Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT05945459
Eligibility Criteria:
Inclusion Criteria:
* Patient of less than 1 year of age who underwent congenital heart surgery procedure in Harapan Kita National Cardiovascular Center
* Risk adjustment for congenital heart surgery (RACHS) score 2-4
* Patients who do not get exclusive breastfeeding due to any cause
Exclusion Criteria:
* History of prematurity (\<37 weeks gestational age)
* Formula intolerance or cow milk protein allergy
* Lethal chromosome abnormality
* Galactosemia
* Gastrointestinal malformation or obstruction
* Renal failure
* Liver disease
* Metabolic abnormalities
* Need for extracorporeal membrane oxygenation
Drop-out
* Patients who develop diarrhea for more than 5 days during the study period despite getting adequate therapy
* Patients who need prolonged total parenteral nutrition (e.g., gastrointestinal bleeding due to any cause, chylothorax, etc.)
* Patients with necrotizing enterocolitis during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
1 Year
Study:
NCT05945459
Study Brief:
Protocol Section:
NCT05945459