Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
Not Applicable
Completed
- Conditions
- Premature Infants
- Interventions
- Dietary Supplement: LCPUFA
- Registration Number
- NCT01140243
- Lead Sponsor
- Materna Laboratories
- 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 Hospital.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description test product LCPUFA Dietary supplement standart LCPUFA Dietary supplement
- Primary Outcome Measures
Name Time Method anthropometric 12 weeks anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Neonatal Intensive Care Unit, Barzilai Medical Center
🇮🇱Ashkelon, Israel
Sharei Zedek MC
🇮🇱Jerusalem, Israel