Evaluation of hospitalization period and duration of supplemental oxygen requirement and possible complications (pneumonia, intracerebral hemorrhage, intrapulmonary hemorrhage, necrotizing enterocolitis) and duration of oral feeding and re-need of surfactant injection after initial injection in two groups receiving surfactant With two different doses.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients
Settings and conduct
Neonatal Intensive Care Unit (NICU) of Valiasr Hospital in Birjand, in the field of treatment and the mentioned infants are randomly divided into two groups and each group is prescribed a different dose of endotracheal surfactant.
The patient group and the data evaluator and data analyst group do not know the dose given in the two groups.
Participants/Inclusion and exclusion criteria
All infants with acute respiratory distress syndrome(RDS) need medical treatment / unless they have undergone cardiac resuscitation at birth
Intervention groups
Neonates admitted to the neonatal intensive care unit(NICU) with a diagnosis of acute respiratory distress syndrome(RDS) are randomly divided into two groups, and each group receives a prescribed dose of surfactant (100 mg/kg or 200 mg/kg) for that group.
Main outcome variables
Duration of hospitalization, complications of treatment, need for mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210102049921N1
Registration date:2021-05-31, 1400/03/10
Registration timing:prospective
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Reza Poorhoseiny
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3162 2001
Email address
reza.poorhoseiny52@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-06, 1400/03/16
Expected recruitment end date
2021-09-07, 1400/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect and outcome of Surfactant (CUROSURF) with doses 100 & 200 mg/kg in neonates with respiratory distress syndrome
Public title
Effect different doses of Surfactant (CUROSURF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with respiratory distress syndrome
Requires treatment with Surfactant
Exclusion criteria:
Cardiopulmonary resuscitation during labour
Age
To 2 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Lack of information of the given drug dose in patients and data analyst and outcome assessor
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2020-12-21, 1399/10/01
Ethics committee reference number
IR.BUMS.REC.1399.421
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn (RDS)
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Calendar
2
Description
Complications of treatment
Timepoint
Duration of hospitalization
Method of measurement
Chest-X-ray and clinical observation
3
Description
Requires a variety of auxiliary ventilation
Timepoint
every hour
Method of measurement
Digital clock
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intratracheal injection of surfactant under the brand name Curosurf at a dose of 100 mg/kg made by Chiesi Farmaceutici factory(Italy)
Category
Treatment - Drugs
2
Description
Intervention group: Intratracheal injection of surfactant under the brand name Curosurf at a dose of 200 mg/kg made by Chiesi Farmaceutici factory(Italy)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-asr
Full name of responsible person
Mahmoudirad Alireza
Street address
Razi AVE., Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
valiasr@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Kazemi Tooba
Street address
Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Reza Poorhoseiny
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Valiasr Hospital, Gafari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Fax
Email
Reza.poorhoseiny52@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Reza Poorhoseiny
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Valiasr Hospital, Gafari Ave.
City
Birjand
Province
South Khorasan
Postal code
971796415
Phone
+98 56 3162 2001
Fax
Email
Reza.poorhoseiny52@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Reza Poorhoseiny
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Valiasr Hospital, Gafari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Fax
Email
Reza.poorhoseiny52@bums.ac.ir
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