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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Premature Infants | Dietary Supplement: LCPUFA | Not Applicable |
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 |
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
|
- anthropometric [ Time Frame: 12 weeks ]anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks

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Ages Eligible for Study: | up to 6 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Israel | |
Neonatal Intensive Care Unit, Barzilai Medical Center | |
Ashkelon, Israel | |
Sharei Zedek MC | |
Jerusalem, Israel |
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 |