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:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT02274220
Eligibility Criteria:
Inclusion Criteria:
* less than 6 months of age
* weight \> 2.5kg
* surgery using cardiopulmonary bypass
* expected duration of ventilation \> 6 hours
Exclusion Criteria:
* cardiac transplantation
* prematurity (\<37 weeks gestation AND under 28 days of life)
* intrauterine growth restriction
* NEC
* structural gastrointestinal anomalies
* known preoperative feeding intolerance
* diabetes or known metabolic disorder
* preoperative liver or renal dysfunction
* postoperative contraindication to enteral feeding as determined by clinical team
* previous enrollment at an earlier operation
* in the opinion of the clinical or research team the patient is too well to participate, such that slow escalation to feeds would lead to hunger and therefore be considered inappropriate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
6 Months
Study:
NCT02274220
Study Brief:
Protocol Section:
NCT02274220