Home
Search
Study Topics
Glossary
|
|
|
|
|
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 |
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 |
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 |
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) |
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.
Ages Eligible for Study: | up to 4 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Deborah L O'Connor, RD, PhD | The Hospital for Sick Children, Toronto Canada |
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 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Low Birth Weight Fortified Human Milk breastfeeding infants growth |
Body Weight Birth Weight Signs and Symptoms |
Body Weight Birth Weight Signs and Symptoms |