Back to resultsEffect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
Primary Purpose
Intussusception
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hydrocortisone
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Intussusception focused on measuring Intussusception
Eligibility Criteria
Inclusion Criteria:
- Infantile Intussusception
Exclusion Criteria:
- Peritonitis Pneumoperitoneum Morbid patients
Sites / Locations
- Cairo University Pediatric HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrocortisone
Saline
Arm Description
Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
Outcomes
Primary Outcome Measures
Success of Pneumatic Reduction
Comparing number of Successful Pneumatic Reductions in both groups
Secondary Outcome Measures
Reducing number of trials of Pneumatic Reduction
Comparing average number of Pneumatic Reduction trials between both groups
Reducing complications
Comparing number of complications in both groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02691858
Brief Title
Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
Official Title
Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intussusception
Keywords
Intussusception
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrocortisone
Arm Type
Experimental
Arm Description
Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
Solu-Cortef
Intervention Description
10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
sodium chloride 0.9%
Intervention Description
100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
Primary Outcome Measure Information:
Title
Success of Pneumatic Reduction
Description
Comparing number of Successful Pneumatic Reductions in both groups
Time Frame
1 Hour
Secondary Outcome Measure Information:
Title
Reducing number of trials of Pneumatic Reduction
Description
Comparing average number of Pneumatic Reduction trials between both groups
Time Frame
2 Hours
Title
Reducing complications
Description
Comparing number of complications in both groups
Time Frame
2 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infantile Intussusception
Exclusion Criteria:
Peritonitis Pneumoperitoneum Morbid patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Gad, MSc
Phone
201002265009
Email
mostafagad@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Elfiky, MD
Phone
201001557755
Email
mfiky@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal El Tagy, MD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University Pediatric Hospital
City
Cairo
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Elfiky, MD
Email
mfiky@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Mostafa Gad, MD
Email
mostafagad@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Mostafa Gad, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
Gersema, Lisa, and Karen Baker.
Results Reference
background
Citation
Kara, Cüneyt Orhan, and Inci Gökalan.
Results Reference
result
Learn more about this trial
Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
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