Protocol summary
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Study aim
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Evaluating the effect of oral Pantoprazole in stomach pH
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Design
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open-label phase 3 controlled paralleled clinical trial of 80 patients by simple randomization
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Settings and conduct
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ٍ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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Pediatric intensive care unit admission, Mechanical ventilation, Naso-gastric tube placement. Exclusion criteria: Pantoprazole sensitivity, Active gastrointestinal bleeding, History of gastrointestinal ulcer.
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Intervention groups
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ٍ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.
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Main outcome variables
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Stress ulcer occurrence;
Diarrhea occurrence;
Pneumonia occurrence;
Morbidity and mortality
General information
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Reason for update
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There was a mistake in registering the actual start time of recruitment.
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Acronym
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IRCT registration information
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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
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Registration date
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2020-01-21, 1398/11/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-23, 1397/07/01
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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2019-06-22, 1398/04/01
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Actual recruitment end date
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2019-11-22, 1398/09/01
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Trial completion date
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2019-11-22, 1398/09/01
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Scientific title
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comparison of the effectiveness of parenteral Pantoprazole with oral Pantoprazole plus bicarbonate on gastric pH in children
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Public title
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comparison of the parenteral and oral Pantoprazole in children
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pediatric intensive care unit admission
Mechanical ventilation
Naso-gastric tube placement
Exclusion criteria:
Pantoprazole sensitivity
Active gastrointestinal bleeding
History of gastrointestinal ulcer
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Age
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From 1 month old to 15 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
Actual sample size reached:
81
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-10, 1398/03/20
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1398.080
Health conditions studied
1
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Description of health condition studied
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Stress ulceration prevention
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ICD-10 code
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K92.81
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ICD-10 code description
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Gastrointestinal mucositis (ulcerative)
Primary outcomes
1
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Description
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Patient's stomach pH
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Timepoint
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48 hours after starting treatment
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Method of measurement
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By litmus paper
Secondary outcomes
1
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Description
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Diarrhea occurrence
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Timepoint
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During 14 day after treatment
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Method of measurement
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Nurse report
2
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Description
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Pneumonia occurrence
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Timepoint
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During 14 day after treatment
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Method of measurement
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Based on diagnosis criteria
3
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Description
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Morbidity and mortality
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Timepoint
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Until patient discharge
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Method of measurement
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By report
4
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Description
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stress ulcer occurrence
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Timepoint
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During 14 day after treatment
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Method of measurement
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gastric lavage
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: In this group patients receive standard treatment of parenteral Pantoprazole by 1 milligram per kilogram dose every 12 hours.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The main outcome will be available.
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When the data will become available and for how long
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Six months after publishing data.
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To whom data/document is available
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The data will be available per request for people working in academic institutions.
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Under which criteria data/document could be used
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The data will available for using in systematic review and meta-analysis.
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From where data/document is obtainable
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The data will be available by contacting email; mirrahimi@sbmu.ac.ir.
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What processes are involved for a request to access data/document
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The data will available for using in systematic review and meta-analysis.
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Comments
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