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Protocol summary

Study aim
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
Design
Randomized clinical trial study with parallel groups and blinded ,with sample size of 148 patients
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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
Main outcome variables
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

Reason for update
Acronym
IRCT registration information
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
Registration date
2018-09-10, 1397/06/19
Registrant information
Name
Mina Agahin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2043
Email address
agahin.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
."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"
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 148
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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 .
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences,Esfand avenue,Golestan Bulvar
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.AJUMS.REC.1397.365

Health conditions studied

1

Description of health condition studied
Respiratory distress syndrom
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Non invasive ventilation failure that require intubation and mechanical ventilation during 72 hours after entrance to study
Timepoint
During the first 72 hours of admission to study
Method of measurement
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

Description
Intra ventricular hemorrhage
Timepoint
brain ultrasound performed by the radiologist on days 1 and 3 and 7 and 14 and 28 after admission
Method of measurement
By ultrasound of the brain performed by the radiologist

2

Description
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).
Timepoint
During the first 48 hours of birth or presence of clinical symptoms of patent ductus arteriosus like hearing asystolic murmur or hypotension
Method of measurement
Echocardiography is done by the pediatric cardiologist

3

Description
Chronic lung disease(oxygen dependence at gestational age 36 weeks)
Timepoint
Up to 36 weeks gestational age
Method of measurement
Assessment of oxygen dependence by pulse oximetry

4

Description
Air leak syndroms (alveolar rupture due to severe dilation and air entrances to the pleural space)
Timepoint
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 .
Method of measurement
chest x ray

5

Description
Duration of hospitalization
Timepoint
From hospitalization until discharge
Method of measurement
Based on patient records

6

Description
The occurrence of death
Timepoint
During treatment with either of the two methods studied
Method of measurement
Clinical evaluation of the absence of vital signs

7

Description
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).
Timepoint
During treatment with either of the two methods studied
Method of measurement
Pulse oximetry

8

Description
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) .
Timepoint
First 48 hours after intervention
Method of measurement
Pulse oximetry and need to oxygen fraction>40% and positive end expiratory pressure >= 4-6 and measurement of arterial blood gases

Intervention groups

1

Description
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.
Category
Treatment - Devices

2

Description
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.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit of Ahvaz Imam Khomeini Hospital
Full name of responsible person
Mina Agahin
Street address
Imam Khomeini Hospital,Azadegan avenue,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2043
Fax
Email
agahin.m@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahwaz University of Medical Sciences,Esfand avenue,Golestan bulvar
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3373 8383
Email
badavi_m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Agahin
Position
Fellowship in neonatal medicine
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.37,East Pahlevan Avenue ,Kian pars Town
City
Ahwaz
Province
Khouzestan
Postal code
6155683567
Phone
+98 61 3222 2043
Email
agahin.m@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Agahin
Position
Fellowship in neonatal medicine
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No 37, East pahlevan avenue, Kian Pars Town
City
Ahwaz
Province
Khouzestan
Postal code
6155683567
Phone
+98 61 3222 2043
Email
agahin.m@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Agahin
Position
Fellowship In Neonatal Sience
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No 37,East Pahlevan Avenue,Kian Pars Town
City
Ahwaz
Province
Khouzestan
Postal code
6155683567
Phone
+98 61 3222 2043
Email
agahin.m@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
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.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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