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

Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01140243

Enrollment

Registered

2010-06-09

Start date

2010-07-31

Completion date

2013-03-31

Last updated

2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infants

Keywords

fat formulation

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.

Interventions

DIETARY_SUPPLEMENTLCPUFA

premature infant formula supplemented with LCPUFA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 6 Weeks

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

Design outcomes

Primary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026