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

Premature Infants Clinical Trial

Official title:

Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140243
• Other study ID #: 030
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: May 27, 2013
• Start date: July 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2012
• Source: Materna Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Premature Infants

Intervention

Dietary Supplement:
• LCPUFA
premature infant formula supplemented with LCPUFA

Locations

Country	Name	City	State
Israel	Neonatal Intensive Care Unit, Barzilai Medical Center	Ashkelon
Israel	Sharei Zedek MC	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Materna Laboratories

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anthropometric	anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks	12 weeks	Yes