Status:
COMPLETED
Feeding Study - Effects Post-cardiac Surgery
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Heart Disease
Dietary Modification
Eligibility:
All Genders
1-6 years
Phase:
NA
Brief Summary
The purpose of this randomized trial is to clarify the role of enteral nutrition (EN) on the relationship between cardiopulmonary bypass-induced inflammation and insulin resistance by investigating th...
Detailed Description
Good nutrition is important for patients after surgery. Patients who are given food tend to have fewer infections, better wound healing, and are possibly discharged more quickly from the intensive car...
Eligibility Criteria
Inclusion
- less than 6 months of age
- weight \> 2.5kg
- surgery using cardiopulmonary bypass
- expected duration of ventilation \> 6 hours
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT02274220
Start Date
October 1 2014
End Date
April 1 2017
Last Update
May 25 2018
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8