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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

June 8, 2010
May 27, 2013
July 2010
March 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01140243 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Premature Infants
Dietary Supplement: LCPUFA
premature infant formula supplemented with LCPUFA
  • Experimental: test product
    Dietary supplement
    Intervention: Dietary Supplement: LCPUFA
  • Active Comparator: standart
    Dietary supplement
    Intervention: Dietary Supplement: LCPUFA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
up to 6 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01140243
030
Yes
Materna Laboratories
Materna Laboratories
Not Provided
Not Provided
Materna Laboratories
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP