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High Energy Formula Feeding in Infants With Congenital Heart Disease

D

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

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

Trial contacts and locations

1

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Central trial contact

Dilek Dilli, Assoc Prof

Data sourced from clinicaltrials.gov

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