Feeding Study - Effects Post-cardiac Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02274220
• Date of registration: 20/10/2014
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children
• Public title: Feeding Study - Effects Post-cardiac Surgery
• Scientific title: Randomized Study of Early Nutritional Delivery on Glucose Control, Insulin Resistance and Systemic Inflammation Following Pediatric Cardiac Surgery
• Date of first enrolment: October 2014
• Target sample size: 86
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02274220
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Steve Schwartz, MD
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 6 Months
Gender: All

Health Condition(s) or Problem(s) studied

Dietary Modification

Heart Disease

Insulin Resistance

Intervention(s)

Dietary Supplement: Standard advancement of feeds

Dietary Supplement: Rapid advancement of feeds

Primary Outcome(s)

Insulin resistance [Time Frame: 96 hours]

Secondary Outcome(s)

Cardiac output [Time Frame: 96 hours]

Postoperative systemic inflammation [Time Frame: 96 hours]

Number of subjects achieving goal feeds [Time Frame: 96 hours]

Number of subjects with NEC/feeding intolerance/protocol violations [Time Frame: 96 hours]

Morbidity score [Time Frame: 96 hours]

Secondary ID(s)

1000046036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors