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NCT01850784 Clinical Trial

High Energy Formula Feeding in Infants With Congenital Heart Disease

Growth Failure Clinical Trial

Official title:
High Energy Formula Feeding in Infants With Congenital Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01850784
Other study ID # 132/2013
Secondary ID
Status Recruiting
Phase N/A
First received May 7, 2013
Last updated May 8, 2013
Start date February 2013
Est. completion date October 2014

Study information
Verified date May 2013
Source Dr. Sami Ulus Children's Hospital
Contact Dilek Dilli, Assoc Prof
Phone 00903126243
Email dilekdilli2@yahoo.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date October 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- infants >35 weeks of gestational age

- infants with CHD

- Infants fed with formula feeding

Exclusion Criteria:

- Major congenital abnormalities except CHD

- infants could not be fed enterally

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• High energy formula
The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)
• Standard formula
The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)

Locations
Country Name City State
Turkey Sami Ulus CH Ankara

Sponsors (1)
Lead Sponsor Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight gain 6 weeks No
Secondary Neurodevelopmental evaluation Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months. 18 months No
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