Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

Nationwide Children's Hospital

Status: Terminated

Conditions: Acute Pediatric Pancreatitis

Treatments: Dietary Supplement: Early Oral Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01423786

277711 (Other Grant/Funding Number)

IRB11-00446

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Please help

Other group

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.

Treatment:

Dietary Supplement: Early Oral Nutrition