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The effect of melatonin in the prevention of retinopathy of prematurity in preterm neonates

Protocol summary

Study aim
Determining the effect of melatonin on prevention of retinopathy of prematurity
Design
A clinical trial with parallel groups, double-blinded, randomized (permuted block randomization), phase 3 on 60 neonates with retinopathy of prematurity, using www.sealedenvelope.com for randomization.
Settings and conduct
This study is performed in Ali Asghar,Akbarabadi and Firoozabadi Hospital. neonates with retinopathy of prematurity are randomly assigned into two groups. In the intervention group, neonates take melatonin. In the control group, neonates get routine treatment. In this study, investigator and physician did not know the type of medication they received.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Parents satisfaction to participate in the study, Premature newborns under 34 weeks, Lack of congenital anomalies, Lack of genetic disorder, metabolic disorder or suffering from TORCH, Lack of intraventricular hemorrhage (grade 3 and 4). Exclusion criteria:ntraventricular hemorrhage (grade 3 and 4) during patients follow up, Incidence of gastrointestinal complications such as NEC during treatment if it is not possible to take the medicine orally, Taking less than 14 days of melatonin.
Intervention groups
In the Intervention group neonates receive melatonin softgel (Dana Company, Iran) daily at dosage of 3 mg/ kg/day until 37 weeks and in the control group neonatess gets only routine treatment.
Main outcome variables
Stopping abnormal development of retinal vessels and nerves

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211226053528N2
Registration date: 2022-09-21, 1401/06/30
Registration timing: retrospective

Last update: 2022-09-21, 1401/06/30
Update count: 0
Registration date
2022-09-21, 1401/06/30
Registrant information
Name
Nastaran Khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
khosravi.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin in the prevention of retinopathy of prematurity in preterm neonates
Public title
The effect of melatonin in the prevention of retinopathy of prematurity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parents satisfaction to participate in the study Premature newborns under 34 weeks Lack of congenital anomalies Lack of genetic disorder, metabolic disorder or suffering from TORCH Lack of intraventricular hemorrhage (grade 3 and 4)
Exclusion criteria:
Intraventricular hemorrhage (grade 3 and 4) during patients follow up Incidence of gastrointestinal complications such as NEC during treatment if it is not possible to take the medicine orally. Taking less than 14 days of melatonin
Age
From 1 day old to 7 days old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method is used and the block size is 6. The website https://www.sealedenvelope.com is used to generate random sequences. Each participant is assigned a sequence. Then, each participant was randomly assigned to one of the arms of the study (A or B). The random sequence is given to the epidemiologist of the study, and every patient who enters the study, the doctor will contact him to find out whether the person will enter group A or B.
Blinding (investigator's opinion)
Double blinded
Blinding description
After random allocation, the randomized list will be placed in sealed envelopes. In this way, the first doctor will be blinded to assigning people to treatment groups. Regarding to ophthalmologist does not know about the treatments provided, he will be blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway, Next to the Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IR.IUMS.FMD.REC.1400.542

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
Stopping of abnormal blood vessels formation in the retina
Timepoint
End of 37 weeks and end of 44 weeks
Method of measurement
Examination by retina fellowship and with ophthalmoscope

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Babies receive melatonin softgel (Nutralab under license of Canada) daily at dosage of 3 mg/ kg/day until 37 weeks.
Category
Treatment - Drugs

2

Description
Control group: This group of neonatess gets only routine treatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Hamid Khalilian
Street address
Molavi St, Molavi (cross)
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
hkhalilian1410@gmail.com

2

Recruitment center
Name of recruitment center
Aliasghar Children's Hospital
Full name of responsible person
Hamid Khalilian
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
hkhalilian1410@gmail.com

3

Recruitment center
Name of recruitment center
Firoozabadi Hospital
Full name of responsible person
Hamid Khalilian
Street address
Firoozabadi Hosptal, Fadaian Islam St, Shahre Rey
City
Tehran
Province
Tehran
Postal code
1849794113
Phone
+98 21 5590 2070
Email
hkhalilian1410@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keivani
Street address
Shahid Hemmat Highway next to the Milad tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8671
Email
keivani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamid Khalilian
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.193, Zafar St, Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
hkhalilian1410@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nastaran Khosravi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No.193, Zafar St, Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
khosravi.n@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamid Khalilian
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.193, Zafar St, Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
hkhalilian1410@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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