Status:
COMPLETED
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
Lead Sponsor:
Materna Laboratories
Conditions:
Premature Infants
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospi...
Eligibility Criteria
Inclusion
- premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
- whose mothers are unable to breast feed or have chosen not to breast feed,
- Whose parents have signed the informed consent form.
- Only the first among twins will be recorded for the study.
Exclusion
- Chromosomal abnormalities or congenital malformation.
- Metabolic abnormalities.
- Central nervous system abnormalities.
- Severe developmental disorders.
- GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
- Milk allergy or intolerance.
- Growth failure.
- Chronic disease
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01140243
Start Date
July 1 2010
End Date
March 1 2013
Last Update
May 29 2013
Active Locations (2)
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1
Neonatal Intensive Care Unit, Barzilai Medical Center
Ashkelon, Israel
2
Sharei Zedek MC
Jerusalem, Israel