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Trial registered on ANZCTR


Registration number
ACTRN12613000346774
Ethics application status
Approved
Date submitted
13/03/2013
Date registered
2/04/2013
Date last updated
2/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non Invasive Positive Pressure Ventilation (NIPPV) or conventional mechanical ventilation for neonatal respiratory failure
Scientific title
Non Invasive positive pressure ventilation( NIPPV )or conventional mechanical ventilation for treatment of respiratory failure and CPAP failure in premature infants hospitalized in Alzahra and Shahid behesthi hospitals in Isfahan.
Secondary ID [1] 282113 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory failure 288607 0
Condition category
Condition code
Respiratory 288940 288940 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 288988 288988 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasal intermittent positive pressure ventilation (NIPPV) involves giving continuous positive airway pressure (CPAP) to the infant in the intermittent mandatory ventilation (IMV) mode that have advocated as a means to wean infants from mechanical ventilation(by nasal root).We have found NIPPV more effective than nasal continuous positive airway pressure(NCPAP) in weaning infants with RDS from mechanical ventilation and have recommended that NIPPV be used as the modality of choice for extubation.because mechanical ventilation (by endoteracheal ventilation) is associated with high morbidity,today an effort to decrease ventilator induced lung injury,alternative techniques of ventilation have been employed.we administered NIPPV when the patient have CPAP failure and it will continue till wean from NIPPV(with frequent arterial blood gass(ABG).We will also assess the incidence of complications such as pneumothorax, intra ventricular hemorrhage(IVH), broncho pulmonary dysplasia(BPD), necrotizing enterocolitis(NEC) and patient dactus arteriosus(PDA) in our trial.
Intervention code [1] 286714 0
Treatment: Devices
Comparator / control treatment
Conventional mechanical ventilation (CV) is a modality that paitients with respiratory failure and CPAP failure intubated and then connected to to ventilator with IMV mode.It will continue untill with frequent ABG,we could wean pateint from ventilator.
Control group
Active

Outcomes
Primary outcome [1] 289068 0
Need for Non invasive positive pressure ventilation or Invasive Ventilatory support(conventional mechanical ventilation) Conversion to NIPPV or CV will be recorded as dichotomous data (yes/no).Descriptive statistics; proportions , will be used to describe the measured parameters for each group. Categorical data will be analysed with Chi2 test or Fishers Exact Test as appropriate. All analysis will be intention-to-treat.
Timepoint [1] 289068 0
During hospitalization and using NIPPV and conventional mechanical ventilation, we will get ABG 1 hour after starting treatment and then every 6 hours until the patient is weaned from the ventilator.
Secondary outcome [1] 301668 0
bronchopulmonary dysplasis(BPD) (yes/no) diagnosed on chest x_ray.
Timepoint [1] 301668 0
during hospital admission
Secondary outcome [2] 301669 0
Intra ventricular hemorrhage(IVH) (yes/no) diagnosed on cranial ultrasonography,will be used to describe the measured parameters for each group
Timepoint [2] 301669 0
In days 1_3 and 7_10 'during hospital admission'.
Secondary outcome [3] 301670 0
Necrotizing enterocolitis (NEC) (yes/no) diagnosed on Bell's criteria,will be used to describe the measured parameters for each group
Timepoint [3] 301670 0
during hospital admission
Secondary outcome [4] 301671 0
pneumothorax (yes/no) diagnosed on chest x_ray, will be used to describe the measured parameters for each group.
Timepoint [4] 301671 0
during hospital admission
Secondary outcome [5] 301672 0
patient dactus arteriosus (PDA) (yes/no) diagnosed on echocardiography, will be used to describe the measured parameters for each group.
Timepoint [5] 301672 0
If patient has the signs and symptoms of PDA 'during hospital admission' echocardiography has done.

Eligibility
Key inclusion criteria
inclusion criteria: All consecutively born preterm infants with gestational age less than 35 weeks and birth weight less than 2500g treated with NCPAP that have CPAP failure (Fio2 more than 60% and max CPAP equal to 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 20,31,35hr).
Minimum age
0 Days
Maximum age
1 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
exclusion criteria: babies were excluded if there was nasopharyngeal pathology including coanal atresia,cleft/lip palate,major anomalies especially thorasic or cardiac anomalies,IVH grade 3 or 4 on admission and their parents refuse to participate in the research project.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4909 0
Iran, Islamic Republic Of
State/province [1] 4909 0
Isfahan

Funding & Sponsors
Funding source category [1] 286880 0
University
Name [1] 286880 0
Isfahan university of medical sciences
Country [1] 286880 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Isfahan university of medical sciences
Address
Isfahan university of medical sciences, Hezarjarib Ave, Isfahan, Iran

Postcode: 81647-2384
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 285671 0
None
Name [1] 285671 0
Address [1] 285671 0
Country [1] 285671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288943 0
Ethics Committee of Isfahan University of Medical Sciences
Ethics committee address [1] 288943 0
Isfahan University of Medical Sciences, Hezarjarib Ave, Isfahan, Iran

Postcode: 81647-2384
Ethics committee country [1] 288943 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 288943 0
Approval date [1] 288943 0
Ethics approval number [1] 288943 0
391369

Summary
Brief summary
RDS and its sequelae BPD, are both frequent complications of prematurity that may requires respiratory support.because mechanical ventilation (by endoteracheal ventilation) is associated with high morbidity,today an effort to decrease ventilator induced lung injury,alternative techniques of ventilation have been employed.NIPPV is a noninvasive approach for ventilation.The benefits of NIPPV use for infants with NCPAP failure is not studied yet.So our purpose is to compare two modalities;NIPPV and conventional ventilation(CV) for treatment of respiratory failure in preterm neonates.This prospective clinical trial performs on 50 patients with GA<35 weeks and Birth Weight <2500g that have CPAP failure and admitted in NICU of Alzahra and Shahid Beheshti hospitals in Isfahan.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,IVH,BPD,NEC and PDA in our trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38442 0
Dr Babak Nekooie
Address 38442 0
Alzahra hospital, Sofe Ave, Isfahan, Iran

Postcode: 817467-5731
Country 38442 0
Iran, Islamic Republic Of
Phone 38442 0
+983116255555
Fax 38442 0
Email 38442 0
[email protected]
Contact person for public queries
Name 38443 0
Babak Nekooie
Address 38443 0
Alzahra hospital, Sofe Ave, Isfahan, Iran

Postcode: 817467-5731
Country 38443 0
Iran, Islamic Republic Of
Phone 38443 0
+983116255555
Fax 38443 0
Email 38443 0
[email protected]
Contact person for scientific queries
Name 38444 0
Zohreh Badiei
Address 38444 0
Alzahra hospital, Sofe Ave, Isfahan, Iran

Postcode: 817467-5731
Country 38444 0
Iran, Islamic Republic Of
Phone 38444 0
+983116255555
Fax 38444 0
Email 38444 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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