Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

NCT ID: NCT01423786

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pediatric Pancreatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Please help

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.

Group Type OTHER

Early Oral Nutrition

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Early Oral Nutrition

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29031861 (View on PubMed)

Other Identifiers

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277711

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB11-00446

Identifier Type: -

Identifier Source: org_study_id

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