Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas

Phase 4

Terminated

• Conditions: Premature Birth of Newborn
• Interventions: Other: Post discharge formula

• Registration Number: NCT01759134
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

Detailed Description

Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.

Study Timeline

• Study First Submitted: 2012-01-02
• Status Verified: 2012-12
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-01
• Study First Posted: 2013-01-02
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-25
• Primary Completion: 2014-01
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
2. Gestational week 30-34.

Exclusion Criteria

1. Congenital major malformation (e.g. congenital heart disease).
2. Chromosomal abnormality (e.g. Down's syndrome)
3. Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
4. Milk allergy
5. Chronic disease (e.g. oxygen treatment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post Discharge Formula	Post discharge formula	Babies will be given formula for first three months post discharge

Primary Outcome Measures

Name	Time	Method
growth	3 months post discharge	weight (kg), length (cm), head circumference (cm).

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel