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

May 27, 2013 updated by: Materna Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashkelon, Israel
        • Neonatal Intensive Care Unit, Barzilai Medical Center
      • Jerusalem, Israel
        • Sharei Zedek MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test product
Dietary supplement
Dietary supplement: LCPUFA
premature infant formula supplemented with LCPUFA
Active Comparator: standart
Dietary supplement
Dietary supplement: LCPUFA
premature infant formula supplemented with LCPUFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anthropometric
Time Frame: 12 weeks
anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Materna Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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