Evaluation of the effect of oral sildenafil addition to injection routine (milirinone) in infants with pulmonary hypertension
Design
A non- randomized, double-blind, placebo-controlled clinical trial. This study will be performed on 80 patients with pulmonary hypertension .These people are non-random are divided into two groups of 40 people using minimization method and minim software،Control group and group receiving oral sildenafil
Settings and conduct
This study will be carried out in the neonatal ward of Afzalipour Hospital. In the first phase, 80 patients will be divided into control and intervention groups Using non-minimizing method with minim software.In the intervention group, oral sildenafil was given in combination with injectable milrinone and in the control group only injectable milrinone was administered72 hours later, both groups will have echocardiography
Participants/Inclusion and exclusion criteria
Inclusion criteria included: neonates admitted to neonatal ward of Afzalipour Hospital, gestational age of 34 weeks or more, confirmation of high blood pressure diagnosis by echocardiography, and parental consent, and exclusion criteria included congenital heart disease and major abnormalities at birth
Intervention groups
In the intervention group sildenafil (3 mg per kg daily) with milirinone and in the control group only injectable milirinone
The echocardiography is performed and re-echocardiography is performed 72 hours later for both groups
Main outcome variables
Changes in the treatment process and improvement of pulmonary hypertension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190731044393N1
Registration date:2019-10-04, 1398/07/12
Registration timing:registered_while_recruiting
Last update:2019-10-04, 1398/07/12
Update count:0
Registration date
2019-10-04, 1398/07/12
Registrant information
Name
Maryam Ebrahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3325 7000
Email address
maryamebrahimpour1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Sildenafil Nutrition on the Treatment of Injection Routine (Milirinone) in Infants with Pulmonary Hypertension
Public title
Evaluation of the Effect of Sildenafil Nutrition on the Treatment of Injection Routine (Milirinone) in Infants with Pulmonary Hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants hospitalized in neonatal wards of Afzalipour Hospital
Parental Satisfaction
Gestational age greater than or equal to 34 weeks
Confirmation of diagnosis of high blood pressure by echocardiography
Exclusion criteria:
Congenital heart disease
The birth of a major anomaly
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, drug interventions are considered and infants' parents will be blinded to the type of neonatal treatment And to evaluate the neonatal pulmonary pressure, an out-of-group evaluator is used to evaluate the type of blind treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Ibn Sina Street،Jihad Boulevard
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2019-05-29, 1398/03/08
Ethics committee reference number
IR.KMU.AH.REC.1398.038
Health conditions studied
1
Description of health condition studied
Pulmonary hypertension
ICD-10 code
I27.0
ICD-10 code description
Primary pulmonary hypertension
Primary outcomes
1
Description
Evidence of pulmonary hypertension
Timepoint
The first day and 72 hours later
Method of measurement
Eco cardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group sildenafil (3 mg / kg / day) is given with milrinone
Category
Treatment - Drugs
2
Description
Control group: In control group only injectable milrinone is prescribed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Kerman Hospital
Full name of responsible person
Maryam Ebrahimpour
Street address
Afzalipour Hospital, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
maryamebrahimpour1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Payakhti
Street address
Ibn Sina Street،Jihad Boulevard,
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
maryamebrahimpour1373@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
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
Kerman University of Medical Sciences
Full name of responsible person
Maryam Ebrahimpour
Position
Infant Fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Afzalipour Hospital, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
maryamebrahimpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Ebrahimpour
Position
Infant Fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Afzalipour Hospital, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
maryamebrahimpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Ebrahimpour
Position
Infant Fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Afzalipour Hospital,Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
maryamebrahimpour@gmail.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