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

This study is currently recruiting participants.
Verified May 2012 by Materna Laboratories
Sponsor:
Information provided by (Responsible Party):
Materna Laboratories
ClinicalTrials.gov Identifier:
NCT01140243
First received: June 8, 2010
Last updated: April 23, 2013
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Premature Infants
 Dietary Supplement: LCPUFA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Materna Laboratories:

Primary Outcome Measures:
  • anthropometric [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 6 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140243

Locations
Israel
Neonatal Intensive Care Unit, Barzilai Medical Center Recruiting
Ashkelon, Israel
Contact: Shmuel Zangen, MD     08-6745013/4/5     szangen@barzi.health.gov.il    
Sharei Zedek MC Recruiting
Jerusalem, Israel
Contact: Cathy Hamerman, Prof.         cathy@cc.huji.ac.il    
Principal Investigator: Cathy Hamerman, Prof            
Sponsors and Collaborators
Materna Laboratories
  More Information

No publications provided

Responsible Party: Materna Laboratories
ClinicalTrials.gov Identifier: NCT01140243     History of Changes
Other Study ID Numbers: 030
Study First Received: June 8, 2010
Last Updated: April 23, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Materna Laboratories:
fat formulation

ClinicalTrials.gov processed this record on May 23, 2013