Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Nationwide Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Soma Kumar, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01423786
First received: August 24, 2011
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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 Intervention
Acute Pediatric Pancreatitis
Dietary Supplement: Early Oral Nutrition

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Tolerance of Oral Nutrition [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The length of time between admission for acute pancreatitis and discharge.


Estimated Enrollment: 35
Study Start Date: August 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Early Oral Nutrition
    Once enrolled in the study, patients will be allowed a oral diet that is low in fat.
  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 24, 2011
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014