Comparison of duration of NCPAP؛ CPAP level؛ Duration of hospitalization؛ Need for mechanical ventilation؛ Incidence of BPD؛ Incidence of air leak syndrome؛ Duration for full enteral feeding؛ Number of surfactant administration
Design
Two arm parallel group randomised trial with outcome assessment on 136 preterm newborns
Settings and conduct
The study was conducted on preterm newborns affiliated from RDS in hospitals dependent to Isfahan University of Medical Sciences
Participants/Inclusion and exclusion criteria
This study was a randomized clinical trial on 136 preterm newborns with gestational age between 30 to 34 week affiliated with RDS hospitalized in centers dependent to Isfahan University of Medical Sciences and need for respiratory support via NCPAP.
Intervention groups
Newborns in control group receive NCPAP in supine position and surfactant administrate using INSURE technique according to the definitive criteria.newborns in case group receive NCPAP in prone position and only for feeding and routine care position change to supine and if time of supine position last more than 3 hours per day exit from study . In two groups the manner of surfactant administration and weaning are same.
Main outcome variables
Duration of NCPAP؛ CPAP level؛ Duration of hospitalization؛ Need for mechanical ventilation؛ Incidence of BPD؛ Incidence of air leak syndrome؛ Duration for full enteral feeding؛ Number of surfactant administration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150423021910N6
Registration date:2020-10-18, 1399/07/27
Registration timing:retrospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Behzad Barekatain
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6670
Email address
b_barekatain@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2020-09-21, 1399/06/31
Trial completion date
2020-09-21, 1399/06/31
Scientific title
Comparison of the Effect of Supine and Prone Position on duration of respiratory support in Premature newborns with RDS receiving NCPAP
Public title
Effect of Position on duration of respiratory support in Premature newborns with RDS receiving NCPAP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 30 to 34 W
Affiliated from RDS
Mother received one course of steroid therapy before delivery
Exclusion criteria:
Lack of Congenital Heart Disease
Lack of Defects interfere with specific position
Lack of Perinatal Asphyxia
Lack of maternal chorioamnionitis
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Actual sample size reached:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple and individuals.table of random numbers use to randomization. at first one row and one column selected randomly and conflux point of row and column was consider as initial point of sampling. then top down even numbers and odd numbers accrue to case and control groups respectively.for allocation concealment 136 envelopes prepare and random numbers register .after closure of envelopes, we put those into the box.according to the order of patients one of the envelopes open and patients allocate to case or control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerib boulevard, Isfahan University of Medical Sciense, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.MUI.REC.1396.1.142
Health conditions studied
1
Description of health condition studied
Respiratory Distress Syndrom
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Duration of CPAP
Timepoint
Hour
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Mean of CPAP
Timepoint
During study
Method of measurement
CPAP desktop
2
Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Questionnaire
3
Description
Need for mechanical ventilation
Timepoint
During study
Method of measurement
Clinical examination
4
Description
Bronchopulmonary dysplasia
Timepoint
During study
Method of measurement
Clinical examination
5
Description
Pneumothorax
Timepoint
During study
Method of measurement
Chest X ray
6
Description
Time to full enteral feeding
Timepoint
During study
Method of measurement
Clinical examination
7
Description
The number of surfactant administration
Timepoint
During study
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: The newborns in case group put in prone position and only for feeding and nurse care position change to supine for maximum 15 minute. respiratory support was established with NCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand); at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. In case, the newborn needed inspiratory oxygen fraction of higher than 40% to maintain oxygen saturation in the right hand at 90–95% for more than 1 hour, the newborn would receive 200 mg/kg of Crusorf per INSURE method. In case, the newborn’s need for the inspiratory oxygen fraction of higher than 40% was consistent to maintain the oxygen saturation level in an acceptable range,after 12 h from the last administration of surfactant,Crusorf (100 mg/kg) would be administered again, and as necessary,the full course of treatment (maximum 3 dose) would be observed.after stabilization under CPAP for more than 12 hour, CDP decrease every 4 hour and in the setting as CDP=4 cmH2O and FiO2<25% newborn wean from NCPAP.
Category
Treatment - Devices
2
Description
Control group: The newborns in control group put in supine position. respiratory support was established with NCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand); at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. In case, the newborn needed inspiratory oxygen fraction of higher than 40% to maintain oxygen saturation in the right hand at 90–95% for more than 1 hour, the newborn would receive 200 mg/kg of Crusorf per INSURE method. In case, the newborn’s need for the inspiratory oxygen fraction of higher than 40% was consistent to maintain the oxygen saturation level in an acceptable range,after 12 h from the last administration of surfactant,Crusorf (100 mg/kg) would be administered again, and as necessary,the full course of treatment (maximum 3 dose) would be observed.after stabilization under CPAP for more than 12 hour, CDP decrease every 4 hour and in the setting as CDP=4 cmH2O and FiO2<25% newborn wean from NCPAP.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Barekatain
Street address
Sofeh street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
b_barekatain@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Behzad Barekatain
Street address
Metal Bridge, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3236 7001
Email
b_barekatain@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezarjerib boulevard, Isfahan University of Medical Sciense, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 3405
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?