NCT07087782

✓ Unanimous Initial: cardiac Requery: cardiac — The study targets infants with single ventricle physiology, a specific pediatric cardiac condition, focusing on nutritional support post-cardiac surgery. Thinking: cardiac — Study population is infants with single-ventricle congenital heart disease, a specific advanced cardiac condition.

✓ Unanimous Initial: cardiac Requery: N/A — The study focuses on pediatric patients with single ventricle physiology (a congenital heart condition), which does not fit the specific non-cancer categories provided for adult populations.

✓ Unanimous Initial: N/A Requery: cardiac — This study focuses on infants with single ventricle physiology (a congenital heart condition) undergoing staged surgical palliation, which is a specific cardiac/cardiovascular condition. Thinking: cardiac — Study focuses on infants with single ventricle physiology undergoing cardiac surgical palliation, which is advanced cardiac disease.

✓ Unanimous Initial: inpatient Requery: outpatient — The intervention (feeding with Fortini or standard formulas) is applied after babies are discharged from the hospital, indicating an outpatient setting.

✓ Unanimous Initial: outpatient Requery: outpatient — The intervention (Fortini formula) is delivered at home after hospital discharge, and the outcomes are measured during the interstage period before the next surgery.

✓ Unanimous Initial: mixed Requery: outpatient — The intervention (Fortini formula feeding) is delivered at home after hospital discharge, with infants followed for 4-6 months in the community until their next surgery.

✓ Unanimous Initial: no Requery: no — The trial tests a nutritional intervention (the Fortini formula) rather than palliative care itself.

✓ Unanimous Initial: yes Requery: no — The intervention is a nutritional formula (Fortini) being tested for growth outcomes, not a palliative care service, despite the surgical procedure being labeled as 'palliation' and the primary purpose being supportive care.

✓ Unanimous Initial: no Requery: no — This study tests a specific nutritional intervention (Fortini formula vs standard formula) in infants with heart conditions, not palliative care consultation or service delivery.

✓ Unanimous Initial: yes Requery: yes — The study monitors hospital readmissions, which are related to healthcare utilization and cost analysis. Thinking: yes — Secondary outcomes include the number of unplanned hospital readmissions, a recognized proxy for healthcare utilization costs.

✓ Unanimous Initial: no Requery: no — The trial tracks hospital readmissions as a clinical outcome but does not assess healthcare utilization, cost analysis, or cost-effectiveness.

✓ Unanimous Initial: yes Requery: yes — The study measures hospital readmissions and prolonged hospitalization as outcomes, which are established cost-effectiveness measures in healthcare economic evaluation. Thinking: yes — Secondary outcome 2.3 measures hospital readmissions, which serves as a cost proxy for healthcare utilization.