The Effect of Oral Propranolol Treatment on Preterm Retinopathy
Design
A clinical trial with a control and case group, single-blind, randomized
Settings and conduct
This study was performed at the NICU of Shahid Sadoughi hospital in Yazd.the case group received 0.5 mg/kg/dose oral of propranolol every 12 hours. The retinopathy process in neonates of both groups was monitored every week until the final status of ROP was determined by retinal fixation without knowledge of the neonates of each group .
Participants/Inclusion and exclusion criteria
The study included preterm infants who had been admitted to NICU.twenty-seven newborns were included based on the following criteria: infants born with > 26 weeks’ gestation ; birth weight < 1500 g; and retinopathy Grade I and II.The exclusion criteria were that the gestational age of< 26 weeks, Intra-ventricular hemorrhage (IVH) Grade II and III, neonates with congenital anomalies, Heart disease except Patent Ductus Arteriosus (PAD) , congenital infectious (TORCH) and acute sepsis.
Intervention groups
infants were randomly assigned to two group.the control group, does not receive any drug.In the case group, the initial dose of oral propranolol was 0.25 mg/kg/dose for 2 days. Then received to 0.5 mg/kg body weight/dose every 12 h.
Main outcome variables
Improvement in retinopathy, need for laser therapy, the need for injection of Bevacizumab, Complications of propranolol in the intervention group, hemodynamic variables before and 24 hours after the start of treatment in the case group, duration of drug in the intervention group according to the response to treatment
General information
Reason for update
Acronym
ROP
IRCT registration information
IRCT registration number:IRCT20100520003982N1
Registration date:2019-01-23, 1397/11/03
Registration timing:retrospective
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
09131584474
Email address
dr.akrammirjalili@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-07, 1396/04/16
Expected recruitment end date
2018-07-07, 1397/04/16
Actual recruitment start date
2017-07-07, 1396/04/16
Actual recruitment end date
2018-11-04, 1397/08/13
Trial completion date
2018-12-21, 1397/09/30
Scientific title
Effect of oral propranolol in retinopathy of prematurity
Public title
Effect of propranolol in retinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm infants less than 1500 gr
Preterm infants with gestational age greater than 26 weeks and less than 32 weeks
Preterm infants with retinopathy grade I and II ROP
Preterm infants admitted to NICU.
Exclusion criteria:
Congenital malformation
cardiovascular problems except Patent Ductus Arteriosus (PAD)
active sepsis
Congenital infections (TORCH)
Intraventricular hemorrhage (IVH) Grade II and III
Age
From 182 days old to 224 days old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
27
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using a random number table . To use the random numbers table, we considered the table numbers from the left to read the table numbers. Then, by placing a number and moving in the left direction, the odd numbers for control and the pair numbers were considered for intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The doctor examines newborns without knowing the grouping of them .
Also, the Data analyzer did not know the groups and identified them as groups A and B.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Alam Square,Safayeh
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-07-07, 1396/04/16
Ethics committee reference number
IR-MEDICIN.REG.1396.48
Health conditions studied
1
Description of health condition studied
Retinopathy of prematurity
ICD-10 code
H35.1
ICD-10 code description
Retinopathy of prematurity
Primary outcomes
1
Description
Retinopathy process
Timepoint
On the 28th day after birth (before entering the study), every week until the end of study
Method of measurement
Indirect ophthalmoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral propranolol (prilol 10 from OLIDARU): Start with dose of 0.25 mg / kg / dday for two days , then take 0.5mg / kg / day every 12 hours until the patient needs laser therapy or intra-ocular injection, or healing is complete without an aggressive treatment.
Category
Treatment - Drugs
2
Description
Control group: does not receive any drugs. Ophthalmic examinations (indirect ophthalmoscopy) were performed on a weekly basis from day 28 of birth for all infants admitted to the neonatal intensive care unit.In the absence of improvement in the baby, aggressive therapies including laser therapy and Bevacizumab injections were performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Neonatal Intensive Care Unit - Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Dr. Mahmood Noori Shadkam
Street address
Shahid Sadughi Huspital, Sina rd, Shahid Ghandi Buval
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 8224 0009
Email
medschool@ssu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Akrm Mirjalili
Street address
Paknezhad Bulvar
City
Yazd
Province
Yazd
Postal code
8916976745
Phone
+98 35 3726 4881
Email
dr.akrammirjalili@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?