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

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ClinicalTrials.gov Identifier: NCT01140243
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Materna Laboratories

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Premature Infants Dietary Supplement: LCPUFA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : July 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. anthropometric [ Time Frame: 12 weeks ]
    anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Weeks   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140243


Locations
Israel
Neonatal Intensive Care Unit, Barzilai Medical Center
Ashkelon, Israel
Sharei Zedek MC
Jerusalem, Israel
Sponsors and Collaborators
Materna Laboratories
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Materna Laboratories
ClinicalTrials.gov Identifier: NCT01140243     History of Changes
Other Study ID Numbers: 030
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: April 2012

Keywords provided by Materna Laboratories:
fat formulation

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