Protocol summary
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Study aim
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Determine the effect of assisted ventilation nasal continuous positive air way pressure versus nasal duo positive air way pressure on the clinical course of neonates with gestational age between 28-34 weeks with respiratory distress syndrome
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Design
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Randomized clinical trial study with parallel groups and blinded ,with sample size of 148 patients
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Settings and conduct
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this study is conducted in neonatal intensive care unit of Ahwaz Imam Hospital .blindness is done on the patient ,the investigator and the data analyst and only the therapist is the administrative.
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Participants/Inclusion and exclusion criteria
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Neonates with gestational age of 28-34 weeks with respiratory distress syndrome(RDS) with RDS score between 6-8 according Silverman-Andersen score ,entrance in study, in the first 6 hours of birth.neonate with meconium aspiration ,diaphragmatic hernia ,major congenital anomaly, air way anomaly,severe cardio-vascular instability,asphyxia,metabolic disorder,parental dissatisfaction,birth outside the hospital studied,start of invasive mechanical ventilation from the beginning of admission,cyanotic heart disease ,and gestational age less than 28 weeks or more than 34 weeks are not included in this study.
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Intervention groups
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In this study, neonates are randomly divided into two group of neonate under nasal continuous positive air way pressure and neonates under nasal duo positive air way pressure
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Main outcome variables
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The primary outcome included failure of non invasive ventilation that requiring
tracheal intubation and mechanical ventilation during 72 hours after entrance to study.secondary outcome included ,intra ventricular hemorrhage ,chronic lung disease ,patent ductus arteriosus ,air leak syndromes ,occurrence apnea,death ,frequency of use of surfactant and duration of admission in two groups.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180821040847N1
Registration date:
2018-09-10, 1397/06/19
Registration timing:
prospective
Last update:
2019-05-04, 1398/02/14
Update count:
1
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Registration date
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2018-09-10, 1397/06/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-23, 1397/07/01
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Expected recruitment end date
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2019-03-21, 1398/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of assisted ventilation using nasal continuous positive air way pressure versus nasal duo positive air way pressure on the clinical course of neonates with gestational age between 28-34 week with respiratory distress syndrome :A randomized controlled trial.
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Public title
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."Effect of nasal continuous positive air way pressure on the clinical course of neonates with respiratory distress syndrome" ."Effect of nasal duo positive air way pressure on the clinical course of neonates with respiratory distress syndrome"
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Preterm neonate with gestational age of 28-34 weeks
With respiratory distress syndrome
With respiratory distress syndrome score of 6-8 according to Silver man-Andersen score
Entrance to study in primary 6 hours of birth
Exclusion criteria:
Major congenital abnormalities
Air way abnormalities
Sever cardio-vascular instability
Sever asphyxia(Apgar score<=3 at minute 1 and minute 5 of birth or potential hydrogen(PH) <=7/1)
Dissatisfaction of parents
Meconium aspiration
Diaphragmatic hernia
Initioation of invasive mechanical ventilation from beginning of hospitalization
Gestational age <28 week or >34 week
Metabolic disorder
Respiratory difficulties caused by nervous system disease or muscle disease
cyanotic heart disease
Birth at out of hospital studied
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Age
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From 1 day old to 1 day old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
148
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study ,individuals are randomly divided into two groups of nasal continuous positive air way pressure and duo positive air way pressure based on random quadratic randomization method which is cited by the http://www.sealedenvelope.com/simple-randomiser/v1/lists site.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study patient who are actually neonate,after obtaining consent from the parents ,randomly enter the study .And the implementation of the study is the responsibility of the therapist ,and the neonate does not interfere with the setting of the device.Also Researcher and data analyst do not interfere with the implementation of the study .
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-08-04, 1397/05/13
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Ethics committee reference number
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IR.AJUMS.REC.1397.365
Health conditions studied
1
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Description of health condition studied
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Respiratory distress syndrom
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ICD-10 code
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P22.0
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ICD-10 code description
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Respiratory distress syndrome of newborn
Primary outcomes
1
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Description
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Non invasive ventilation failure that require intubation and mechanical ventilation during 72 hours after entrance to study
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Timepoint
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During the first 72 hours of admission to study
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Method of measurement
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The failure of treatment is considered to be when there are one or two of the following conditions.first condition included partial pressure of carbon dioxide in arterial blood >60 millimeter of mercury and potential hydrogen of arterial blood<7/2 and partial pressure of oxygen in arterial blood <50 millimeter of mercury with fraction of inspired oxygen >60% and positive end expiratory pressure >8 centimeters of water in method of nasal continuous positive air way pressure and duo pressure >15 centimeters of water and positive end expiratory pressure >8 centimeters of water and fraction of oxygen of >60% in method of nasal duo positive air way pressure .second condition included worsening of clinical conditions (increased respiratory distress by tachypnea and severe retraction of chest )or prolong apnea (apnea for more than 20 seconds )or repeated apnea for more than 2 time in 24 hours with cyanosis and bradycardi <100 beat in minute that require ventilation with bag and mask.
Secondary outcomes
1
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Description
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Intra ventricular hemorrhage
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Timepoint
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brain ultrasound performed by the radiologist on days 1 and 3 and 7 and 14 and 28 after admission
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Method of measurement
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By ultrasound of the brain performed by the radiologist
2
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Description
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Patent ductus arteriosus (A duct that establishes the connection between the pulmonary artery and the aorta that after birth,it is naturally closed and failure in this will result in patent ductus arteriosus).
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Timepoint
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During the first 48 hours of birth or presence of clinical symptoms of patent ductus arteriosus like hearing asystolic murmur or hypotension
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Method of measurement
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Echocardiography is done by the pediatric cardiologist
3
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Description
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Chronic lung disease(oxygen dependence at gestational age 36 weeks)
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Timepoint
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Up to 36 weeks gestational age
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Method of measurement
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Assessment of oxygen dependence by pulse oximetry
4
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Description
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Air leak syndroms (alveolar rupture due to severe dilation and air entrances to the pleural space)
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Timepoint
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The length of time the patient is treated with one of two methods of nasal continuous positive air way pressure or nasal Duo positive air way pressure .
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Method of measurement
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chest x ray
5
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Description
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Duration of hospitalization
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Timepoint
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From hospitalization until discharge
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Method of measurement
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Based on patient records
6
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Description
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The occurrence of death
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Timepoint
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During treatment with either of the two methods studied
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Method of measurement
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Clinical evaluation of the absence of vital signs
7
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Description
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Apnea (Respiratory interruption that last more than 20 seconds or less than 20 seconds but with cyanosis and bradycardia less than 100 beats per minute).
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Timepoint
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During treatment with either of the two methods studied
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Method of measurement
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Pulse oximetry
8
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Description
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The number of surfactants used(A type of lipoprotein that is present in the inner wall of the alveolus .this drug used for respiratory distress syndrome) .
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Timepoint
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First 48 hours after intervention
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Method of measurement
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Pulse oximetry and need to oxygen fraction>40% and positive end expiratory pressure >= 4-6 and measurement of arterial blood gases
Intervention groups
1
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Description
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Intervention group:The first group is neonates who are under nasal continuous positive air way pressure. fabian device from switzerland country , is used to apply this method.
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Category
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Treatment - Devices
2
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Description
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Intervention group: In second group ,neonate are under nasal duo positive air way pressure .Fabian device from switzerland country,is used to apply this method.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Considering that this study will be carried out for the first time in Iran,and only at the Imam Khomeini Hospital of Ahwaz and not multi center ,we do not decide to publish individual participants data ,but the results are certainly presented as an article.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available