Our purpose is to compare two modalities; Nasal intermittent positive ventilation (NIPPV) and conventional ventilation (CV) for treatment of respiratory failure in preterm neonates. This prospective clinical trial performs on 50 patients with gestational age less than 35 weeks and Birth Weight less than 2500 grams that have continuous positive airway pressure (CPAP) failure and admitted in NICU of Alzahra and Shahid Beheshti hospitals in Isfahan that they excluded by nasopharyngeal pathology; coanal atresia; cleft/lip palate; major anomalies especially thorasic or cardiac anomalies; intra ventricular hemorrhage (IVH) grade 3 or 4 on admission; their parents refuse to participate in the research project. . The randomization is performed applying minimization technique with respect to baby's gender and Birth weight and the newborns will devided into two groups; NIPPV and CV. We will also assess the incidence of complications such as pneumothorax, intra ventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) and patient dactus arteriosus (PDA) in our trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011412132N1
Registration date:2013-03-24, 1392/01/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-24, 1392/01/04
Registrant information
Name
Babak Nekooie
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1627 3077
Email address
b_nekooie@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-11-28, 1391/09/08
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Nasal intermittent positive ventilation (NIPPV) or conventional mechanical ventilation for treatment of neonatal respiratory failure
Public title
Nasal intermittent positive ventilation (NIPPV) or conventional mechanical ventilation for neonatal respiratory failure
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: getational age less than 35 weeks; birth weight less than 2500 grams; CPAP failure (Fio2 more than 60% and maximum CPAP 8 cmH2O and/or PH less than 7.2 and PCO2 more than 60 and/or more than 3 episodes apnea with bradicardia (heart rate less than 80 per minute in 20,31,35 hours).
exclusion criteria: nasopharyngeal pathology; coanal atresia; cleft/lip palate; major anomalies especially thorasic or cardiac anomalies; intra ventricular hemorrhage (IVH) grade 3 or 4 on admission; their parents refuse to participate in the research project.
Age
To 1 year old
Gender
Both
Phase
N/A
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
81577_2342
Approval date
2012-11-28, 1391/09/08
Ethics committee reference number
391369
Health conditions studied
1
Description of health condition studied
Respiratory failure of newborns
ICD-10 code
p28.5
ICD-10 code description
Respiratory failure of newborns
Primary outcomes
1
Description
response to treatment
Timepoint
during hospitalization and using NIPPV and conventional mechanical ventilation
Method of measurement
comparing survival rates according to serial arterial blood gass (ABG) sampling.
Secondary outcomes
1
Description
incidence of bronchopulmonary dysplasia (BPD)
Timepoint
during hospitalization and using NIPPV and conventional mechanical ventilation
Method of measurement
Taking CXR on addmission and weaning
2
Description
incidence of intra ventricular hemorrhage (IVH)
Timepoint
during hospitalization and using NIPPV and conventional mechanical ventilation
Method of measurement
cranial ultrasonography on addmission and deterioration of clinical statys
3
Description
incidence of patient dactus arteriosus (PDA)
Timepoint
during hospitalization and using NIPPV and conventional mechanical ventilation
Method of measurement
Echocardiography on addmission and deterioration of clinical status
4
Description
incidence of necrotizing enterocolitis (NEC)
Timepoint
during hospitalization and using NIPPV and conventional mechanical ventilation
Method of measurement
According to Bell's criteria
5
Description
incidence of pneumothorax
Timepoint
during hospitalization and using NIPPV and conventional mechanical ventilation
Method of measurement
Taking CXR on addmission and deterioration on clinical status
Intervention groups
1
Description
Nasal intermittent positive pressure ventilation (NIPPV) involves giving continuous positive airway pressure (CPAP) to the infant in the intermittent mandatory ventilation (IMV) mode.
Category
Treatment - Devices
2
Description
Conventional mechanical ventilation is a methode of ventilation that paitient have endotheracheal intubation and and connect to ventilator by that.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Babak Nekooie
Street address
Alzahra hospital, Sofe blvd, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Babak Nekooie
Street address
Shahid Beheshti hospital, Motahari blvd, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zohreh Badiei
Street address
Isfahan University of Medical Sciences, Hezarjarib Ave, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Babak Nekooie
Position
fellowship in neonatology
Other areas of specialty/work
Street address
Alzahra hospital, Sofe blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
b_nekooie@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zohreh Badiei
Position
Neonatology, Assistant professor
Other areas of specialty/work
Street address
Alzahra hospital, sofe blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
badiei@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zohreh Badiei
Position
Neonatologist, Assistant professor
Other areas of specialty/work
Street address
Alzahra hospital, Sofe blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
badiei@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)