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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02691858
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
68
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hydrocortisone

Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction

Drug: Hydrocortisone
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

    Drug: Saline
    100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
    Other Names:
  • sodium chloride 0.9%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success of Pneumatic Reduction [1 Hour]

      Comparing number of Successful Pneumatic Reductions in both groups

    Secondary Outcome Measures

    1. Reducing number of trials of Pneumatic Reduction [2 Hours]

      Comparing average number of Pneumatic Reduction trials between both groups

    2. Reducing complications [2 Hours]

      Comparing number of complications in both groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 4 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Infantile Intussusception
    Exclusion Criteria:
    • Peritonitis Pneumoperitoneum Morbid patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Pediatric Hospital Cairo Egypt 11432

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahmoud El Fiky, Lecturer of Pediatric Surgery, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02691858
    Other Study ID Numbers:
    • CAIUNIPEDSURG-CR3
    First Posted:
    Feb 25, 2016
    Last Update Posted:
    Jan 14, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Mahmoud El Fiky, Lecturer of Pediatric Surgery, Cairo University
    Intussusception
    Additional relevant MeSH terms:
    Intussusception
    Hydrocortisone
    Hydrocortisone hemisuccinate

    Study Results

    No Results Posted as of Jan 14, 2020