Comparison of two methods of respiratory support: Nasal Continuous positive Airway Pressure (NCPAP) and Nasal Intemitant Positive Pressure Ventilation (NIPPV) after less invasive surfactant administration (LISA) in preterm infants 28 to 36 weeks of age with respiratory distress syndrome, a Randomized clinical trial
Comparison of two methods of respiratory support: NCPAP and NIPPV after less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome
Design
Sample size will be 96 people in two equal groups of 48 people, randomization using sealing envelope method without replacement, The person evaluating the outcome will not know the type of intervention ( single blind)
Settings and conduct
This study will be performed in the neonatal intensive care unit of Fatemieh Hospital in Hamadan. In this study, eligible infants will be randomly assigned to one of the NCPAP or NIPPV.
NCPAP Group will apply continuous airway pressure through a mask or nose pendulum with 4 cm of water pressure and 40% fraction of inspired oxygen.
When saturation 4 cm water, , FIO2 less than 30% and oxygen saturation 90 to 94% achieved, CPAP will be disconnected and the patient will be under oxygen therapy with oxy hood.
NIPPV group will be ventilated with Nasal Intemitant Positive Pressure through the nose. By improving the quality of the baby's oxygen supply, we gradually reduce the PIP by 2 cm to 14 cm. Then the respiratory rate will be reduced by 5 to 10 per minute Until spontaneous breathing increases
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 28 to 36 weeks gestational age, respiratory distress syndrome, Fractional Inspired Oxygen (Fio2)>40 and need to treatment with surfactant in less than 24 hours after birth.
Exclusion Criteria: congenital heart disease, other major congenital anomalies
Intervention groups
Intervention group:
Under ventilation with continuous positive airway pressure through the nose with maximum pressure
control group:
Nasal Intemitant Positive Pressure Ventilation through a mask or nose pendulum
Main outcome variables
need to respiratory support and ventilation within a week, hospital stay and mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N9
Registration date:2020-06-19, 1399/03/30
Registration timing:retrospective
Last update:2020-06-19, 1399/03/30
Update count:0
Registration date
2020-06-19, 1399/03/30
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
2020-01-15, 1398/10/25
Actual recruitment end date
2020-04-19, 1399/01/31
Trial completion date
2020-05-04, 1399/02/15
Scientific title
Comparison of two methods of respiratory support: Nasal Continuous positive Airway Pressure (NCPAP) and Nasal Intemitant Positive Pressure Ventilation (NIPPV) after less invasive surfactant administration (LISA) in preterm infants 28 to 36 weeks of age with respiratory distress syndrome, a Randomized clinical trial
Public title
Treatment of respiratory distress syndrome in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age of 28-37 weeks
With distress syndrome
Fraction of inspired oxygen>40
Require treatment with surfactant in less than 24 hours after birth
Exclusion criteria:
APGAR score<5
Suffering from any congenital disease
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
96
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
We will provide 96 cards and will write letter I on 48 for intervention and on the other 48 letter C for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, randomly select one of the envelopes and open it, based on selected letter ( I or C) patients assign it to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the outcome will be unaware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
ُShahid Fahmideh Vvenue
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.UMSHA.REC.1398.866
Health conditions studied
1
Description of health condition studied
neonatal respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
respiratory support
Timepoint
First week of birth
Method of measurement
Investigation of FIO2 and analysis of arterial blood gases
Secondary outcomes
1
Description
hospitalization duration
Timepoint
From hospitalization to discharge
Method of measurement
Review of infant medical records
2
Description
mortality
Timepoint
From hospitalization to discharge
Method of measurement
Review of infant medical records
Intervention groups
1
Description
Intervention group: Nasal Intermittent Positive Pressure Ventilation (NIPPV) after less invasive surfactant administration (LISA). This group intermittently will expose to higher levels of air pressure through the same device attached to the nose. Maximum Respiratory Pressure Group (PIP) receives 18-20 cm H2O, PEEP 5-6 cm H2O, respiratory rate 30-40 per minute, Inhalation time 0.35-0.40 seconds, flow rate 6-8 liters per minute.
Category
Treatment - Devices
2
Description
Control group: Nasal Continuous positive Airway Pressure (NCPAP). This Group will apply continuous airway pressure through a mask or nose pendulum with 4 cm of water pressure and 40% fraction of inspired oxygen. When saturation 4 cm water, , FIO2 less than 30% and oxygen saturation 90 to 94% achieved, CPAP will be disconnected and the patient will be under oxygen therapy with oxy hood. By improving the quality of the baby's oxygen supply, we gradually reduce the PIP by 2 cm to 14 cm. Then the respiratory rate will be reduced by 5 to 10 per minute Until spontaneous breathing increases
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Mohammad Kazem Sabzehei
Street address
Pasdaran
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 1827 7459
Fax
+98 81 1828 3939
Email
fatemieh@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD