Protocol summary

Summary
In this study we will compare NCPAP (Nasal Continuous Positive Airway Pressure) with HFNC (High Flow Nasal Cannula) in newborn infants with respiratory distress syndrome (RDS) who will place on one of this method after receiving surfactant and extubation. This will be a prospective Balanced Block Randomization study among 54, 28-34 weeks, newborns with respiratory distress syndrome who are admitted to the NICUs’ at Arash Hospital and Children’s Medical Center. Patients will be excluded with major congenital anomalies, congenital heart diseases, and Apgar score less than 5 in 5 minutes. To avoid misdistribution of gestational age and sex, the patients will systematically be blocked on gestational age and sex using four categories; 28-30 wk males, 28-30wk females, 31-34wk males, 31-34wk females. After ethical approval and explanation for parents and obtaining written informed consent, neonates with indication of exogenous surfactant administration will be intubated, surfactant will be administrated and then they will be extubated within a few hours by physician judgment. After extubation one group of patients will receive NCPAP, and another group will receive HFNC. These patients will be followed closely and monitored for hypercarbia (Pco2≥60) with a pH of <7.25, hypoxemia Pao2<50 with FIO2>0.7, for reintubation. The primary outcome is remaining extubatation for at least 3 days and secondary outcomes is duration of oxygen therapy and hospitalization, and survival. Two groups will finally be compared with each other by student’s t-test for continuous data and x2 test and fisher’s exact test for categorical data.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201228800N1
Registration date: 2012-08-11, 1391/05/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-11, 1391/05/21
Registrant information
Name
Maliheh Kadivar
Name of organization / entity
Children's Medical Center, Terhan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 7648
Email address
kadivarm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Maternal, Fetal & Neonatal Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing High flow nasal cannula versus nasal CPAP for INSURE treatment of neonatal respiratory distress syndrome
Public title
Comparing two types of noninvasive mechanical ventilation in neonatal respiratory distress after surfactant replacement therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: preterm infants with respiratory distress; need for surfactant therapy; gestational age 28-34 wks; parental written consent. Exclusion criteria: babies with major congenital anomalies; congenital heart disease; asphyxia with apgar score less than 5 in 5 minutes.
Age
To 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
history of corticosteroid prophylaxis in perinatal period and GA assessment

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe of Tehran University of Medical Sciences
Street address
#16 Azar St, Ethics Research Center
City
Tehran
Postal code
Approval date
2012-07-10, 1391/04/20
Ethics committee reference number
16342

Health conditions studied

1

Description of health condition studied
INSURE in Neonatal Respiratory Distress Syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Reintubation
Timepoint
after intervention till 3 days
Method of measurement
ABG assessment and RDS score and FIO2 requirment

Secondary outcomes

1

Description
duration of oxygen therapy
Timepoint
after intervention till discharge
Method of measurement
day

2

Description
amount of oxygen therapy
Timepoint
after intervention
Method of measurement
fraction of oxygen

3

Description
survival
Timepoint
after intervention till discharge
Method of measurement
alive or death

Intervention groups

1

Description
control group: intubation, surfactant replacemnt therapy, extubation to NCPAP
Category
Other

2

Description
Case group: intubation, surfactant replacemnt therapy, extubation to HFNC
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Subspeciality Center
Full name of responsible person
Shahin Nariman- Maliheh Kadivar
Street address
#162 Martyr Abdlohamid Alley, Baghdarnia St, Resalat Ave
City
Tehran

2

Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Maliheh Kadivar- Razieh Sangsari
Street address
No. 62, Gharib St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Maternal, Fetal & Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Nayeri MD
Street address
Valiasar Hospital, Imam Khomeini Complex Center, Keshavarz Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maternal, Fetal & Neonatal Research Center, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahin Nariman MD
Position
Neonatologist, Chief of Neonatal Intensive Care Unit of Arash Hospital
Other areas of specialty/work
Street address
#162 Martyr Abdlohamid Alley, Baghdarnia St., Resalat Ave
City
Tehran
Postal code
Phone
+98 21 7788 3284
Fax
+98 21 7788 3196
Email
shaahin_nariman@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Children's Medical Center, Tehran University of Medical Sciences
Full name of responsible person
Maliheh Kadivar MD
Position
Neonatologist; Chief of Neonatal Intensive Care Unit of Children's Medical Center
Other areas of specialty/work
Street address
# 62 Gharib St, Keshavarz Ave
City
Tehran
Postal code
Phone
+98 21 6691 7648
Fax
+98 21 6692 9235
Email
kadivarm@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Maliheh Kadivar MD
Position
Chief of NICU Children's Medical Center
Other areas of specialty/work
Street address
# 62 Gharib St, Keshavarz Ave.
City
Tehran
Postal code
Phone
+98 21 6692 0981
Fax
Email
kadivarm@sina.tums.ac.ir
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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