Respiratory distress syndrome is the most common cause of death in premature infants. One of the methods used in the treatment of neonatal respiratory distress syndrome is a continuous positive airway pressure. This is a randomized clinical trial was performed on 40 premature infants. The study population were preterm infants (34-28 weeks gestation) admitted in neonatal intensive care unit of the Shahid Sadoghi hospital. 20 people numbers were calculated for each group of infants was randomly allocated to either the intervention group (Bubble CPAP) or control (standard CPAP). Infants in both groups were followed up for the time required mechanical ventilation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014032716870N2
Registration date:2014-04-19, 1393/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Khadije Nasiriani
Name of organization / entity
Yazd Shahid Sadoughi University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1755
Email address
nasiriani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences.
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bubble CPAP standard CPAP for treatment of respiratory distress syndrome in premature infants
Public title
Continuous positive airway pressure in premature infants with respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with a gestational age of 28 to 34 weeks with respiratory distress syndrome
Exclusion criteria:
Life-threatening congenital malformations
Severe asphyxia
Sepsis
hematocrit less than 35
Intracranial hemorrhage and intraventricular hemorrhage grade three or four
Age
To 1 year old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Shahid Sadoughi University of Medical Sciences
Street address
Central Buillding of University ,Bahonar Square
City
yazd
Postal code
Approval date
2012-05-07, 1391/02/18
Ethics committee reference number
257428
Health conditions studied
1
Description of health condition studied
respiratory distress syndrome of preterm neonates
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Duration of mechanical ventilation
Timepoint
daily
Method of measurement
Registration time day
Secondary outcomes
empty
Intervention groups
1
Description
Group Intervention: The intervention group infants
The use of continuous positive airway pressure ventilation Bubble
Construction of the New Zealand company Fisher Vpykl
The total duration of the study.
Category
Treatment - Devices
2
Description
Control group: The control group infants using:
Continuous positive airway pressure ventilation standard
Model Bear750psv Made in America
During the whole period of study
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Khadijeh Nasiriani
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Fatemah Ezoddini
Street address
Deputy for research, Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery ,Buali st, Safaieh
City
yazd
Postal code
Phone
+98 35 1824 1755
Fax
Email
nasiriani@gmail.com; nasiriani@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences
Full name of responsible person
Mahmood Noori-Shadkam
Position
Pediatrics/Associate Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital , Reyazi Sq, Safaeye
City
yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
mahmood_7072005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
Nursing PhD
Other areas of specialty/work
Street address
School of Nursing Midwifery,Buali street, Safaieh
City
yazd
Postal code
Phone
+98 35 1824 1755
Fax
Email
nasiriani@gmail.com; nasiriani@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)