Comparison the therapeutic effects of two drugs of Bosentan and Sildenafil on pulmonary artery pressure in newborns with PPHN
Design
This study is a clinical trial. Randomized numerical formulas using Excel has been used for randomization.
Settings and conduct
This study is a clinical trial. All new born with respiratory distress, decreased Sat o2 and cyanosis is admitted to the NICU of Akbarabadi and Ali Asghar hospitals, who had inclusion criteria, entered the study after parents' consent.
Participants/Inclusion and exclusion criteria
All newborns with respiratory distress, decreased of Sat o2 and cyanosis admitted to the NICU of Akbarabadi and Ali Asghar hospital and if the echocardiography findings are based on pulmonary artery pressure higher than or equal to 25 mmHg and the severity of tricuspid valve regurgitation higher than or equal to 30 mmHg with or without right to left shunt, after obtaining the consent of the parents entered the study. Other cyanotic heart disease rejected, there is no other cyanotic justifying disease. PPHN is not due to pneumonia or meconium aspiration.
Intervention groups
Newborns with PPHN treated with Bosentan tablets1mg/kg/dose every 12 hours through PG.
Newborns with PPHN treated with sildenafil tablet 0.4mg/kg/dose every 12 hours through PG.
Main outcome variables
Pulmonary artery pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190127042504N1
Registration date:2019-02-22, 1397/12/03
Registration timing:retrospective
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
saba farhangdoust
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 7959
Email address
farhangdoust.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-16, 1396/03/26
Expected recruitment end date
2018-06-16, 1397/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Bosentan and Sildenafil in the treatment of persistent pulmonary hypertension of the newborn
Public title
Comparison of Bosentan and Sildenafil in the treatment of persistent pulmonary hypertension of the newborn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All new borns with respiratory distress, decreased of Sat o2 and cyanossies admitted to the NICU of Akbarabadi and Ali Asghar hospital
If the echocardiography findings are based on pulmonary artery pressure higher than or equal to 25 mmHg
The severity of tricuspid valve regurgitation higher than or equal to 30 mmHg with or without right to left shunt
Obtaining the consent of the parents
Exclusion criteria:
Other cyanotic heart disease
No other cyanotic justifying disease
PPHN is not due to pneumonia or meconium aspiration
Age
From 1 day old to 30 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization of the formulation used in Excel software, the coupled numbers obtained in this table will be allocated to the drug A, namely, Bosentan and the individual numbers for the drug B, Sildenafil.
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomization is double blind. On the other hand, the neonates, according to their age and their parents, and on the other hand, the pediatric cardiologist who perform echocardiography before and after the treatment, and the analyzor has no information about the type of drug.The information for the two groups is provided as code A or B to the analyzer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-06-13, 1396/03/23
Ethics committee reference number
IR.IUMS.FMD.REC1396.9511165012
Health conditions studied
1
Description of health condition studied
Persistent pulmonary hypertension of newborn
ICD-10 code
I26-28
ICD-10 code description
Persistent pulmonary hypertension
Primary outcomes
1
Description
Pulmonary artery pressure
Timepoint
At the start of study and then 1week after
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Comparison of the duration of treatment in the two groups
Timepoint
daily visit
Method of measurement
Physical examination
2
Description
Comparison of the duration of O2 as needed in two groups
Timepoint
Daily visit
Method of measurement
Pulseoximetery
3
Description
Comparrison of side effect in 2 groups
Timepoint
Daily visit,weekly labratory test
Method of measurement
Blood pressure,labratory
Intervention groups
1
Description
Intervention group 1: Newborns with PPHN treated with Bosentan tablet 1mg/kg/dose every 12 hours through PG until 1 mounths
Category
Treatment - Drugs
2
Description
Intervention group2 : Newborns with PPHN treated with sildenafil tablet 0.4 mg/kg/dose every 12 hours through PG until 1 mounths
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi hospital and Ali asghar Children's Hospital
Full name of responsible person
Saba Farhangdoust
Street address
No, 193, Madares Highway, Dastgerdi St, Ali Asghar children's hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2261 7957
Email
farhangdoust1980@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saba Farhangdoust
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No,193, Ali Asghar Children Hospital, Dastgerdi St., Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2261 7959
Email
farhangdoust1980@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saba Farhangdoust
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No,193, Ali Asghar Children Hospital, Dastgerdi St., Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2261 7959
Email
farhangdoust1980@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saba Farhangdoust
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No,193, Ali Asghar Children Hospital, Dastgerdi St., Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2261 7959
Email
farhangdoust1980@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available