Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
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|ClinicalTrials.gov Identifier: NCT02691858|
Recruitment Status : Recruiting
First Posted : February 25, 2016
Last Update Posted : January 14, 2020
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|
|Intussusception||Drug: Hydrocortisone Drug: Saline||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
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 Name: 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 Name: sodium chloride 0.9%
- Success of Pneumatic Reduction [ Time Frame: 1 Hour ]Comparing number of Successful Pneumatic Reductions in both groups
- Reducing number of trials of Pneumatic Reduction [ Time Frame: 2 Hours ]Comparing average number of Pneumatic Reduction trials between both groups
- Reducing complications [ Time Frame: 2 Hours ]Comparing number of complications in both groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691858
|Contact: Mostafa Gad, MScemail@example.com|
|Contact: Mahmoud Elfiky, MDfirstname.lastname@example.org|
|Study Chair:||Gamal El Tagy, MD||Cairo University|