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.
-
Intervention groups
-
Intervention group 1: 200 mg/kg intratracheal Curosurf surfactant (Chiesi Farmaceutici, Parma, Italy). Intervention group 2: 135 mg/kg intratracheal BLES surfactant (BLES Biochemicals Inc., Ontario, Canada).
-
Main outcome variables
-
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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-04-09, 1397/01/20
-
Ethics committee reference number
-
IR.KAUMS.MEDNT.REC.1397.003
Health conditions studied
1
-
Description of health condition studied
-
Respiratory distress syndrome of newborn
-
ICD-10 code
-
P22
-
ICD-10 code description
-
Respiratory distress of newborn
Primary outcomes
1
-
Description
-
The number of surfactant injection
-
Timepoint
-
After the intervention
-
Method of measurement
-
Checklist
Secondary outcomes
1
-
Description
-
Length of oxygen dependency
-
Timepoint
-
After the intervention
-
Method of measurement
-
Checklist
2
-
Description
-
Duration of hospital stay.
-
Timepoint
-
After the intervention
-
Method of measurement
-
Checklist
3
-
Description
-
Complications of prematurity
-
Timepoint
-
After the intervention
-
Method of measurement
-
Checklist
Intervention groups
1
-
Description
-
Intervention group 1: 200 mg/kg intratracheal Curosurf surfactant (Chiesi Farmaceutici, Parma, Italy).
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention group 2: 135 mg/kg intratracheal BLES surfactant (BLES Biochemicals Inc., Ontario, Canada).
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kashan 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
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