Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

Acute Pediatric Pancreatitis Clinical Trial

Official title:

Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01423786
• Other study ID #: IRB11-00446
• Secondary ID: 277711
• Status: Terminated
• Phase: N/A
• Start date: August 2011
• Est. completion date: July 16, 2014

Study information

• Verified date: August 2011
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: July 16, 2014
• Est. primary completion date: July 16, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pediatric Pancreatitis
• Pancreatitis

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Stay	The length of time between admission for acute pancreatitis and discharge.	1 week