Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital

NCT ID: NCT01140243

Last Updated: 2013-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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test product

Dietary supplement

Group Type EXPERIMENTAL

LCPUFA

Intervention Type DIETARY_SUPPLEMENT

premature infant formula supplemented with LCPUFA

standart

Dietary supplement

Group Type ACTIVE_COMPARATOR

LCPUFA

Intervention Type DIETARY_SUPPLEMENT

premature infant formula supplemented with LCPUFA

Interventions

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LCPUFA

premature infant formula supplemented with LCPUFA

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Materna Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neonatal Intensive Care Unit, Barzilai Medical Center

Ashkelon, , Israel

Site Status

Sharei Zedek MC

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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030

Identifier Type: -

Identifier Source: org_study_id

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