Comparison of efficacy and complications of bubble –CPAP with Ventilatory –CPAP in preterm infants with respiratory distress admitted in NICU Afzalipour Medical Center, Kerman, Iran.
Application of continuous positive airway pressure (CPAP) is associated with benefits in terms of reduced respiratory failure, reduced complications and mortality, in neonates with respiratory distress. Bubble CPAP (B-CPAP) and Ventilator-derived CPAP (V-CPAP) are two of the most popular CPAP modes. We aim to determine whether B-CPAP and V-CPAP would have different survival rate and possible complications.
This prospective clinical trial performs on 50 neonates with respiratory distress. All consecutively born preterm infants with birth weight between 1000 to 2000 grams, admiting to Afzalipour neonatal intensive care unit with respiratory distress and Silverman-Anderson retraction score of 6 and 7 are included. Babies are excluded if there is significant morbidity except respiratory disress. The randomization is performed applying minimization technique with respect to baby's gender and birth weight (<1500 versus >1500 grams) and the newborn will put in bubble CPAP or ventilatory CPAP group. The main outcome of this study is lack of response to treatment in regard to survival rates. We will also compare treatment options in terms of duration of oxygen therapy, duration of hospital stay, and hospitalization costs.
We will also assess the incidence of neonatal morbidities in 2 treatment groups: pneumothorax, PDA, IVH, chronic lung disease (CLD), and trauma to nasal septum and nostrils.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902083250N2
Registration date:2010-05-11, 1389/02/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-11, 1389/02/21
Registrant information
Name
Bahareh Bahman Bijari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
bbbijari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Science
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and complications of bubble –CPAP with Ventilatory –CPAP in preterm infants with respiratory distress admitted in NICU Afzalipour Medical Center, Kerman, Iran.
Public title
Comparison of efficacy and complications of bubble –CPAP with Ventilatory –CPAP in preterm infants with respiratory distress admitted in NICU Afzalipour Medical Center, Kerman, Iran.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All consecutively born preterm infants with birth weight between 1000 to 2000 grams, admitted to Afzalipour neonatal intensive care unit with respiratory distress and Silverman-Anderson retraction score of 6 and 7 were included.
Exclusion criteria: Babies were excluded if there was significant morbidity apart from RDS including cardiac diseasse, congenital malformation including congenital diapheragmatic hernia, tracheoesophageal fistula and cleft lip/palate; babies with respiratory distress secondary to severe asphyxia (Apgar score<3 at 1&5 minute or PH<7.12) or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (IVH) on admission.
Age
To 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kerman University of Meical sciences
Street address
Jomhoori BLV- Kerman University of Medical Sciences
City
Kerman
Postal code
Approval date
2010-04-10, 1389/01/21
Ethics committee reference number
K-88/235
Health conditions studied
1
Description of health condition studied
Treatment
ICD-10 code
P22, P22.0
ICD-10 code description
Respiratory distress syndrom of newborns
Primary outcomes
1
Description
Response to treatment
Timepoint
During hospitalization and using CPAP
Method of measurement
Comparing survival rates
Secondary outcomes
1
Description
Incidence of pneumothorax
Timepoint
During hospitalization and using CPAP
Method of measurement
Taking chest X rays on admission and deterioration of clinical status
2
Description
Incidence of PDA
Timepoint
During hospitalization and using CPAP
Method of measurement
Echocardiography on admission and deterioration of clinical status
3
Description
Incidence of IVH
Timepoint
During hospitalization and using CPAP
Method of measurement
Cranial Ultrasonography on admission and deterioration of clinical status
4
Description
Incidence of chronic lung disease
Timepoint
During hospitalization
Method of measurement
Taking chest X rays on admission and winning
5
Description
Incidence of trauma to nasal septum and nostrils
Timepoint
During using Cpap
Method of measurement
Physical examination by an expert neonatalogist
Intervention groups
1
Description
Intervention-Bubble CPAP
Category
Treatment - Devices
2
Description
Intervention- Ventilatory CPAP
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Medical Center
Full name of responsible person
Arash Malekian
Street address
Mostafa Khomeini BLV, Afzalipour Medical Center
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Arash Malekiyan
Street address
Jomhoori BLV- Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical sciences
Full name of responsible person
Arash Malekiyan
Position
Fellowship in Neonatalogy
Other areas of specialty/work
Street address
Afzalipour hospital, Mostafa Khomeini BLV
City
Kerman
Postal code
Phone
+98 34 1322 2269
Fax
Email
malekianarash@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Bahman Bijari
Position
Neonatalogist-Assisatant professor
Other areas of specialty/work
Street address
Afzalipour hospital- Mostafa Khomeini BLV
City
Kerman
Postal code
Phone
+98 34 1322 2269
Fax
Email
bbbijari@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Bahman Bijari
Position
Neonatalogist-Assistant professor
Other areas of specialty/work
Street address
Afzalipour hospital- Mostafa Khomeini BLV
City
Kerman
Postal code
Phone
+98 34 1322 2269
Fax
Email
bbbijari@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)