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Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

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ClinicalTrials.gov Identifier: NCT01423786
Recruitment Status : Unknown
Verified August 2011 by Soma Kumar, Nationwide Children's Hospital.
Recruitment status was:  Recruiting
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
Sponsor:
Information provided by (Responsible Party):
Soma Kumar, 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.

Condition or disease Intervention/treatment Phase
Acute Pediatric Pancreatitis Dietary Supplement: Early Oral Nutrition Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Study Start Date : August 2011
Estimated Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources


Intervention Details:
    Dietary Supplement: Early Oral Nutrition
    Once enrolled in the study, patients will be allowed a oral diet that is low in fat.


Primary Outcome Measures :
  1. Tolerance of Oral Nutrition [ Time Frame: 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 :
  1. Length of Stay [ Time Frame: 1 week ]
    The length of time between admission for acute pancreatitis and discharge.



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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423786


Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Soma Kumar, MD       soma.kumar@nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soma Kumar, Pediatric Gastroenterology Fellow, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01423786     History of Changes
Other Study ID Numbers: IRB11-00446
277711 ( Other Grant/Funding Number: The Research Institute at Nationwide Children's Hospital )
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases