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RecruitingNCT02691858Updated Aug 27, 2024

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

An interventional study of Hydrocortisone and Saline in Intussusception, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 3 Months to 4 Years. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled Apr 2015, registered Feb 2016).
  • Started Apr 2015; still recruiting 11 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
3 Months to 4 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intussusception

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Keywords

  • Intussusception
03

In context

Intussusception

31 studies on the registry are indexed under Intussusception; 6 are open to participants now.

This study's planned enrollment of 80 is close to the median of 78 across 16 interventional studies indexed under Intussusception.

Browse Intussusception studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 4 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infantile Intussusception

Exclusion criteria

Exclusion Criteria:

  • Peritonitis Pneumoperitoneum Morbid patients
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Hydrocortisone

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

    Drug: Hydrocortisone

  • Placebo comparator
    Saline

    Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction

    Drug: Saline

Interventions

  • 10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction

    Also known as: Solu-Cortef

  • DrugSaline

    100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction

    Also known as: sodium chloride 0.9%

06

What researchers measure

Primary outcomes

  1. Success of Pneumatic Reduction

    Comparing number of Successful Pneumatic Reductions in both groups

    Time frame: 1 Hour

Secondary outcomes

  1. Reducing number of trials of Pneumatic Reduction

    Comparing average number of Pneumatic Reduction trials between both groups

    Time frame: 2 Hours

  2. Reducing complications

    Comparing number of complications in both groups

    Time frame: 2 Hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

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

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02691858
Lead sponsor
Cairo University
Responsible party
Mahmoud El Fiky (Lecturer of Pediatric Surgery, Cairo University) — Principal investigator
First posted
Feb 25, 2016
Start date
Apr 2015
Primary completion
Jun 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 27, 2024

Study contacts

Mostafa Gad, MSc
Contact
mostafagad@kasralainy.edu.eg
201002265009
Mahmoud Elfiky, MD
Contact
mfiky@kasralainy.edu.eg
201001557755
Gamal El Tagy, MD
study chair · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Hydrocortisone

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