The purpose of this study is comparing the side effects of respiratory distress syndrome between premature neonates having birth weight of less than 1500 gram taking prophylactic surfactant in the first 6 hours after birth and those who do not take the surfactant. Also we want to compare the decrease rate of side effects in the routine prophylactic method (BW<1250 gram in the first 2 hours of birth) and the recommended one (BW<1500 gram in the first 6 hours of birth) to reach the appropriate time and weight for prophylactic treatment. Our study is a non-blinded randomized clinical trial which its entrance criteria is a neonate suffering from respiratory distress syndrome (hyaline membrane disease) with body weight of less than 1500 gram and its exit criteria are body weight of more than 1500 gram or intrauterine growth retardation. This research has been performed on 182 neonates <1500 gram during 1 year, that 90 cases were in the intervention group (taking surfactant) and 92 ones were in the control group ( not taking any surfactant ). In this study, the surfactant solution was survanta, ordered through the dose of 2 ml/kg as soon as possible (before passing the first 6 hours of birth) via tracheal tube, as many as it was required. At the end the, main outcome (death) and the other outcomes including pulmonary hemorrhage, pneumothorax, intracranial hemorrhage and PDA were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905104486N1
Registration date:2010-09-25, 1389/07/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-25, 1389/07/03
Registrant information
Name
Jabarali Safaei
Name of organization / entity
Kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
00988314276310, 00988314276311(2245)
Email address
dr.jsafaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic surfactant in first 6 hour of life on outcome of premature neonate less than1500 gram
Public title
Effect of prophylactic surfactant on outcome of premature neonate
Purpose
Treatment
Inclusion/Exclusion criteria
INCLUSION CRITERIA: gestational age < 34 weeks, birth weight <1500 gram , respiratory distress syndrome (hyaline membrane disease). EXCLUSION CRITERIA: gestational age > 34 weeks, birth weight >1500 gram, intrauterine growth retardation, other respiratory disease without RDS.
Age
To 21 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
182
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
Kermanshah University of Medical Sciences
Street address
No. 2, Sepah square
City
Kermanshah
Postal code
Approval date
2010-05-17, 1389/02/27
Ethics committee reference number
420/9234 /7/پ
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrom of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
death
Timepoint
during the study
Method of measurement
physical exam
Secondary outcomes
1
Description
pulmonary hemorrhage
Timepoint
while studying
Method of measurement
physical exam & chest-x-ray
2
Description
pneumothorax
Timepoint
while studying
Method of measurement
physical exam & chest-x-ray
3
Description
intraventricular hemorrhage (IVH)
Timepoint
while studying
Method of measurement
physical exam & cranial sonography
4
Description
patent ductus arteriosus (PDA)
Timepoint
while studying
Method of measurement
physical exam & echocardiography
Intervention groups
1
Description
Surfactant solution (survanta), 2 ml per KG of body weight, as soon as possible (before passing the first 6 hr of birth), via tracheal tube, as many as it was required
Category
Treatment - Drugs
2
Description
no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Jabarali Safaei
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
No. 2, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?