Premature infants with respiratory distress syndrome (RDS) may require respiratory support. Because mechanical ventilation (by endoteracheal ventilation) is associated with morbidity, the trend today is to minimize the use of mechanical ventilation. Nasal intermittent positive pressure ventilation (NIPPV) and nasal continuous positive airway pressure (NCPAP) are non invasive treatment for RDS. Application of NCPAP and NIPPV are associated with benefits in terms of reduced respiratory failure, reduced complications, and mortality, in neonates with RDS. We aim to determine whether NCPAP and NIPPV would have different survival rate and possible complications. This prospective clinical trial performs on 120 neonates with RDS. All consecutively born preterm infants with gestational age between 28 to 36 weeks, admitting to Afzalipour neonatal intensive care unit, Kerman, Iran, with respiratory distress and silverman-Anderson retraction score of 6 and 7 are included. Babies are excluded if there is significant morbidity except respiratory distress. The randomization is performed applying minimization technique with respect to baby’s gender and birth weight and the newborn will put in NCPAP or NIPPV 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 and IVH.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202273250N6
Registration date:2012-03-12, 1390/12/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-12, 1390/12/22
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 Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and complications of NIPPV vs NCPAP in preterm infants with respiratory distress admitted in NICU
Public title
Comparison of efficacy and complications of Nasal intermittent positive pressure ventilation (NIPPV) and nasal continuous positive airway pressure (NCPAP) in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All consecutively born preterm infants with gestational age 28 to 36 weeks, admitted to Afzalipour neonatal intensive care unit with respiratory distress and silverman- Anderson retraction score of 6 and 7. Exclusion criteria: Babies were excluded if there was signiicant morbidity apart from RDS including cardiac disease, congenital malformation including congenital diapheragmatic hernia, tracheoeso phageal fistula and cleft lip/palate, babies with respiratory distress secondary to severe asphyxia (Apgar score <3 at 1 and 5 minute or PH<7/12 or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventriculare hemorrhage (IVH) on admission.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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 medical sciences
Street address
kerman University of medical science, Jomhoori blvd
City
Kerman
Postal code
Approval date
2012-01-12, 1390/10/22
Ethics committee reference number
K-90/328
Health conditions studied
1
Description of health condition studied
respiratory distress in neonates
ICD-10 code
p22,p22.0,
ICD-10 code description
Respiratory distress syndrome of newborns
Primary outcomes
1
Description
Response to treatment
Timepoint
During hospitalization and using NCPAPand NIPPV
Method of measurement
comparing survival rates
Secondary outcomes
1
Description
Incidence of pneumothorax
Timepoint
During hospitalization and using NCPAPand NIPPV
Method of measurement
Taking chest x rays on admission and deterioration of clinical status
2
Description
Incidence of PDA
Timepoint
During hospitalization and using NCPAPand NIPPV
Method of measurement
Echo cardiography on admission and deterioration of clinical status
3
Description
Incidence of IVH
Timepoint
During hospitalization and using NCPAPand NIPPV
Method of measurement
Cranial ultra sonography on admission and deterioration of clinical status
Intervention groups
1
Description
Intervention: ventilatory NIPPV
Category
Treatment - Devices
2
Description
Intervention: ventilatory NCPAP
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Medical Center
Full name of responsible person
Reza Mahdian Jouybari
Street address
Mostafa Khomeini blvd
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman university of medical sciences
Full name of responsible person
Reza Mahdian Jouybari
Street address
jomhoori blvd
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
Reza Mahdian Jouybari
Position
Fellowship in neonatology
Other areas of specialty/work
Street address
Afzalipour Medical Center, Mostafa Khomeini blvd
City
Kerman
Postal code
7616913911
Phone
+98 341322225060
Fax
+98 34 1322 2763
Email
reza.mj98@yahoo.com
Web page address
www.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Bahman Bijari
Position
Neonatologist, assistant professor
Other areas of specialty/work
Street address
Afzalipour hospital, Mostafa khomeini blvd
City
Kerman
Postal code
7616913911
Phone
+98 341322225060
Fax
+98 34 1322 2763
Email
bbbijari@kmu.ac.ir
Web page address
www.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Bahman Bijari
Position
Neonatologist, Assistant professor
Other areas of specialty/work
Street address
Afzalipout hospital, Mostafa khomeini BLV
City
Kerman
Postal code
7616913911
Phone
+98 341322225060
Fax
+98 34 1322 2763
Email
bbbijari@kmu.ac.ir
Web page address
www.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)