Growth Failure, Neurodevelopmental Disorder
Conditions
Keywords
Congenital heart disease, Growth,Neurodevelopment
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
Interventions
DIETARY_SUPPLEMENTHigh energy formula
The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)
DIETARY_SUPPLEMENTStandard formula
The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)
Sponsors
Dr. Sami Ulus Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Days to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurodevelopmental evaluation | 18 months | Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactDilek Dilli, Assoc Prof
Outcome results
None listed