High Energy Formula Feeding in Infants With Congenital Heart Disease

Not Applicable

• Conditions: Growth Failure; Neurodevelopmental Disorder
• Interventions: Dietary Supplement: High energy formula; Dietary Supplement: Standard formula

• Registration Number: NCT01850784
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

Brief Summary

High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Detailed Description

Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-07
• Last Update Submitted: 2013-05-08
• Study First Posted: 2013-05-09
• Last Update Posted: 2013-05-10
• Primary Completion: 2014-02
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• infants >35 weeks of gestational age
• infants with CHD
• İnfants fed with formula feeding

Exclusion Criteria

• Major congenital abnormalities except CHD
• infants could not be fed enterally

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High energy formula	High energy formula	High energy formula (Similac)
Standard formula	Standard formula	Standard formula

Primary Outcome Measures

Name	Time	Method
Weight gain	6 weeks

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental evaluation	18 months	Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months.

Trial Locations

Locations (1)

Sami Ulus CH; 🇹🇷 Ankara, Turkey