Status:
COMPLETED
Post Discharge Human Milk Fortifier in Preterm Infants
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Infant, Low Birth Weight
Eligibility:
All Genders
1-4 years
Phase:
PHASE2
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 d...
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 evidenc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00413985
Start Date
January 1 2004
Last Update
December 31 2013
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
The Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
2
Rouge Valley Centenary
Toronto, Ontario, Canada, M1E 4B9
3
The Scarborough Hospital
Toronto, Ontario, Canada, M1P 2V5
4
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7