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General information
2018-05-22, 1397/03/01
2019-06-22, 1398/04/01
20182019-0506-22 00:00:00
empty
There was a mistake in registering the actual start time of recruitment.
There was a mistake in registering the actual start time of recruitment.
empty
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Protocol summary
Study aim
Evaluating the effect of oral Pantoprazole in stomach pH
Design
open-label phase 3 controlled paralleled clinical trial of 80 patients by simple randomization
Settings and conduct
ٍEighty patients aged 0-15 years will be recruited in the study regarding inclusion and exclusion criteria. The patients will be admitted to Mofid children hospital and will be randomly divided into two intervention and control groups; in the intervention group, oral pantoprazole dissolved in Bicarbonate 8.4 percent solution by 1 milligram per kilogram dose every 12 hours. In the control group, patients receive standard treatment of parenteral Pantoprazole by 1 milligram per kilogram dose every 12 hours. After 48 hours gastric pH would be measured by nasogastric tube sample. Patient will follow-up for 2 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pediatric intensive care unit admission, Mechanical ventilation, Naso-gastric tube placement. Exclusion criteria: Pantoprazole sensitivity, Active gastrointestinal bleeding, History of gastrointestinal ulcer.
Intervention groups
ٍEighty patients aged 0-15 years will be recruited in the study regarding inclusion and exclusion criteria. The patients will be admitted to Mofid children hospital and will be randomly divided into two intervention and control groups; in the intervention group, oral pantoprazole dissolved in Bicarbonate 8.4 percent solution by 1 milligram per kilogram dose every 12 hours. In the control group, patients receive standard treatment of parenteral Pantoprazole by 1 milligram per kilogram dose every 12 hours.
Main outcome variables
Stress ulcer occurrence;
Diarrhea occurrence;
Pneumonia occurrence;
Morbidity and mortality
General information
Reason for update
There was a mistake in registering the actual start time of recruitment.
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009475N7
Registration date:2020-01-21, 1398/11/01
Registration timing:retrospective
Last update:2020-04-26, 1399/02/07
Update count:1
Registration date
2020-01-21, 1398/11/01
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-11-22, 1398/09/01
Trial completion date
2019-11-22, 1398/09/01
Scientific title
comparison of the effectiveness of parenteral Pantoprazole with oral Pantoprazole plus bicarbonate on gastric pH in children
Public title
comparison of the parenteral and oral Pantoprazole in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pediatric intensive care unit admission
Mechanical ventilation
Naso-gastric tube placement
Exclusion criteria:
Pantoprazole sensitivity
Active gastrointestinal bleeding
History of gastrointestinal ulcer
Age
From 1 month old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization executed by random numbers table generated by excel program. Patients individually will be allocated to intervention and control groups by odd and even succession of numbers in the table. There is no allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی
Street address
Sharyati Ave.,Mofid hospital
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2019-06-10, 1398/03/20
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.080
Health conditions studied
1
Description of health condition studied
Stress ulceration prevention
ICD-10 code
K92.81
ICD-10 code description
Gastrointestinal mucositis (ulcerative)
Primary outcomes
1
Description
Patient's stomach pH
Timepoint
48 hours after starting treatment
Method of measurement
By litmus paper
Secondary outcomes
1
Description
Diarrhea occurrence
Timepoint
During 14 day after treatment
Method of measurement
Nurse report
2
Description
Pneumonia occurrence
Timepoint
During 14 day after treatment
Method of measurement
Based on diagnosis criteria
3
Description
Morbidity and mortality
Timepoint
Until patient discharge
Method of measurement
By report
4
Description
stress ulcer occurrence
Timepoint
During 14 day after treatment
Method of measurement
gastric lavage
Intervention groups
1
Description
Intervention group: In this group patients receive oral pantoprazole dissolved in Bicarbonate 8.4 percent solution by 1 milligram per kilogram dose every 12 hours.
Category
Treatment - Drugs
2
Description
Control group: In this group patients receive standard treatment of parenteral Pantoprazole by 1 milligram per kilogram dose every 12 hours.