Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Primary Purpose
Acute Pediatric Pancreatitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Oral Nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pediatric Pancreatitis
Eligibility 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
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Please help
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Length of Stay
The length of time between admission for acute pancreatitis and discharge.
Full Information
NCT ID
NCT01423786
First Posted
August 24, 2011
Last Updated
August 5, 2019
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01423786
Brief Title
Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Official Title
Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
Dr. Kumar left Nationwide Children's Hospital. The study expired with the Nationwide Children's Hospital on 7/16/14.
Study Start Date
August 2011 (Actual)
Primary Completion Date
July 16, 2014 (Actual)
Study Completion Date
July 16, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pediatric Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Please help
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Early Oral Nutrition
Intervention Description
Once enrolled in the study, patients will be allowed a oral diet that is low in fat.
Primary Outcome Measure Information:
Title
Tolerance of Oral Nutrition
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Length of Stay
Description
The length of time between admission for acute pancreatitis and discharge.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29031861
Citation
Ellery KM, Kumar S, Crandall W, Gariepy C. The Benefits of Early Oral Nutrition in Mild Acute Pancreatitis. J Pediatr. 2017 Dec;191:164-169. doi: 10.1016/j.jpeds.2017.08.032. Epub 2017 Oct 12.
Results Reference
derived
Learn more about this trial
Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
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