Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

Study Overview
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Brief Summary
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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.

Official Title
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Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

Conditions
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Acute Pediatric Pancreatitis

Intervention / Treatment
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* Dietary Supplement: Early Oral Nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Please help<br>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. | Dietary Supplement: Early Oral Nutrition<br>* Once enrolled in the study, patients will be allowed a oral diet that is low in fat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of Oral Nutrition | 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 | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | The length of time between admission for acute pancreatitis and discharge. | 1 week |