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General information
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160
160
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2018-04-21, 1397/02/01
2018-04-21 00:00:00
empty
2021-11-07, 1400/08/16
2021-11-07 00:00:00
empty
2022-02-05, 1400/11/16
2022-02-05 00:00:00
empty
Updating process was done before publishing the paper to correct the registration information.
Updating process was done before publishing the paper to correct the registration information.
empty
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پروسه بروز رسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام شد.
شرایط ورود به مطالعه : نوزادان مبتلا به سندرم زجر تنفسی
سن حاملگی 32 هفته یا کمتر.
شرایط ورود به مطالعه: نوزادان مبتلا به سندرم زجر تنفسی
سن حاملگی 32 هفته یا کمتر.
شرایط ورود به مطالعه: نوزادان مبتلا به سندرم زجر تنفسی سن حاملگی 32 هفته یا کمتر.
شرایط خروج از مطالعه : ناهنجاری های مادرزادی.
نمره آپگار دقیقه 5 کمتر از 4 .
نوزادان مبتلا به سندرم آسپیراسون مکونیوم.
پارگی کیسه آب زودرس طول کشیده.
عدم رضایت آگاهانه والدین.
شرایط خروج از مطالعه: ناهنجاری های مادرزادی.
نمره آپگار دقیقه 5 کمتر از 4.
نوزادان مبتلا به سندرم آسپیراسون مکونیوم.
پارگی کیسه آب زودرس طول کشیده.
عدم رضایت آگاهانه والدین.
شرایط خروج از مطالعه: ناهنجاری های مادرزادی. نمره آپگار دقیقه 5 کمتر از 4. نوزادان مبتلا به سندرم آسپیراسون مکونیوم. پارگی کیسه آب زودرس طول کشیده. عدم رضایت آگاهانه والدین.
Primary outcomes
#1
after the intervention
After the intervention
afterAfter the intervention
checklist
Checklist
checklistChecklist
Secondary outcomes
#1
length of oxygen dependency
Length of oxygen dependency
lengthLength of oxygen dependency
after the intervention
After the intervention
afterAfter the intervention
checklist
Checklist
checklistChecklist
#2
duration of hospital stay
Duration of hospital stay.
durationDuration of hospital stay.
after the intervention
After the intervention
afterAfter the intervention
checklist
Checklist
checklistChecklist
#3
complications of prematurity
Complications of prematurity
complicationsComplications of prematurity
after the intervention
After the intervention
afterAfter the intervention
checklist
Checklist
checklistChecklist
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
Updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N54
Registration date:2019-03-30, 1398/01/10
Registration timing:registered_while_recruiting
Last update:2023-07-19, 1402/04/28
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
2018-04-21, 1397/02/01
Actual recruitment end date
2021-11-07, 1400/08/16
Trial completion date
2022-02-05, 1400/11/16
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
Actual sample size reached:
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