Comparison of efficacy and safety of two natural surfactants, Curosurf and Survanta in treatment of respiratory distress syndrome: A randomized clinical trial
This study aimed to compare the effectiveness and safety of Curosurf and Survanta in treatment of respiratory distress syndrome (RDS). One hundred and twelve neonates were born with RDS diagnosis in Najmieh and Baqiyatallah hospitals in 2014 were randomly selected. Other inclusion criteria were weight of 750 to 1750 gr; gestational age less than 35 weeks; O2 saturation 85% to 96%; signed informed consent by parents, and age ≤ 6 hours at the time of randomization. RDS diagnosis was based on clinical picture of infant with the onset of progressive respiratory failure shortly after birth, in conjunction with a characteristic chest radiograph. Neonates with congenital heart diseases and other life threatening anomalies, respiratory failure due to other causes except RDS, 5 minute Apgar score ≤ 3, and proven fetal lung maturity profile from amniocentesis were excluded from study. Neonates were randomly assigned into two groups. Randomization was stratified by birth weight with two birth weight strata (750 to 1250 gr and 1250 to 1750 gr). After intubation the groups one and two infants were received 100 mg/kg Curosurf or Survanta as soon as possible after randomization. The efficacy and RDS complications were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071017413N12
Registration date:2015-09-01, 1394/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-01, 1394/06/10
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of two natural surfactants, Curosurf and Survanta in treatment of respiratory distress syndrome: A randomized clinical trial
Public title
Comparison of efficacy and safety of two natural surfactants, Curosurf and Survanta in treatment of neonatal respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Neonates were born with RDS diagnosis in Najmieh and Baqiyatallah hospitals; weight of 750 to 1750 gr; gestational age less than 35 weeks; O2 saturation 85% to 96%; signed informed consent by parents; and age ≤ 6 hours at the time of randomization. Exclusion criteria: Congenital heart diseases and other life threatening congenital anomalies; respiratory failure due to other causes, 5 minute Apgar score ≤ 3; proven fetal lung maturity profile from amniocentesis; prior treatment with exogenous surfactant; prolonged (≥ 3 weeks) rupture of membranes; untreated hypotension or hypoglycemia; use of high-frequency ventilation prior to first dose of surfactant; and severe grades of intra-ventricular hemorrhage (grades III or IV) prior to surfactant.
Age
To 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Approval date
2015-05-10, 1394/02/20
Ethics committee reference number
IR.BMSU.REC.1394.107
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Needing second surfactant dose
Timepoint
12 to 24 hours after the first surfactant dose
Method of measurement
Yes / No
2
Description
Hospital stay
Timepoint
At the time of discharge
Method of measurement
Days
3
Description
Mortality
Timepoint
During the hospital stay
Method of measurement
Dead / alive
4
Description
Needing nasal continuous positive airway pressure
Timepoint
During the hospital stay
Method of measurement
Yes / No
5
Description
Needing endotracheal tube
Timepoint
During the hospital stay
Method of measurement
Yes / No
6
Description
RDS-related complications
Timepoint
During the hospital stay
Method of measurement
Yes / No
Secondary outcomes
empty
Intervention groups
1
Description
After intubation the group one infants were received 100 mg/kg Curosurf as soon as possible after randomization.
Category
Treatment - Drugs
2
Description
After intubation the group two infants were received 100 mg/kg Survanta as soon as possible after randomization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Sobhan Amin
Street address
Baqiyatallah Hospital, Sheikh Bahaei St. Mollasadra St. Vanak Sq. Tehran, I.R.Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Najmieh Hospital
Full name of responsible person
Bita Najafian
Street address
Baqiyatallah Hospital, Sheikh Bahaei St. Mollasadra St. Vanak Sq. Tehran, I.R.Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences, Deputy of Research
Full name of responsible person
Gholam Hossein Alishiri
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
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
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
Full name of responsible person
Hamidreza Karimi-Sari
Position
General practitioner / Researcher
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
1761673831
Phone
+98 21 8126 4354
Fax
Email
dr.karimih@yahoo.com
Web page address
http://bmsusrc.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pediatrics, Baqiyatallah University of Medical Sciences, Tehran, Iran
Full name of responsible person
Bita Najafian
Position
Assistant Professor
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
Email
dr.najafian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
Full name of responsible person
Hamidreza Karimi-Sari
Position
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
Email
dr.karimih@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)