Protocol summary

Summary
Premature infants with respiratory distress syndrome (RDS) usually require respiratory support. Due to the complications of intubation and mechanical ventilation, in the last decade, attempts have been made to use non-invasive methods in management of these patients. One of the most commonly used non-invasive methods is nasal CPAP. However, some neonate with this therapeutic approach also developed respiratory failure and they need more respiratory support. So far, the beneficial effects of high frequency ventilators have been shown in management of RDS, However, its effect on the nasal method has been less studied. In this study we evaluate the efficacy of nasal high frequency ventilation (NHFV) in reducing the duration of respiratory distress compared with nasal continuous positive airway pressure (NCPAP) in RDS. In this randomized-prospective study, 62 infants with a gestational age ≥ 30 weeks and birth weight ≥ 1000 g with RDS and spontaneous breathing since birth will randomized to either NHFV (n = 31) or NCPAP (n = 31). Infant were excluded if there was any of the following cases: major congenital anomalies; asphyxia and cyanotic congenital heart disease. The primary outcome is the reduction of the duration of respiratory distress. Secondary outcome are the duration and level of oxygen supplementation, the incidence of complications such as pneumothorax, necrotizing enter colitis, sepsis and respiratory failure requiring intubation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017062734782N1
Registration date: 2017-09-09, 1396/06/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-09, 1396/06/18
Registrant information
Name
Ramin Iranpour
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3386 8247
Email address
iranpour@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Isfahan, Iran
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of Nasal high frequency ventilation(NHFV) versus nasal continuous positive airway pressure(NCPAP) for respiratory distress syndrome in newborn with birth with more than 1000 gram and more than 30 week of gestational age
Public title
The efficacy of nasal high frequency ventilation in treatment of neonatal respiratory syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: premature and term neonate; more than 1000 gram and 30 weeks of gestational age; spontaneous breathing; respiratory distress syndrome symptoms required treatment Exclusion criteria: major congenital anomaly; diaphragmatic hernia; cyanotic heart disease; intrauterine growth retardation; asphyxia
Age
To 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar-Jerib St.,Isfahan University of Medical Sciences
City
Isfahan
Postal code
8184757851
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.MUI.REC.1396.3.336

Health conditions studied

1

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

Primary outcomes

1

Description
The duration of non-invasive support
Timepoint
Every hour
Method of measurement
hourly NICU recorded sheets

Secondary outcomes

1

Description
pulmonary hemorrhage
Timepoint
hourly
Method of measurement
physical exam and chest xray if needed

2

Description
narcotizing enterocolitis (NEC)
Timepoint
Daily
Method of measurement
Daily recorded sheets and daily physical exam and abdominal xray if needed

3

Description
Intraventricular hemorrhage (IVH)
Timepoint
at the 3rd and 7th days after birth
Method of measurement
brain sonography

4

Description
respiratory failure and intubation
Timepoint
continuously every hour during non-invasive respiratory support
Method of measurement
NICU record sheets

5

Description
pnuemothorax
Timepoint
continuously every hour during non-invasive respiratory support
Method of measurement
NICU record sheets

6

Description
chronic lung disease
Timepoint
4 weeks after birth
Method of measurement
NICU record sheets

7

Description
patent ductus arteriosus
Timepoint
Daily physical exam
Method of measurement
Daily recorded sheets

8

Description
time to full enteral feeding
Timepoint
Daily till full feeding
Method of measurement
Daily recorded sheets

Intervention groups

1

Description
Infants with respiratory distress syndrome according of inclusion criteria randomized to NCPAP (control group) will treat with nasal CPAP shortly after birth. CPAP pressure will consider as 6-7 cmH20 and FIO2 adjust to maintain o2 saturation of patients between 89-95%. Surfactant (200mg/kg first dose and then 100mg/kg the next doses, curosurf (Chiesa pharmaceuticals, Parma, Italy) will administrate if patients need FIo2 > 35% to keep desired SPO2. If FIO2 reach to under 30% patient wean to Humidified High Flow Nasal Cannula (HHFNC) and when FIO2 reach to 21% and respiratory distress improved, HHFNC also will discontinued. Surfactant administrate as INSURE method. NCPAP failure defined as apnea or PH<7.2 and Pco2 >60 mmHg.
Category
Treatment - Devices

2

Description
Infants with respiratory distress syndrome according of inclusion criteria randomized to NHFV (control group) will treat with nasal high frequency ventilator [Fabian, Acutronic Medical Systems AG, based in Hirzel (Zurich, Switzerland)], shortly after birth. Pmean pressure will consider as 8 cmH20 and FIO2 adjust to maintain O2 saturation of patients between 89-95%. Initial frequency will set as 10 Hz. Amplitude will set based the vibration of upper chest wall and the neck of patients and increased to maximum 20mmHg. Surfactant (200mg/kg first dose and then 100mg/kg the next doses, curosurf (Chiesa pharmaceuticals, Parma, Italy) will administrate if patients need FIo2 > 35% to keep desired SPO2. If FIO2 reach to under 30% patient wean to Humidified High Flow Nasal Cannula (HHFNC) and when FIO2 reach to 21% and respiratory distress improved, HHFNC also will discontinued. Surfactant administrate as INSURE method. NCPAP failure defined as apnea or PH<7.2 and Pco2 >60 mmHg.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Ramin Iranpour
Street address
sofeh bolvar
City
Isfahan

2

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Ramin Iranpour
Street address
Motahari street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
ِDr Bahram Nasr
Street address
Hezar-jerib street
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
Dr Ahmadreza Abedi
Position
fellowship of neonatology
Other areas of specialty/work
Street address
Isfahan medical faculty, Pediatric ward
City
Isfahan
Postal code
Phone
+98 31 3386 8247
Fax
Email
Aabedi58@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ramin Iranpour
Position
Neonatologist/Associate Professor
Other areas of specialty/work
Street address
Mardavij avenue, Resalat Jonobi, Number16
City
Isfahan
Postal code
8168967893
Phone
+98 31 3668 1555
Fax
Email
iranpour@med.mui.ac.irramin.iranpour@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ramin Iranpour
Position
Neonatologist/ Associate Professor
Other areas of specialty/work
Street address
Mardavij avenue,Resalat Jonobi,Number 16
City
Isfahan
Postal code
8168967893
Phone
+98 31 3668 1555
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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