Investigating the effect of oral melatonin in the treatment of acute respiratory distress syndrome in infants
Design
The current study is a randomized, block-blocked, double-blind clinical trial that includes two control and intervention groups, in which 37 babies will be studied in each group, and finally, the data will be analyzed with spss 16 software. The phase of this study is 3, that is, it compares the results of treatment of people using new treatment and the results of treatment of people using standard treatment. The groups in this study are parallel and two groups are studied during a specific time.
Settings and conduct
Seventy four premature babies weighing less than 2500 grams or gestational age less than 37 weeks born in Imam Reza Hospital Mashhad were randomly divided into two groups, one group was given oral melatonin and standard treatment (surfactant therapy with respiratory support). and in the other group, only standard treatment will be done. The dose of melatonin is 10 mg/kg for three days, which is prescribed once a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: infants with RDS beyond the respiratory distress.
Exclusion criteria include: neonatal sepsis (positive blood culture); respiratory diseases other than RDS (chest x-ray examination); cardiovascular diseases (pulse oximetry examination of the right hand and lower limbs) or diseases of the central nervous system; kidney failure.
Intervention groups
The intervention group will include infants who, in addition to the standard treatment, will be treated with oral melatonin at a dose of 10 mg/kg per day for three days.
The control group will recieve standard treatment (surfactant therapy and respiratory support).
Main outcome variables
The oxidant test, C-reactive protein test (CRP )respiratory distress score of the newborn; the number of surfactant doses are investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130308012743N3
Registration date:2022-11-13, 1401/08/22
Registration timing:registered_while_recruiting
Last update:2022-11-13, 1401/08/22
Update count:0
Registration date
2022-11-13, 1401/08/22
Registrant information
Name
Ezat Khodashenas
Name of organization / entity
Mashhad University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 51 1727 3943
Email address
khodashenase@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral melatonin in the treatment of acute respiratory distress syndrome in neonates
Public title
oral melatonin in the treatment of acute respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with respiratory distress syndrome with any grade of respiratory distress
Exclusion criteria:
Neonatal sepsis
Neonates with Respiratory distress disease other than RSD
Neonates with cardiovascular diseases or diseases of the central nervous system
Neonates with kidney failure
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of infants will be done using block methods. A random sequence will be generated using four blocks of sealedenvelope.com. The envelopes will be printed by the researcher after randomization and will be placed inside the envelopes and the envelope lids will be closed. Envelopes are numbered in random order. Then, we first explain the purpose of the study to the person and he / she will sign the informed consent and receive the intervention based on the envelope number and the order specified in it.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, two groups of people under study, who are infants, and the outcome evaluator were blinded to the way the study was conducted.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Connate of Mashhad University of Medical Sciences
Street address
Qureshi Bul, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2022-05-17, 1401/02/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.154
Health conditions studied
1
Description of health condition studied
Distress syndrome of neonates
ICD-10 code
P22.0
ICD-10 code description
P22.0Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Pro-antioxidant
Timepoint
Laboratory examination is done on the first and third day of birth.
Method of measurement
By measuring pro-antioxidant test
2
Description
C-reactive protein factor (CRP)
Timepoint
Laboratory examination is done on the first and third day of birth.
Method of measurement
By measuring CRP
3
Description
respiratory distress score
Timepoint
Laboratory examination is done on the first and third day of birth.
Method of measurement
By Measuring Respiratory distress score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will include infants who, in addition to the standard treatment, will be treated with oral melatonin at a dose of 10 mg/kg per day for three days.
Category
Treatment - Drugs
2
Description
Control group: They will undergo standard treatment (surfactant therapy and respiratory support).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Farnaz Mousavi
Street address
Ibn Sina Ave, Imam Reza Hospital , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137916616
Phone
+98 51 3852 1121
Email
dr.farnazmousavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Qoreshi Bul, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz Mousavi
Position
Fellowship of neonatology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
dr.farnazmousavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz mousavi
Position
fellowship of neonatology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital, Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
dr.farnazmousavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz Mousavi
Position
neonatology
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital , Ibn Sina Ave, Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91379133169
Phone
+98 51 3852 1121
Fax
Email
dr.darnazmousavi@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
Yes - There is 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
All data can be shared after patients are made unidentified
When the data will become available and for how long
data can be accessible 6 months after results are published
To whom data/document is available
Data can be accessible through an email to the corresponding author
Under which criteria data/document could be used
data will be available for researchers in universities and other scientific institution
From where data/document is obtainable
After sending a request email to the corresponding author data will be sent in 1 month
What processes are involved for a request to access data/document