Introduction:Use of natural surfactant rather than synthetic surfactants are preferred in the treatment of neonatal respiratory distress syndrome, although several different types of natural surfactant in Iran (Alveofact, curosurf and Survanta) is available but the preferred type and the magnitude of effect of Surfactants is largely unknown . The purpose of this randomized clinical trial is comparing the effects of surfactants on gas exchange and clinical outcomes in infants with respiratory distress syndrome. for evaluating this aim, 165 Infants born in Talegani Hospital in Tabriz at a gestational age of 36 weeks or less with respiratory distress syndrome in a prospective, randomized clinical trial were studied. inclusion criteria was all under 38 weeks GA neonate without anomaly and Exclusion criteria were congenital anomalies, birth asphyxia (Apgar score less than 4 at 5 minutes) and gestational age over 36 weeks. Infants were randomly assigned by computer randomization to three groups: the first group received Alveofact, Group II received Curosurf and Group III proctant alfa (Survanta ) with INSUR method .clinical standards (the oxygen demand, the incidence of ventilator dependency, BPD, IVH and .. .) and blood gases were analyzed and recorded in three group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411028680N5
Registration date:2014-11-21, 1393/08/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-21, 1393/08/30
Registrant information
Name
Mirhadi Mussavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 2094
Email address
mousavi-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2014-10-19, 1393/07/27
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Efficacy of three Natural Surfactants, Curosurf ,Survanta and Alveofact, in Treatment of Respiratory Distress Syndrome in Infants
Public title
Evaluating the Efficacy of Surfactants, Curosurf ,Survanta and Alveofact, in Respiratory Distress Syndrome in Infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Infants born at a gestational age of 36 weeks or less
Exclusion criteria: congenital anomalies, birth asphyxia (Apgar score less than 4 at 5 minutes) and gestational age over 36 weeks
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commite ofTabriz University Of Medical Sciences
Street address
Golgasht Av
City
Tabriz
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
8745
Health conditions studied
1
Description of health condition studied
Neonatal respiratory distress
ICD-10 code
P22
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Base exhess change
Timepoint
After intervention
Method of measurement
Blood gas analysis
2
Description
Pco2 Change
Timepoint
After intervention
Method of measurement
Blood gas analysis
3
Description
duration of oxygen dependency
Timepoint
Up to 7 daye after intervention
Method of measurement
Oxygen Saturation analysis with pulsoxymetery
4
Description
CPAP Failure
Timepoint
After intrvention
Method of measurement
Blood gas analysis
Secondary outcomes
1
Description
Intraventricular hemorrhage
Timepoint
Up to 7 days after intervention
Method of measurement
Brain sonography
2
Description
Patent ductus arteriosus
Timepoint
Up to 7 days after intervention
Method of measurement
Echocardiography
3
Description
Broncho pulmonary dysplasia
Timepoint
up to 28 daye old
Method of measurement
Chest X-ray
4
Description
Mortality
Timepoint
Up to 28 days after intervention
Method of measurement
clinical finding
Intervention groups
1
Description
1 st dose of Survanta 100 mg/kg via endotracheal tube
Category
Treatment - Drugs
2
Description
1 st dose of Curosurf 200 mg/kg via endotracheal tube
Category
Treatment - Drugs
3
Description
1 st dose of Alveofact 100 mg/kg via endotracheal tube
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mussavi,Mirhadi
Street address
Artesh Av
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammadreza
Street address
Golgasht av
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mussavi,Mirhadi
Position
Neonatologist /Assistant professor
Other areas of specialty/work
Street address
Alzahra Hospital
City
Tabriz
Postal code
Phone
+98 413272094
Fax
Email
drmussavihadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mussavi,Mirhadi
Position
Neonatologist
Other areas of specialty/work
Street address
Alzahra Hospital
City
Tabriz
Postal code
Phone
+98 41 3327 2094
Fax
Email
drmussavihadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mussavi,Mirhadi
Position
Neonatologist
Other areas of specialty/work
Street address
Alzahra Hospital
City
Tabriz
Postal code
Phone
+98 41 3327 2094
Fax
Email
drmussavihadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)