High Energy Formula Feeding in Infants With Congenital Heart Disease

Dr. Sami Ulus Children's Hospital100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

100

Conditions

Growth Failure Neurodevelopmental Disorder

Interventions

High energy formulaDIETARY_SUPPLEMENT

The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)

Standard formulaDIETARY_SUPPLEMENT

The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)

Eligibility

Sex: ALLMin age: 8 DaysMax age: 6 Months

Medical Language ↔ Plain English

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

Locations (1)

Sami Ulus CH

Ankara, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Weight gain

Time frame: 6 weeks

Secondary Outcomes

Neurodevelopmental evaluation

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

Time frame: 18 months

Central Contacts

Dilek Dilli, Assoc Prof

CONTACT

00903126243 dilekdilli2@yahoo.com

Data from ClinicalTrials.gov

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