Status:
TERMINATED
Impact of Early Enteral Feeding on Splanchnic Blood Flow After Surgery for Critical Heart Disease in the Newborn
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE2
Brief Summary
The objective of this study is to determine the impact of early post-operative feeding on splanchnic blood flow, cardiac output and end organ perfusion, and the patients overall clinical outcomes.
Detailed Description
Neonates with critical congenital heart disease (CHD) undergoing surgery often have postoperative decreases in cardiac output. These hemodynamic changes can result in varying levels of organ dysfuncti...
Eligibility Criteria
Inclusion
- neonates ≤ 30 days of postnatal age at time of operation
- birthweight \> 2.5 kg
- gestational age at birth ≥ 35 weeks
- Patients requiring cardiac surgery who are expected to remain intubated in the CCIU for \> 48 hours
- informed consent by parent or guardian
- approval by treating critical care staff physician
Exclusion
- patients with heterotaxy or pre-existing renal or abdominal pathology (eg. preoperative diagnosis of NEC).
- need for ECMO after repair within the study period (data up to that point will be recorded and analyzed).
- Parent refusal of formula for purposes of study
- Patient on vasopressin or norepinephrine infusion
- Parent or legal guardian refuse consent
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00919945
Start Date
January 1 2009
End Date
July 1 2014
Last Update
May 13 2014
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8