Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception

January 13, 2020 updated by: Mahmoud El Fiky, Cairo University

Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial

Intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. Treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception.

Our surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Experimental group will be given single dose IV Hydrocortisone 10 mg/kg with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

Control group will be given Saline 100 ml IV single injection with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Cairo, Egypt, 11432
        • Recruiting
        • Cairo University Pediatric Hospital
        • Principal Investigator:
          • Mostafa Gad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infantile Intussusception

Exclusion Criteria:

  • Peritonitis Pneumoperitoneum Morbid patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydrocortisone
Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
Other Names:
  • Solu-Cortef
PLACEBO_COMPARATOR: Saline
Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
Other Names:
  • sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of Pneumatic Reduction
Time Frame: 1 Hour
Comparing number of Successful Pneumatic Reductions in both groups
1 Hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing number of trials of Pneumatic Reduction
Time Frame: 2 Hours
Comparing average number of Pneumatic Reduction trials between both groups
2 Hours
Reducing complications
Time Frame: 2 Hours
Comparing number of complications in both groups
2 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Gamal El Tagy, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Gersema, Lisa, and Karen Baker.
  • Kara, Cüneyt Orhan, and Inci Gökalan.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (ESTIMATE)

February 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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