Clinical trial NCT00413985: Post Discharge Human Milk Fortifier in Preterm Infants
Official title: Growth and Development in Preterm Infants Fed Human Milk Containing a Powdered Human Milk Fortifier (HMF) Post Hospital Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infant, Low Birth Weight
Keywords: Low Birth Weight
Fortified Human Milk
breastfeeding
infants
growth
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2006-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Growth (weight, length and head circumference)
measure: Body composition (fat-free mass, whole body mineral content, fat mass
measure: Milk consumption
measure: Estimated energy and nutrient intakes
measure: Duration/exclusivity of breastfeeding
measure: Morbidity (serious adverse events, hospital re-admissions)
measure: Development (mental, motor, visual and language)
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: The Credit Valley Hospital
state: Ontario
city: Toronto
country: Canada
facility: Rouge Valley Centenary
state: Ontario
city: Toronto
country: Canada
facility: The Scarborough Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook and Women's Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Deborah L O'Connor, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1542/peds.2007-0054.