Comparing of short term outcome of treatment with two porcine and bovine natural surfactant in neonatal respiratory distress, a randomized clinical trial study
The aim of present study was to compare of short term outcome of treatment with two porcine and bovine surfactant in neonatal respiratory distress. In a double blind single center clinical trial study, 100 premature neonates who referred to Alzahra Hospital of Tabriz University of Medical Sciences and needs surfactant treatment will select randomly and with using random numbers table will allocate in two groups of intervention and control group. Inclusion criteria are, premature neonates, birth weight less than or equal 1250 grams, respiratory distress, and indication for surfactant. Exclusion criteria are congenital heart disease, and fifth minute Apgar score less than five. In intervention group neonates will receive 2.5 cc per kg porcine surfactant endotracheal within two hours of birth and in control group neonates receive 5 cc per kg bovine surfactant endotracheal within two hours of birth. Patients will follow up for 2 weeks. Lipid profile level will measure at beginning of study, first month, third month, and also at the end of 6th month. Improvement of neonatal respiratory distress is as primary variable of study and side effect is as secondary variable of present study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092119250N1
Registration date:2016-08-24, 1395/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
Majid Mahallei
Name of organization / entity
Department of Pediatrics, Tabriz University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 1949
Email address
m.mahallei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of short term outcome of treatment with two porcine and bovine natural surfactant in neonatal respiratory distress, a randomized clinical trial study
Public title
Comparing of short term outcome of treatment with two porcine and bovine surfactant in neonatal respiratory distress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: premature neonates; birth weight less than or equal 1250 grams; respiratory distress; indication for surfactant. Exclusion criteria: congenital heart disease; fifth minute Apgar score less than five.
Age
To 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences.
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Postal code
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
TBZMED.REC.1394.1198
Health conditions studied
1
Description of health condition studied
Respiratory distress
ICD-10 code
P22.8
ICD-10 code description
Other respiratory distress of newborn
Primary outcomes
1
Description
Improvement of Respiratory distress
Timepoint
During admission
Method of measurement
Physical examination
Secondary outcomes
1
Description
Adverse effects
Timepoint
2 weeks later
Method of measurement
Patient follow up
Intervention groups
1
Description
In intervention group: neonates will receive 2.5 cc per kg porcine surfactant endotracheal within two hours of birth.
Category
Treatment - Drugs
2
Description
In control group: neonates will receive 5 cc per kg bovine surfactant endotracheal within two hours of birth.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Dr Majid Mahallei
Street address
Alzahra Hospital of Tabriz University of Medical Sciences, Artesh Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Dr Majid Mahallei
Position
Subspecialty of Neonates.
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3385 1949
Fax
Email
medicalresearchtbz@gmail.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 Majid Mahallei
Position
Subspecialty of Neonates
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3385 1949
Fax
Email
medicalresearchtbz@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Majid Mahallei
Position
Subspecialty of Neonates
Other areas of specialty/work
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3385 1949
Fax
Email
medicalresearchtbz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)