Evaluation of heparin nebulize efficacy in the treatment in pediatric patients with Acute Respiratory Distress Syndrome
Design
The clinical trial with a control, parallel group, double-blined, randomize, in third clinical phase on 66 patients . Six Block Random Permutation and Microsioft Excel 2010 software will be used randomization.
Settings and conduct
Since the participants in this research are children under the age of 18, they will not know about how they will be placed in treatment groups, due to the age limit.
Also, due to the impossibility of making a placebo, a person outside of the research group will be responsible for injecting the drug, and this person has no interference in collecting and analyzing data.
In addition, the people who are responsible for collecting and analyzing information will not have any information about how patients are placed in these groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 1 month to 18 years
Patients with respiratory distress syndrome
Exclusion criteria:
History of any bleeding disorders
Uncontrolled active bleeding
Intervention groups
In two groups, patients receive their main medicine. In placebo group,distilled water nebulizer is used with dose of 0.5 milliliter per kilogram of body weight every 12 hours. In intervention group, heparin nebulizer is used with 100 unit per kilogram of body weight every 12 hours for seven days. All the patients respiratory information like Fio2/Pao2 and the respiratory indices will be recorded at the certain time ten minutes before the ventilator is changed and patients position.
Main outcome variables
Respiratory Syndrome Severity؛ ventilation days need
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230724058907N1
Registration date:2023-12-11, 1402/09/20
Registration timing:prospective
Last update:2023-12-11, 1402/09/20
Update count:0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Fatemeh Minagar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4244 2249
Email address
minagar.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of nebulized heparin efficacy in pediatric patients with acute respiratory distress syndrome
Public title
Evaluation of nebulized heparin efficacy in acute respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children older than one month to 18 years old
The underlying disease of acute respiratory distress syndrome
Patients under mechanical ventilation for more than 48 hours with Pao2/Fio2<300
Patients who are expected to undergo invasive ventilation in the next 24 hours
In CXR, bilateral pulmonary infiltration can be seen (5cmH2O PEEP>)
Exclusion criteria:
History of allergy to heparin
Bleeding history in the last 3 months
History of any bleeding and coagulation disorders
History of cerebral hemorrhage in the last year
Uncontrolled active bleeding
Simultaneous use of antiplatelet, anticoagulant and thrombolytic drugs
Unwillingness to participate in the study
Age
From 1 month old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this part "www.sealedenvelope.com" will be used to create random blocks to assign patients into groups and as a result a sequence of four blocks will be made. Considering that we have two groups in this study, our blocks of four can be as follows:
AABB, ABAB, BABA, BBAA, BAAB, ABBA
where A and B represent our groups. Then these six blocks will be numbered, and samples will be taken from these six blocks by replacement method. These blocks will then be put together to form our randomization sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be done in a double-blind method.Neither the patient nor the doctor know how to be placed in the groups. To consider the age of the patients and the usual condition of consciousness in the ICU, it can be claimed none of them are aware of the drugs they are receiving. Because of the impossibility of making a placebo, this study will be done in a double blind manner in two intervention ( heparin nebulize) and placebo (Distilled water nebulize) groups. It will be done completely randomly by a person outside the research team who has no interference in the collection and analysis of data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ground floor, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz , Iran.
Oxygen saturation with palse oximetry to fraction of inspired oxygen ratio
Timepoint
Time to enter the study or 0, 3, 5 and 7 days
Method of measurement
Pulse oximetry and mechanical ventilator
2
Description
Arterial oxygen pressure by arterial blood gas to fraction of inspired oxygen ratio
Timepoint
Time to enter the study or 0, 3, 5 and 7 days
Method of measurement
Blood sample and mechanical ventilator
3
Description
Oxigen saturation index ( fraction of inspired oxygen *mean airway pressure*100 ) to oxygen saturation by palse oximetry ratio
Timepoint
Time to enter the study or 0, 3, 5 and 7 days
Method of measurement
Pulse oximetry and mechanical ventilator
4
Description
Oxygenation index (fraction of inspired oxygen *mean airway pressure*100) to oxygen saturation by arterial blood gas ratio
Timepoint
Time to enter the study or 0, 3, 5 and 7 days
Method of measurement
Blood sample and mechanical ventilator
5
Description
Number of days required mechanical ventilation
Timepoint
Time to enter the study to discharge
Method of measurement
Patient file
6
Description
Length of stay in Intensive Care Unit
Timepoint
Time to enter the study to discharge
Method of measurement
Patient file
7
Description
Adverse effect
Timepoint
Full time of study
Method of measurement
Patient file and tests
Intervention groups
1
Description
Intervention group with nebulized heparin 5000 unit per 1 milliliter Sina darou (preservative free) with dose100 Unit per kilogram of body weight every 12hours for 7 days
Category
Treatment - Drugs
2
Description
Control or placebo group with nebulized distilled water Caspian company 0.5 milliliter per kilogram of body weight every 12hours for 7 days