This study was conducted to compare two NCPAP(nasal continuous positive airway pressure) and NIPPV (nasal intermittent positive pressure ventilation) methods in infants with respiratory distress syndrome (RDS). Patients with gestational ages of less than 34 weeks, birthweight of less than 1800 gr, respiratory distress despite receiving Surfactant and mechanical ventilation were included in the study. Infants with anomalies in nasopharyngeal path, heart or lungs were excluded from the trial.
After primary care and extubation infants were randomly allocated to two groups; first group underwent respiratory support by NCPAP using small mask and the second group received NIPPV using nasal prongs. Demographic information as well as required duration of hospitalization, oxygen therapy, respiratory protection, need for re-intubation and complications were recorded in a pre-designed checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050517413N25
Registration date:2017-06-12, 1396/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-12, 1396/03/22
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of NCPAP and NIPPV in premature infants with RDS after extubation in NICU ward of Najmiyeh Hospital
Public title
Comparing the effectiveness of two mask and nasal tube ventilation methods in premature infants with respiratory failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:gestational ages of less than 34 weeks ; birthweight of less than 1800 gr; respiratory distress despite receiving Surfactant and mechanical ventilation; needed FIO2 of less than 60% after extubation
Exclusion criteria:anomalies in nasopharyngeal path, heart or lungs; chromosomal anomalies; intraventricular hemorrhage (IVH); not willing to participate
Age
To 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Baqiyatallah University of Medical Sciences
Street address
Nosrati ave., South Sheykh Bahaei, Mollasadra st., Vanaq sq., Tehran
City
Tehran
Postal code
Approval date
2016-08-01, 1395/05/11
Ethics committee reference number
IR.BMSU.REC.1395.174
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Duration of ventilation
Timepoint
After intervention
Method of measurement
Time record by nurse
2
Description
Oxygen Saturation
Timepoint
After intervention
Method of measurement
Pulse Oxymetry
3
Description
Arterial oxygen pressure
Timepoint
After intervention
Method of measurement
Arterial Blood Gas Assessment
4
Description
Respiratory rate
Timepoint
After intervention
Method of measurement
one minute counting by nurse
Secondary outcomes
1
Description
Abdominal Distention
Timepoint
After intervention
Method of measurement
Physical examination
2
Description
Mortality
Timepoint
After intervention
Method of measurement
Recording mortality cases
3
Description
Intraventricular hemorrhage
Timepoint
After intervention
Method of measurement
Brain sonography
4
Description
Necrotizing Enterocolitis
Timepoint
After intervention
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group:
Ventilation by NCPAP
Category
Treatment - Other
2
Description
Control group:
Ventilation by NIPPV
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Najmiyeh Hospital
Full name of responsible person
Bita Najafian
Street address
Hafez, Jomhouri st., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran