Comparing the efficacy of surfactant administration by laryngeal mask airway (LMA) and endotracheal intubation in neonatal respiratory distress syndrome
In a randomized clinical trial 70 preterm neonates with gestation age 33-37 weeks that diagnosed as respiratory distress syndrome and need treatment with surfactant will randomly allocate to two groups. Thirty five neonates receive surfactant via endotracheal tube and 35 with laryngeal mask. Then patients will be extubated. Premedication and management with fentanyl is same in both groups. We follow patients with respect to need for FiO2 to maintain normal O2 saturation and need for intubation and assisted ventilation during the first 3 days after surfactant therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411183915N12
Registration date:2014-11-28, 1393/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-28, 1393/09/07
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
Tabriz University of Medical Sciences
Expected recruitment start date
2014-11-21, 1393/08/30
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of surfactant administration by laryngeal mask airway (LMA) and endotracheal intubation in neonatal respiratory distress syndrome
Public title
Comparing the efficacy of surfactant administration by laryngeal mask airway (LMA) and endotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gestation age 33-37 weeks; confirmed diagnosis of respiratory distress syndrome according to clinical and radiological findings; treatment with surfactant
Exclusion criteria: major congenital anomalies; congenital heart disease; cranio-facial anomalies; esophageal atresia; birth weight less than 1800 grams
Age
From 1 day old to 3 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences
Street address
Golghasht street
City
Tabriz
Postal code
Approval date
2014-11-10, 1393/08/19
Ethics committee reference number
93116
Health conditions studied
1
Description of health condition studied
Respiratory Distress Syndrome
ICD-10 code
p22
ICD-10 code description
Respiratory distress syndrome
Primary outcomes
1
Description
Reduced needed FiO2 to maintain adequate oxygenation
Timepoint
Before and one hour after surfactant therapy
Method of measurement
Determination of needed Fio2 in blender and by pulse oxymetry
Secondary outcomes
1
Description
Need for intubation and assisted ventilation
Timepoint
Till 3 days after treatment
Method of measurement
Pulse oxymetry and blood gas analysis
Intervention groups
1
Description
Intervention group: administration of surfactant 4cc/kg survanta in 4 divided dose via laryngeal mask after receiving 1-2 µ/kg intravenous fentanyl
Category
Treatment - Drugs
2
Description
Control group: administration of surfactant 4cc/kg survanta in 4 divided dose via endotracheal tube after receiving 1-2 µ/kg intravenous fentanyl
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Dr Reza Radfar
Street address
South Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor for Tabriz University of Medical Sciences
Full name of responsible person
Dr Farhoodi
Street address
Golgasht 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 for 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
Al Zahra Hospital
Full name of responsible person
Dr Reza Radfar
Position
Fellowship of Neonatology
Other areas of specialty/work
Street address
South Artesh street
City
Tabriz
Postal code
Phone
+98 41 3553 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
Dr Manizheh Mostafa Gharehbaghi
Position
Professor
Other areas of specialty/work
Street address
South Artesh street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
gharehbaghimm@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)