Back to resultsInfant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
Primary Purpose
Premature Infants
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
LCPUFA
Sponsored by
About this trial
This is an interventional treatment trial for Premature Infants focused on measuring fat formulation
Eligibility 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
Sites / Locations
- Neonatal Intensive Care Unit, Barzilai Medical Center
- Sharei Zedek MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
test product
standart
Arm Description
Dietary supplement
Dietary supplement
Outcomes
Primary Outcome Measures
anthropometric
anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01140243
Brief Title
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Materna Laboratories
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants
Keywords
fat formulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test product
Arm Type
Experimental
Arm Description
Dietary supplement
Arm Title
standart
Arm Type
Active Comparator
Arm Description
Dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
LCPUFA
Intervention Description
premature infant formula supplemented with LCPUFA
Primary Outcome Measure Information:
Title
anthropometric
Description
anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
6 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Neonatal Intensive Care Unit, Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Sharei Zedek MC
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
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