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

Materna Laboratories

Status: Completed

Conditions: Premature Infants

Treatments: Dietary Supplement: LCPUFA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01140243

030

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 2 to 6 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

31 participants in 2 patient groups

test product

Experimental group

Description:

Dietary supplement

Treatment:

Dietary Supplement: LCPUFA

standart

Active Comparator group

Description:

Dietary supplement

Treatment:

Dietary Supplement: LCPUFA