefferies A, Campbell DM, Asztalos E, Feldman M, Rovet J, Westall C, Whyte H; Postdischarge Feeding Study Group. Growth and nutrient intakes of human milk-fed preterm infants provided with extra energy and nutrients after hospital discharge. Pediatrics. 2008 Apr;121(4):766-76.

Responsible Party:	The Hospital for Sick Children ( Deborah O'Connor/Principal Investigator )
Study ID Numbers:	1000003971
Study First Received:	December 19, 2006
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00413985
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

Low Birth Weight
Fortified Human Milk
breastfeeding
infants
growth

Study placed in the following topic categories:

Body Weight
Birth Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on January 14, 2009