Nitrogen Balance in Infants After Post Cardiothoracic Surgery
|Congenital Heart Disease||Dietary Supplement: Standard protein delivery Dietary Supplement: Intervention 1 (2.2g/kg/day) Dietary Supplement: Intervention 2 (3.0 g/kg/day)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery|
- Nitrogen Balance [ Time Frame: From 0-84 hours ]After an initial adaptation period of approximately 12 hours receiving parenteral nutrition the first 24-hour urine collection for nitrogen balance will be started; following this two successive 24-hour urine collections will be performed in order to obtain a three-day collection for nitrogen balance analyses.
|Study Start Date:||August 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Control Group||
Dietary Supplement: Standard protein delivery
Protein delivery of 1.5 g/kg/day.
|Experimental: Intervention Group 1||
Dietary Supplement: Intervention 1 (2.2g/kg/day)
protein delivery of 2.2g/kg/day
|Experimental: Intervention Group 2||
Dietary Supplement: Intervention 2 (3.0 g/kg/day)
protein delivery of 3.0 g/kg/day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368705
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5V 1B2|
|Principal Investigator:||Paul B Pencharz, MD||The Hospital for Sick Children, Toronto, Canada|