High Energy Formula Feeding in Infants With Congenital Heart Disease

Dr. Sami Ulus Children's Hospital

Status: Unknown

Conditions: Growth Failure; Neurodevelopmental Disorder

Treatments: Dietary Supplement: High energy formula; Dietary Supplement: Standard formula

Study type: Interventional

Funder types: Other

Identifiers

NCT01850784

132/2013

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 8 days to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

High energy formula

Active Comparator group

Description:

High energy formula (Similac)

Treatment:

Dietary Supplement: High energy formula

Standard formula

Active Comparator group

Description:

Standard formula

Treatment:

Dietary Supplement: Standard formula