Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

Not Applicable

Terminated

• Conditions: Acute Pediatric Pancreatitis
• Interventions: Dietary Supplement: Early Oral Nutrition

• Registration Number: NCT01423786
• Lead Sponsor: Nationwide Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Primary Completion: 2014-07-16
• Study Completion: 2014-07-16
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Please help	Early Oral Nutrition	Dr. Kumar left Nationwide Children's Hospital in 2014 and efforts to get ahold of her to complete her ct.gov entries have been unsuccessful as we are not able to get ahold of her. In July 2014, she wrote in her Continuing Review application to the NCH IRB: "34 patients have been recruited and data has mostly been collected. Follow up calls have been made and no adverse events occurred during the study period." No other information is available.

Primary Outcome Measures

Name	Time	Method
Tolerance of Oral Nutrition	1 week	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

Secondary Outcome Measures

Name	Time	Method
Length of Stay	1 week	The length of time between admission for acute pancreatitis and discharge.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States