evaluation of the therapeutic effect of sildenafil in neonates with chronic lung disease
Comparison of oxygen demand in sildenafil patients and controls
Comparison of hospital stay, pulmonary pressure and Systemic Blood Pressure Changes in sildenafil patients and controls
Design
randomized clinical trial with parallel Controlled group, single-blind
Settings and conduct
Approximately 40 patients (those referred to Al-Zahra Hospital with a diagnosis of chronic lung disease in one year) will enter the study in accordance with the entry and exit criteria. Patients will be divided into control and study groups using Randomiser.org. All patients will receive routine and necessary measures, and after obtaining written consent from the parents to participate in the study, and confirmation of increased pulmonary pressure by echocardiography performed by a pediatric cardiologist, sildenafil tablets in the intervention group and placebo It will start as a form of control in the control group for patients, and parents will not know about the drug or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Chronic lung disease based on the need for oxygen at 36 weeks of gestation
Neonatal hemodynamic stability
Lack of gastrointestinal disorders
Written consent of the patient's parents to participate in the study
Output Criteria:
Need oxygen at 36 weeks of intrauterine age for known causes other than -Nutritional intolerance
Intervention groups
Intervention group: Sildenafil 50 mg tablets of Obaidi company with a dose of 2 mg per kilogram of body weight will be given to infants orally every 8 hours.
Control group: The placebo will start as a single form and one color with the same characteristics of sildenafil tablets for patients.
Main outcome variables
Arterial oxygen saturation control
Reduction of hospital stay
Systemic blood pressure control
Pulmonary blood pressure control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160102025811N4
Registration date:2020-04-17, 1399/01/29
Registration timing:retrospective
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Mirhadi Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 2094
Email address
drmussavihadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of Sildenafil on Improving Chronic Lung Disease of neonates
Public title
Sildenafil on Improving Chronic Lung Disease of neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic pulmonary disease based on oxygen demand in 36 weeks of intrauterine age
Infant hemodynamic stability
Absence of gastrointestinal disorders
Written consent of the patient's parents to participate in the study
Exclusion criteria:
Parents 'dissatisfaction with patients' participation in the study
The need for oxygen during the 36 weeks of intrauterine age is known due to chronic lung disease
Hemodynamic instability
Nutritional intolerance
Age
To 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Referred to Alzahra Hospital with Chronic Pulmonary Disease
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random allocation software: Random allocation software. So that all patients who were hospitalized in Al-Zahra Medical Center in Tabriz in 1398 and 1399 with the diagnosis of chronic lung disease and had entry criteria and no exit criteria, will enter the study. Using the software, they will be divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients will undergo routine measures such as respiratory support and oxygen therapy, and after obtaining written consent from parents to participate in the study, sildenafil 50 mg overdose tablets at a dose of 2 mg per Kg of body weight will be started every 8 hours in the intervention and placebo tablets in the same color form as patients with the same characteristics in the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee of Tabriz University of Medical Sciences
Street address
GOLGASHT Ave, Faculty of Medicine
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.TBZMED.REC.1398.488
Health conditions studied
1
Description of health condition studied
Chronic lung disease of newborns
ICD-10 code
P00.3
ICD-10 code description
Newborn (suspected to be) affected by other maternal circulatory and respiratory diseases
Primary outcomes
1
Description
Fio2
Timepoint
daily
Method of measurement
Oxymetric pulse and heart monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sildenafil 50 mg tablets from Obidi Company with a dose of 2 mg per kg body weight will be fed to infants every 8 hours.
Category
Treatment - Drugs
2
Description
Control group: The placebo will be given to babies in the same shape and color as Sildenafil.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Mir Hadi Musavi
Street address
Sheshgalan Street, Children's Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۷۵۱۶۳۷
Phone
+98 41 3337 2084
Email
mirhadimousavi33@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hasan Soleimanpour
Street address
Golgasht Street - Faculty of Medicine
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۷۵۱۶۳۷
Phone
+98 41 3337 2084
Email
mirhadimousavi33@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
MirHadi Mousavi
Position
Assistant Prof.
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Seshgelan St, Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
mirhadimousavi33@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mirhadi Mousavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۷۵۱۶۳۷
Phone
+98 41 3327 2094
Fax
+98 41 3327 2095
Email
drmussavihadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mousavi Mirhadi
Position
Neonatologist
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Pediatric Hospital,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۷۵۱۶۳۷
Phone
+98 41133272094
Fax
Email
drmussavihadi@yahoo.com
Web page address
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