NCT01368705

Nitrogen Balance in Infants After Post Cardiothoracic Surgery

Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Not accepted

Summary

The objective is to the amount of protein infants require after cardiopulmonary bypass surgery.

Detailed description

Postoperative neonates are susceptible to the adverse effects of surgery that is characterized by a breakdown of body stores. Without appropriate nutritional consideration this process can lead to increased physiological instability. It has been extensively documented that critically ill patients are typically catabolic. This results in body nitrogen losses from the breakdown of somatic protein to fuel metabolic processes such as, gluconeogenesis. The evaluation of this catabolic response is particularly crucial in infants due to their limited fat and lean body mass reserves. Quantifying the amount of protein needed to maintain body composition and to meet the demands of surgical stress is of clinical importance when considering factors associated with postoperative morbidity, such as delayed wound healing, impaired growth and prolonged hospital stay. The results obtained from this study will assist with determining an appropriate level of protein for the development of optimal nutrition prescriptions that are aimed at reducing catabolism of body stores.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standard protein delivery	Protein delivery of 1.5 g/kg/day.
DIETARY_SUPPLEMENT	Intervention 1 (2.2g/kg/day)	protein delivery of 2.2g/kg/day
DIETARY_SUPPLEMENT	Intervention 2 (3.0 g/kg/day)	protein delivery of 3.0 g/kg/day

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-06-08
• Last updated: 2013-08-19

Locations

1 site across 1 country: Canada