Effect of intratracheal budesonide with surfactant in management of respiratory distress syndrome for prevention of bronchopulmonary dysplasia in preterm infants
Determination of efficacy of budesonide with surfactant administration in respiratory distress syndrome for prevention of bronchopulmonary dysplasia
Design
preterm infants that met inclusion criteria, randomly allocated in two groups.In control group, neonates receive initial dose of curosurf 2.5cc/kg intratracheally. Patients in intervention group receive budesonide 0.25 mg/kg in addition to intratracheal curosurf with same initial dose . We follow all neonates till discharge with respect to need for second doses of surfactant at first 3 days of life, reintubation in first 3 days after extubation and duration of supplemental oxygen therapy .
Settings and conduct
Preterm newborn infants who have respiratory distress syndrome will randomly allocate in control group (surfactant) or intervention group (surfactant plus budesonide) by random numbers generated by computerized random number generator in closed envelops. Physician administer the drug in prepared syringes. A nurse who record the patients data will be blind to infant's group. Managing physician is blind about patients groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: preterm infants with gestation age 26-30 weeks and birth weight less than 1250 that have RDS and need to treat with surfactant
Exclusion criteria: birth asphyxia, severe congenital anomalies, shock and cardiovascular instability
Intervention groups
In control group, patients receive intratracheal surfactant (Curosurf) with initial dose of 2.5 cc/kg;
In intervention group, patients receive budesonide 0.25 mg/kg in addition to surfactant (Curosurf)
Main outcome variables
need to second doses of surfactant at first 3 days of life , need to reintubation in first 3 days after extubation , bronchopulmonary dysplasia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100512003915N20
Registration date:2018-07-07, 1397/04/16
Registration timing:registered_while_recruiting
Last update:2018-07-07, 1397/04/16
Update count:0
Registration date
2018-07-07, 1397/04/16
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
Expected recruitment start date
2018-04-16, 1397/01/27
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intratracheal budesonide with surfactant in management of respiratory distress syndrome for prevention of bronchopulmonary dysplasia in preterm infants
Public title
Administration of budesonide with surfactant and prevention of bronchopulmonary dysplasia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
gestation age 26-30 weeks
birth weight less than 1250 grams
respiratory distress syndrome
Exclusion criteria:
5 minute Apgar score less than 4
congenital heart disease except patent ductus arteriosus and atrial septal defect
necrotizing entrocololitis
major congenital anomalies, esophageal atresia, diaphragmatic hernia
chromosomal anomalies
shock
Age
From 1 day old to 3 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
newborn infants who met study criteria randomly allocate in two groups (surfactant and surfactant with budesonide) based on generated random number list
Blinding (investigator's opinion)
Double blinded
Blinding description
infants don't know the used drugs. clinical manager administer prepared drug according patients code. outcome is recorded by a nurse who is not aware administered drugs . researcher is blind about patients groups and records data
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. Gholgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
513866449
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR. TBZMED.REC.1397.041
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Reintubation in first 3 days after extubation
Timepoint
We evaluate the neonate immediately after intervention and daily till 3 days after intervention and extubation
Method of measurement
tracheal reintubation
2
Description
need to second doses of surfactant
Timepoint
Daily till day 3 of birth and 3 days after intervention
Method of measurement
surfactant administration
3
Description
Bronchopulmonary dysplasia
Timepoint
Daily till 28 days after birth and day 28 after intervention
Method of measurement
need to supplemental oxygen
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: neonates receive budesonide 0.25 mg/kg in addition to intratracheal surfactant