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

Materna Laboratories31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Premature Infants

Interventions

LCPUFADIETARY_SUPPLEMENT

premature infant formula supplemented with LCPUFA

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 6 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Neonatal Intensive Care Unit, Barzilai Medical Center

Ashkelon, Israel

Sharei Zedek MC

Jerusalem, Israel

Outcomes

Primary Outcomes

anthropometric

anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks

Time frame: 12 weeks

Data from ClinicalTrials.gov

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