IntussusceptionNCT02691858
Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
A study testing Hydrocortisone and Saline in people with Intussusception, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 4 years
- Conditions the study is for
- Intussusception
- What is being tested?
- Hydrocortisone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infantile Intussusception
Who cannot join
- Peritonitis Pneumoperitoneum Morbid patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Pediatric Hospital
Cairo, 11432
Mahmoud Elfiky, MD, mfiky@kasralainy.edu.eg
Mostafa Gad, MD, mostafagad@kasralainy.edu.eg
About this study
Official title: 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.
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.
- Conditions
- Intussusception
- Being tested
- Hydrocortisone, Saline
- Keywords
- Intussusception
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Solu-Cortef
10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
SalineDrug
Also called sodium chloride 0.9%
100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Experimental | Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction Receives: Drug: Hydrocortisone |
| Saline | Placebo comparator | Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Pneumatic Reduction
Comparing number of Successful Pneumatic Reductions in both groups
Measured: 1 Hour
Secondary outcomes (2)
Reducing number of trials of Pneumatic Reduction
Comparing average number of Pneumatic Reduction trials between both groups
Measured: 2 Hours
Reducing complications
Comparing number of complications in both groups
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IntussusceptionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud El Fiky, Cairo University
- Investigators
- Gamal El Tagy, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691858
- Sponsor's protocol ID
- CAIUNIPEDSURG-CR3
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2016
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gersema, Lisa, and Karen Baker.
Kara, Cüneyt Orhan, and Inci Gökalan.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02691858
- Acronym / sponsor ID
- CAIUNIPEDSURG-CR3
- Conditions
- Intussusception
- Keywords
- Intussusception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Experimental | Drug: HydrocortisoneHydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction |
| Saline | Placebo comparator | Drug: SalineSaline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction |
Who may qualify
- Ages
- 3 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infantile Intussusception
Key exclusion criteria (1 listed)
- Peritonitis Pneumoperitoneum Morbid patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: Solu-Cortef10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction | Drug | Hydrocortisone |
| SalineAlso: sodium chloride 0.9%100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction | Drug | Saline |
Primary outcome
Success of Pneumatic Reduction
Time frame: 1 Hour
Comparing number of Successful Pneumatic Reductions in both groups
2 secondary outcomes
Reducing number of trials of Pneumatic Reduction
Time frame: 2 Hours
Reducing complications
Time frame: 2 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- BackgroundGersema, Lisa, and Karen Baker.
- Results publicationKara, Cüneyt Orhan, and Inci Gökalan.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal El Tagy, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone and Saline in people with Intussusception, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Gad, MSc (201002265009, mostafagad@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Pneumatic Reduction (time frame: 1 Hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02691858, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.