Evaluation of a Novel Human Milk Fortifier in Preterm Infants
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | August 2011 |
| End Date: | October 2012 |
| Contact: | Sue Monnin, MS |
| Email: | suzanne.monnin@abbott.com |
| Phone: | 614-624-3975 |
The purpose of this study is to assess growth of preterm infants fed human milk supplemented
with an experimental human milk fortifier.
Inclusion Criteria:
- 700-1500g birth weight
- 33 weeks or less gestational age
- Appropriate for gestational age
- Initiate enteral feeds of human milk by 21 days of life
- Mother provided exclusive human milk feeds
- Parents allow both human milk and study human milk fortifier
- Singleton or twin birth
Exclusion Criteria:
- Feeding preterm infant formula or non-study human milk fortifier
- Expected at facility less than 15 days
- Congenital anomalies/disease affecting growth and development
- 5 minute APGAR of 4 or less
- Steroid use
- ECMO
- Grade III or IV PVH/IVH
- Mechanical ventilator dependency
- Maternal incapacity
- History of major surgery
- Asphyxia
- Confirmed NEC or sepsis
- Use of probiotics
We found this trial at
15
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of Utah Research is a major component in the life of the U benefiting...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Cleveland, Ohio 44106
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Wesley Medical Center Welcome to one of the most experienced and comprehensive medical centers in...
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