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

Tracking Information
First Received Date ^ICMJE	June 8, 2010
Last Updated Date	May 27, 2013
Start Date ^ICMJE	July 2010
Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 8, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01140243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
Official Title ^ICMJE	Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Premature Infants
Intervention ^ICMJE	Dietary Supplement: LCPUFA premature infant formula supplemented with LCPUFA
Study Arm (s)	Experimental: test product Dietary supplement Intervention: Dietary Supplement: LCPUFA Active Comparator: standart Dietary supplement Intervention: Dietary Supplement: LCPUFA
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	31
Completion Date	March 2013
Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	up to 6 Weeks
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01140243
Other Study ID Numbers ^ICMJE	030
Has Data Monitoring Committee	Yes
Responsible Party	Materna Laboratories
Study Sponsor ^ICMJE	Materna Laboratories
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Materna Laboratories
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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