Early nasal intermittent positive pressure ventilation versus continuous positive airway pressure in preterm infants with respiratory distress syndrome
The aim of this study was to compare the prognosis and side effects in premature neonates with gestational age between 28 to 34 weeks at Fatemiyeh Hospital affiliated to Hamedan University of Medical Science with respiratory distress syndrome that are treated with nasal intermittent positive pressure ventilation or nasal continuous positive airway pressure. This clinical trial was performed on sixty premature neonates with birth weight between 1000 to 2000 grams with respiratory distress within 6 hours of birth and 2 or more of symptoms of respiratory distress or Silverman-Anderson score of 6 or 7 were eligible and patients are classified into 2 groups. The subjects were randomly assigned in two groups to receive early nasal continous positive airway pressure and early nasal intermittent positive pressure ventilation. All newborns were observed for seven days about the need for mechanical ventilation, adverse outcomes and death. In these time pneumothorax, patent ducts steroids (PDA), lung hemorrhage, disseminated intravascular coagulopathy (DIC), icterus, sepsis was determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072618598N1
Registration date:2015-09-25, 1394/07/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-25, 1394/07/03
Registrant information
Name
Mohamad Kazem Sabzehei
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 2803
Email address
mk.sabzehei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early nasal intermittent positive pressure ventilation versus continuous positive airway pressure in preterm infants with respiratory distress syndrome
Public title
Comparison of non-invasive treatment through the nose for the treatment of respiratory immaturity in preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
All consecutively born preterm infants with gestational age between 28 to 34 weeks, admitted to Fatemiyeh neonatal intensive care unit with respiratory distress syndrome
Inclusion criteria: approved RDS; gestational age between 28 to 34 weeks; neonates with 72 hours age after delivery.
Exclusioncriteria: the neonates aith APGAR score less than 3 at five minute after birth; those whom mother had rupture of the membrane for more than three weeks; severe malformation; chromosomal anomalies such as trisomy of 13,18 and 21; pneumonia; pneumothorax
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Hamedan University of Medical Sciences
Street address
Hamedan university of medical science, Daneshgah street, Pajohesh square
City
Hamedan
Postal code
Approval date
2014-11-25, 1393/09/04
Ethics committee reference number
4201/9/35/16/پ
Health conditions studied
1
Description of health condition studied
treatment
ICD-10 code
p22, p22.0
ICD-10 code description
Respiratory distress of newborn
Primary outcomes
1
Description
survival rates in 7days
Timepoint
during hospitalization and using NIPPV and NCPAP
Method of measurement
comparing survival rates
Secondary outcomes
1
Description
need to mechanical ventilation
Timepoint
during hospitalization and using NIPPV and NCPAP
Method of measurement
during hospitalization and using NIPPV and NCPAP
2
Description
lung hemorhage
Timepoint
during hospitalization and using NIPPV and NCPAP
Method of measurement
during hospitalization and using NIPPV and NCPAP
3
Description
pnemothorax
Timepoint
during hospitalization and using NIPPV and NCPAP
Method of measurement
during hospitalization and using NIPPV and NCPAP
4
Description
NEC
Timepoint
during hospitalization and using NIPPV and NCPAP
Method of measurement
during hospitalization and using NIPPV and NCPAP
5
Description
sepsis
Timepoint
during hospitalization and using NIPPV and NCPAP
Method of measurement
during hospitalization and using NIPPV and NCPAP
6
Description
mortality
Timepoint
during hospitalization and using NIPPV and NCPAP
Method of measurement
during hospitalization and using NIPPV and NCPAP
Intervention groups
1
Description
Using of early nasal continous positive airway pressure at least 48 hours with the maximum positive end expiratory pressure: 5 cmH2o and Fio2: 60%
Category
Treatment - Other
2
Description
Using of early nasal intermittent positive pressure ventilating at least 48hours with the maximum PEEP: 5 cmH2o, Fio2: 60%, PIP: 16 cmH2o, Resirstory rate: 30/min
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh Hospital
Full name of responsible person
Maryam Nasresfahani
Street address
Hamedan University of Medical Sciences, Daneshgah street, Pajohesh square
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Scinences
Full name of responsible person
Dr Mohamad Yosef Alikhani
Street address
Daneshgah street, Pajohesh square, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Scinences
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
Hamedan University of Medical Sciences
Full name of responsible person
Mohamad Kazem Sabzehei
Position
Neonatologist-assistant professor
Other areas of specialty/work
Street address
Fatemiyeh Hospital, Kermanshah street, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 0749
Fax
Email
Mk_sabzehei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamdan University of Medical Sciences
Full name of responsible person
Mohamad Kazem Sabzehei
Position
Neonatologist- assistant professor
Other areas of specialty/work
Street address
Fatemiyeh Hospital, Kermanshah street, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 0749
Fax
Email
Mk_sabzehei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Mohamad Kazem Sabzehei
Position
Neonatologist- assistant professor
Other areas of specialty/work
Street address
Fatemiyeh Hospital, Kermanshah street, Hamedan
City
Hamedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)