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گروه مداخله 1: سورفکتانت کوروسورف (شرکت Chiesi، ایتالیا) بادوز 100 میلی گرم به ازای هر کیلوگرم ازطریق لوله تراشه.
گروه مداخله 1: سورفکتانت کوروسورف (شرکت Chiesi، ایتالیا) بادوز 200 میلی گرم به ازای هر کیلوگرم ازطریق لوله تراشه.
گروه مداخله 1: سورفکتانت کوروسورف (شرکت Chiesi، ایتالیا) بادوز 100200 میلی گرم به ازای هر کیلوگرم ازطریق لوله تراشه.
Protocol summary
Study aim
The aim of this study is comparing the effects of Curosurf and BLES surfactants in the treatment of neonatal respiratory distress syndrome (RDS).
Design
Study design: Randomized double-blind clinical trial. Patients will be assigned into two groups to recieve either Curosurf surfactant (n=80) or BLES surfactant (n=80).
Settings and conduct
Among patients with RDS admitted to NICU of Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 160 patients will be selected according to inclusion and exclusion criteria. The medical team, parents, and outcome assessor are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Neonates with RDS, gestational age of 32 weeks or less. Exclusion criteria: Congenital anomalies, Apgar score less than 4 at 5 minutes, meconium aspiration syndrome. prolonged premature rupture of membrane, parents declined to participate.
Outcomes: the number of surfactant injection (primary outcome) and length of oxygen dependency, duration of hospital stay, and complications of prematurity (secondary outcomes) will be evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N54
Registration date:2019-03-30, 1398/01/10
Registration timing:retrospective
Last update:2019-04-06, 1398/01/17
Update count:2
Registration date
2019-03-30, 1398/01/10
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-01-07, 1397/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of two natural surfactants, Curosurf® and BLES®, in treatment of respiratory distress syndrome in preterm neonates
Public title
Comparing Curosurf® and BLES® in treatment of respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Neonates with respiratory distress syndrome (RDS)
gestational age of 32 weeks or less.
Exclusion criteria:
Exclusion criteria: congenital anomalies.
Apgar score less than 4 at 5 minutes.
neonates with meconium aspiration syndrome.
prolonged premature rupture of membrane.
parents declined to participate.
Age
From 1 day old to 1 day old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Neonates will be randomly assigned into two groups. A randomization list will be generated from 1 to 160 by SPSS software (version 16) and neonates were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation concealment will be done by having procedure indicator cards inside a set of opaque sealed envelopes. The medical team, parents, and outcome assessor are unaware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences