This study is conducted to compare the efficacy of high flow nasal cannula and continuous positive airway pressure in surfactant replacement therapy for respiratory distress syndrome. In a randomized clinical trial, 80 preterm infants with gestation age 30-35 weeks and respiratory distress syndrome who admit in NICU for surfactant replacement therapy would be categorized in two groups according to random number list. Infants will be intubate by appropriate size endo- tracheal tube and receive intra tracheal surfactant after confirmation correct position of tracheal tube. Then, infants extubate and randomly allocated in two groups. Patients in group A will receive humidified warm oxygen by high flow nasal cannula and patients in group B support by nasal continuous positive airway pressure. All patients follow and compare for need for re-intubation in next 72 hours after INSURE, pulmonary complications including pneumothorax, chronic lung disease, extra pulmonary complications including retinopathy of prematurity, intra-ventricular hemorrhage, nasal injury and duration of hospitalization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308283915N9
Registration date:2013-09-18, 1392/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-18, 1392/06/27
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2013-07-08, 1392/04/17
Expected recruitment end date
2014-03-08, 1392/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of HHFNC Versus NCPAP after Surfactant therapy with INSURE method in preterm infants with respiratory distress syndrome
Public title
comparing two method of respiratory support after surfactant administration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: preterm infants with gestation age 30-35 weeks; admission in NICU with respiratory distress; treatment with surfactant
Exclusion criteria: preterm infants with gestation age less than 30 week or above 35 week; intubation immediately after birth before surfactant therapy; respiratory distress score more than 8; severe respiratory distress syndrome in chest x ray.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethic Committee of Research Vice Chancellor of Tabriz University of Medical Sciences
Street address
Gholghasht street
City
Tabriz
Postal code
Approval date
2013-07-07, 1392/04/16
Ethics committee reference number
5/4/3170
Health conditions studied
1
Description of health condition studied
respiratory distress syndrome
ICD-10 code
p22
ICD-10 code description
Respiratory distress of newborn
Primary outcomes
1
Description
need for intubation in first 72 hours
Timepoint
every hour till 2 hours
Method of measurement
clinical assessment
Secondary outcomes
1
Description
bronchopulmonary dysplasia
Timepoint
daily till 28 days
Method of measurement
clinically by supplementary oxygen reception
2
Description
duration of hospitalization
Timepoint
daily till discharge
Method of measurement
medical records
Intervention groups
1
Description
Respiratory support by using continuous positive airway pressure ( with positive end expiratory pressure4-6 cm H2o)) started immediately after surfactant replacement therapy in group B
Category
Treatment - Devices
2
Description
Respiratory support with humidified high flow nasal cannula (2-6 lit/min) started immediately after surfactant replacement therapy in group A
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Manizheh Mostafa Gharehbaghi
Street address
south Artesh street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Gholghasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Mostafa Gharehbaghi
Position
Associate Professor of pediatrics
Other areas of specialty/work
Street address
Alzahra Hospital; South Artesh street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
gharehbaghimm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Mostafa Gharehbaghi
Position
Associate professor of pediatrics
Other areas of specialty/work
Street address
Alzahra Hospital, south Artesh street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
gharehbaghimm@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)