Status:
COMPLETED
Preterm Infant Growth
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Growth
Development
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.
Eligibility Criteria
Inclusion
- Born AGA
- Exclusively formula-fed
- 28-34 weeks GA at birth
- Intact GI tract, tolerating full oral feeds
- Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days
Exclusion
- Severe respiratory disease defined as needing mechanical ventilation at discharge
- Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
- Major congenital malformation, history of GI surgery, severe postnatal complications
- Daily or routine diuretic use at time of discharge
- Receiving more than 10% of daily kcals from food additives such as thickeners
- Currently participating or having participated in another conflicting clinical trial.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01162798
Start Date
September 1 2010
End Date
September 1 2014
Last Update
November 4 2014
Active Locations (9)
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1
Children's Hospital & Research Center
Oakland, California, United States
2
Advocate Lutheran Children's Hospital
Park Ridge, Illinois, United States
3
University of Iowa
Iowa City, Iowa, United States, 52241
4
Center for Human Nutrition
Omaha, Nebraska, United States, 68105