comparing the efficacy of two surfactant (alveofact, crusorf) in complications and duration of mechanical ventilation for management of respiratory distress syndrome in preterm infants
Objectives: to compare the efficacy of two different surfactant in the treatment of respiratory distress syndrome.
Design: randomized controlled clinical trial.
Setting and conduct: Preterm neonates that admitted in NICU of AL Zahra or Children hospital with respiratory distress syndrome who need surfactant replacement therapy will enrolled in this study .
Participants: Eighty pre term infants with gestation age less than 32 weeks and birth weight less than 1500 gram randomly allocated in two groups.
Forty preterm neonates will receive alveofact 1.2 ml/kg and 40 neonates receive crusorf 2.5 ml/kg intratrachealy.Infants with major congenital anomalies and and severe birth asphyxia will exclude from study.
Main outcome is the need for assisted ventilation for 7 days. Secondary outcomes are mortality before discharge due to prematurity, complications of RDS including pulmonary hemorrhage, bronchopulmonary dysplasia, PDA, air leak syndromes, retinopathy of prematurity, intra ventricular hemorrhage and sepsis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212123915N8
Registration date:2013-01-09, 1391/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-09, 1391/10/20
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
2012-09-30, 1391/07/09
Expected recruitment end date
2013-10-01, 1392/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the efficacy of two surfactant (alveofact, crusorf) in complications and duration of mechanical ventilation for management of respiratory distress syndrome in preterm infants
Public title
comparing two surfactant in management of respiratory distress syndrome in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: gestation age less than 32 weeks; birth weight less than 1500 gr
exclusion criteria:congenital malformations; severe birth asphyxia
Age
To 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tabriz university of medical sciences, Golgasht street, Tabriz
City
Tabriz
Postal code
Approval date
2012-10-15, 1391/07/24
Ethics committee reference number
91137
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
mechanical ventilation
Timepoint
daily for 7 days
Method of measurement
need for intubation and mechanical ventilation
Secondary outcomes
1
Description
mortality
Timepoint
daily tilldischarge
Method of measurement
death
2
Description
complications
Timepoint
till discharge
Method of measurement
presence of pulmonary hemorrhage, bronchopulmonary dysplasia, air leak syndrome, retinopathy of prematurity, sepsis
Intervention groups
1
Description
intratracheal alveofact 1.2 ml/ kg after diagnosis of RDS and repeat if needed every 12 hours till 3 doses
Category
Treatment - Drugs
2
Description
intratracheal crusorf 2.5 ml/kg at first dose and 1.25 ml/kg if repeated dose needed every 12 hours till 3 doses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Manizheh Mostafa Gharehbaghi
Street address
South Artesh street, Al Zahra hospital
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
Golgasht street, Tabriz University of Medical Sciences
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
asocciate professor
Other areas of specialty/work
Street address
Al Zahra 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
Al Zahra 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)