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 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

Resource links provided by NLM:

MedlinePlus related topics: Health Facilities Infant and Newborn Nutrition

U.S. FDA Resources

Further study details as provided by Materna Laboratories:

Primary Outcome Measures:

anthropometric [ Time Frame: 12 weeks ]
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)
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

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

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 August 17, 2017

To Top