Post Discharge Human Milk Fortifier in Preterm Infants

Infant, Low Birth Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413985
• Other study ID #: 1000003971
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2006
• Last updated: December 30, 2013
• Start date: January 2004

Study information

• Verified date: December 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Infant, Low Birth Weight

Intervention

Drug:
• Nutrient-enriched human milk

Locations

Country	Name	City	State
Canada	The Credit Valley Hospital	Mississauga	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Rouge Valley Centenary	Toronto	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook and Women's Health Sciences Centre	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	The Scarborough Hospital	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario

Sponsors (2)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth (weight, length and head circumference)			No
Primary	Body composition (fat-free mass, whole body mineral content, fat mass			No
Primary	Milk consumption			No
Primary	Estimated energy and nutrient intakes
Primary	Duration/exclusivity of breastfeeding
Primary	Morbidity (serious adverse events, hospital re-admissions)
Primary	Development (mental, motor, visual and language)