Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Recruitment status was Recruiting
This is a prospective trial for children with the diagnosis of mild acute pancreatitis admitted to the hospital for continued management. Patients will be enrolled in the study within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled. Demographic, laboratory and imaging data done as standard of care will be collected and additional blood work will be sent as part of the study. Patients will be followed prospectively with regards to tolerance to oral nutrition, pain, length of stay and complications. The hypothesis is that patients that are able to tolerate early oral nutrition will have shorter length of stays and will be similar in terms of pain score ratings, readmission rates, complications and the need for invasive supplemental nutrition. Also patients that are able to tolerate early oral nutrition will have less significant elevation of biochemical markers of pancreatitis severity when compared to patients that do not tolerate early oral nutrition and historical controls.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early Oral Nutrition in Mild Acute Pediatric Pancreatitis|
- Tolerance of Oral Nutrition [ Time Frame: 1 week ] [ Designated as safety issue: No ]The time it takes for the patient to tolerate at least 50% of his/her goal oral calories while maintaining hydration as assessed by urine ouput or fluid intake
- Length of Stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]The length of time between admission for acute pancreatitis and discharge.
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Dietary Supplement: Early Oral Nutrition
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Soma Kumar, MD firstname.lastname@example.org|