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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Materna Laboratories
ClinicalTrials.gov Identifier:
NCT01140243
First received: June 8, 2010
Last updated: May 27, 2013
Last verified: April 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
Enrollment: 31
Study Start Date: July 2010
Study Completion Date: March 2013
Primary Completion Date: March 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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Israel
Neonatal Intensive Care Unit, Barzilai Medical Center
Ashkelon, Israel
Sharei Zedek MC
Jerusalem, Israel
Sponsors and Collaborators
Materna Laboratories
  More Information

Responsible Party: Materna Laboratories
ClinicalTrials.gov Identifier: NCT01140243     History of Changes
Other Study ID Numbers: 030 
Study First Received: June 8, 2010
Last Updated: May 27, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Materna Laboratories:
fat formulation

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 28, 2016