Post Discharge Human Milk Fortifier in Preterm Infants
This study has been completed.
Sponsor:
The Hospital for Sick Children
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00413985
First received: December 19, 2006
Last updated: December 24, 2008
Last verified: December 2008
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Growth and Development in Preterm Infants Fed Human Milk Containing a Powdered Human Milk Fortifier (HMF) Post Hospital Discharge |
Resource links provided by NLM:
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 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
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 Credit Valley Hospital | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| 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 | |
| Sunnybrook and Women's Health Sciences Centre | |
| Toronto, Ontario, Canada, M5S 1B2 | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| The Scarborough Hospital | |
| Toronto, Ontario, Canada, M1P 2V5 | |
| Rouge Valley Centenary | |
| Toronto, Ontario, Canada, M1E 4B9 | |
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
No publications provided by The Hospital for Sick Children
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Deborah O'Connor/Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00413985 History of Changes |
| Other Study ID Numbers: | 1000003971 |
| Study First Received: | December 19, 2006 |
| Last Updated: | December 24, 2008 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by The Hospital for Sick Children:
|
Low Birth Weight Fortified Human Milk breastfeeding infants growth |
Additional relevant MeSH terms:
|
Birth Weight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013