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 (Variable CPAP). Respiratory condition, including duration of continuous positive airway pressure, duration of mechanical ventilation and duration of oxygen therapy was considered as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081918862N1
Registration date:2014-09-27, 1393/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-27, 1393/07/05
Registrant information
Name
Mohsen Karimi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1725 8770
Email address
dr.m.karimi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-04-05, 1392/01/16
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Bubble CPAP with Variable CPAP in respiratory distress syndrome in preterm infants
Public title
Continuous positive airway pressure in premature infants with respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age of 28-34 weeks; Birth weight 1000-2400 g; Respiratory distress syndrome; Respiratory score 5-7 under the Table Silverman Anderson
Exclusion criteria: Infants with congenital malformations including congenital heart disease, congenital diaphragmatic hernia, esophageal atresia, cleft lip and palate, Gastrochesia, emphalocele and gastrointestinal obstruction ; Moderate to severe asphyxia (II,III); Clinical signs of infection; Hematocrit less than 35; ICH , IVH (III.IV); Lack of parental consent
Age
To 1 year old
Gender
Both
Phase
N/A
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
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Square, Yazd
City
Yazd
Postal code
Approval date
2014-01-07, 1392/10/17
Ethics committee reference number
259875
Health conditions studied
1
Description of health condition studied
respiratory distress syndrome of preterm neonates
ICD-10 code
P22
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Duration of CPAP
Timepoint
12 to 24 hour and during daily visits
Method of measurement
PEEP Pressure , Fio2
2
Description
Duration of mechanical ventilation
Timepoint
12 to 24 hour and during daily visits
Method of measurement
PIP , Fio2 , PEEP , RR
3
Description
Duration of Oxygen with Hood
Timepoint
12 to 24 hour and during daily visits
Method of measurement
Fio2
Secondary outcomes
1
Description
incidence of complications ( IVH,PDA,Pneumothorax)
Timepoint
Daily until discharge
Method of measurement
IVH with brain sonography, PDA with echocardiography,Pneumothorax with CXR or transilumination
2
Description
Weight gain at discharge
Timepoint
Daily until discharge
Method of measurement
scale
3
Description
Duration of Hospitalization
Timepoint
Daily until discharge
Method of measurement
date
4
Description
Death
Timepoint
Daily until discharge
Method of measurement
Physical exam
Intervention groups
1
Description
CPAP by under water Bubble CPAP system (Fisher & Paykel Healthcare, Auckland 2013 Panmure, Auckland 1741 New Zealand)
Category
Treatment - Devices
2
Description
NCPAP with Medijet (Medijet active NCPAP Generator, Medin Innovations GmbH Lindberghstrasse Ikaruspark D - 82178 Puchheim)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Mahmood Noori Shadkam - Neonatalogist
Street address
Shahid Sadoughi Hospital, Avenue Ibn Sina, Shahid Ghandi Boulevard, Atlasi Square, Yazd
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
Shahid Sadoughi University of Medical Sciences Central Building, Shahid Bahonar Square, Yazd
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
Dr Mohsen Karimi
Position
Pediatrics Assistant
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences Central Building, Shahid Bahonar Square, Yazd
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
Email
mohsensr853@Yahoo.Com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Mahmoud Noori Shadkam
Position
Neonatalogist
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences Central Building, Shahid Bahonar Square, Yazd
City
Yazd
Postal code
Phone
+98 35 1724 0171
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
Dr Mohsen Karimi
Position
Pediatrics Assistant
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences Central Building, Shahid Bahonar Square, Yazd
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
Email
mohsensr853@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)