Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Information source: Nationwide Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pediatric Pancreatitis
Intervention: Early Oral Nutrition (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: Nationwide Children's Hospital
Summary
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.
Clinical Details
Official title: Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Tolerance of Oral Nutrition
Secondary outcome: Length of Stay
Eligibility
Minimum age: 2 Years.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of acute pancreatitis
- Enroll within 24 hours of diagnosis
- At least 50% of baseline diet must be taken orally
Exclusion Criteria:
- Evidence of severe pancreatitis
- Diagnosis of chronic pancreatitis
- Patients unable to communicate pain or a desire to eat/drink
Locations and Contacts
Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting Soma Kumar, MD, Email: soma.kumar@nationwidechildrens.org
Additional Information
Starting date: August 2011
Last updated: August 25, 2011
|