Determining the effect of melatonin in the prevention of bronchopulmonary dysplasia in infants admitted to the Neonatal intensive care unit Mahdieh Hospital
Design
This study is a randomized clinical trial.
Allocation of samples to intervention and control groups is done by randomization of random blocks.
Settings and conduct
In this study, infants hospitalized in the neonatal intensive care unit are included in the study.
In the intervention group, in addition to the surfactant, melatonin drops at a dose of one tenth of a milligram per kilogram of the baby's weight are administered as oral drops for three days, and in the control group, in addition to the intratracheal surfactant, a placebo drop similar to the use of melatonin is prescribed. The outcome variable is measured before the start of the study, 28 and 56 days after birth.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Premature neonates between 26 and 32 weeks with respiratory distress syndrome need surfactant injection
exclusion criteria: Apgar five minutes less than four
Evidence of necrotizing enterocolitis before surfactant administration
chromosomal disorders, esophageal atresia, diaphragmatic hernia
Evidence of congenital heart diseases other than Atrial Septal Defect and Patent ductus arteriosus
Major congenital anomaly of heart failure requiring treatment
Intervention groups
intervention group: In addition to surfactant, melatonin drops at a dose of 0.1 milligram per kilogram of the baby's weight will be administered as oral drops for three days.
Control group: In addition to intratracheal surfactant, placebo drops similar to melatonin are prescribed.Placebo drops prepared by a pharmacologist and containing normal saline are prescribed.
Main outcome variables
BRONCHOPULMONARY DYSPLASIA
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230526058294N1
Registration date:2023-08-19, 1402/05/28
Registration timing:registered_while_recruiting
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Fatemeh Serati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
f.serati128@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-20, 1402/01/31
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin in the prevention of bronchopulmonary dysplasia in neonates admitted to Neonatal intensive care unit
Public title
The effect of melatonin in the prevention of bronchopulmonary dysplasia in neonates admitted to Neonatal intensive care unit of Mahdieh Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature neonates between 26 and 32 weeks with respiratory distress syndrome need surfactant injection
Exclusion criteria:
Apgar five minutes less than four
Evidence of necrotizing enterocolitis before surfactant administration
chromosomal disorders, esophageal atresia, diaphragmatic hernia
Evidence of congenital heart diseases other than Atrial Septal Defect and Patent ductus arteriosus
Major congenital anomaly of heart failure requiring treatment
Age
From 1 day old to 3 days old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients in two groups was done by random block allocation method.The allocation sequence was generated using the free web system https//:www.sealedenvelope.com.To produce the sequence, the number of subjects in each block is 4, and the letters A are for the intervention group and the letters B are for the control group.Finally, 60 samples (15 blocks) have been produced in two groups A and B.Then, the cards containing the blocks are placed inside the standard envelope and in this way the concealment allocation is observed. Based on the selection of eligible neonates, an envelope is randomly picked by the researcher and the method of allocation is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
The doctor evaluating the outcome does not know how to assign drugs to patients.
After collecting all the samples, the data analyst will analyze the intervention and control groups based on the code made by the pharmacologist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهشهای زیست پزشکی دانشگاه علوم پزشکی شهیدی بهشتی
Street address
Shariati St. Mofid Children's Hospital
City
tehran
Province
Tehran
Postal code
8313774691
Approval date
2023-02-20, 1401/12/01
Ethics committee reference number
IR.SBMU.MSP.REC.1401.640
Health conditions studied
1
Description of health condition studied
bronchopulmonary dysplasia
ICD-10 code
P27.1
ICD-10 code description
Bronchopulmonary dysplasia originating in the perinatal period
Primary outcomes
1
Description
BRONCHOPULMONARY DYSPLASIA
Timepoint
Before initiation of the study, 28 and 56 days after birth
Method of measurement
Inspiratory oxygen fraction:The percentage of oxygen that is present in the air of the newborn, in order to investigate respiratory distress syndrome, the need for oxygen or respiratory assistance for more than 28 days after birth to investigate bronchopulmonary dysplasia
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to surfactant, melatonin drops at a dose of 0.1 milligram per kilogram of the baby's weight will be administered as oral drops for three days.
Category
Treatment - Drugs
2
Description
Control group: In the control group, in addition to intratracheal surfactant, placebo drops similar to melatonin are prescribed.Placebo drops prepared by a pharmacologist and containing normal saline are prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh Hospital
Full name of responsible person
fatemeh serati
Street address
Fadaeiyan Eslam
City
tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
f.serati128@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید بهشتی
Street address
Arabi st, Velenjak st
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
f.serati128@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
fatemeh serati
Position
دکترای تخصصی بالینی
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fadaeiyan Eslam
City
tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
f.serati128@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
fatemeh serati
Position
Clinical Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fadaeiyan Eslam.Mahdiyeh Hospital
City
tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
f.serati128@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
fatemeh serati
Position
Clinical Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fadaeiyan Eslam. Mahdiyeh Hospital
City
tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
f.serati128@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data can be shared potentially after patients became unrecognizable.
When the data will become available and for how long
After completing the results and analyzing the data, access to them is allowed.
To whom data/document is available
Researchers working in academic institutions or research centers
Under which criteria data/document could be used
Researchers are licensed by the research committee
From where data/document is obtainable
After publishing the article, visit the magazine site to get more information write to f.serati128@gmail.com
What processes are involved for a request to access data/document
Researchers can can receive the necessary response after two weeks by sending an e-mail to the person in charge.