Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital

Not Applicable

Completed

• Conditions: Premature Infants

• 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

Study Timeline

• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Study Start: 2010-07
• Status Verified: 2012-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-05-27
• Last Update Posted: 2013-05-29

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

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

Trial Locations

Locations (2)

Neonatal Intensive Care Unit, Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

Sharei Zedek MC; 🇮🇱 Jerusalem, Israel