Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

NCT01423786 | Terminated

• 2 other identifiers: IRB11-00446277711
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pediatric Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Length of Stay

  1 week

Study Arms (1)

Please help

OTHER

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

Interventions

Early Oral Nutrition DIETARY_SUPPLEMENT

Once enrolled in the study, patients will be allowed a oral diet that is low in fat.

Please help

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of acute pancreatitis
• Enroll within 24 hours of diagnosis
• At least 50% of baseline diet must be taken orally

You may not qualify if:

• Evidence of severe pancreatitis
• Diagnosis of chronic pancreatitis
• Patients unable to communicate pain or a desire to eat/drink

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 29031861 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 26, 2011
• Study Start: August 1, 2011
• Primary Completion: July 16, 2014
• Study Completion: July 16, 2014
• Last Updated: August 7, 2019

Record last verified: 2011-08

Locations

US (1)