The effect of melatonin on treatment of respiratory distress syndrome and prevention of bronchopulmonary dysplasia
Design
Eighty preterm infants weighing less than 1250 g or gestational age 26 to 32 born in Al-Zahra Hospital were randomly divided into two groups. Informed consent will be given in addition to surfactant at the rate of 5 mg / kg / day for up to three days of melatonin with the surfactant. The clinical trial is a double-blind study.
Settings and conduct
80 neonates, endotracheal surfactant control group, other group endotracheal surfactant and melatonin tablets 5 mg / kg via oral-gastrointestinal tract at Alzahra hospital in Tabriz.
Visiting physicians and nurses caring for neonates are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 80 preterm infants weighing less than 1250 g or gestational age 26 to 32 born at Alzahra Hospital and hospitalized with neonatal respiratory distress syndrome requiring surfactant Will be studied.
Exclusion criteria: Apgar score less than four minutes, evidence of congenital heart disease other than ASD and PDA, evidence of necrotizing enterocolitis prior to surfactant administration, presence of major congenital anomaly, treatment failure, shock, clear chromosomal abnormalities, atrial fibrosis, atresia .
Intervention groups
Newborns are randomly divided into two groups. One group is given intratracheal surfactant and the other group after receiving informed consent in addition to surfactant 5 mg / kg / day up to three days melatonin. It will be prescribed with surfactant.
Main outcome variables
Breathing oxygen fraction: Percentage of oxygen present in infant's nasal air to assess respiratory distress syndrome
Need oxygen or respiratory support for more than 28 days of birth to evaluate bronchopulmonary dysplasia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190518043629N1
Registration date:2020-04-07, 1399/01/19
Registration timing:retrospective
Last update:2020-04-07, 1399/01/19
Update count:0
Registration date
2020-04-07, 1399/01/19
Registrant information
Name
majid fekri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3236 6111
Email address
majid.fekri1362@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-24, 1398/06/02
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Melatonin Efficacy in Treatment of Respiratory Distress Syndrome and Prevention of Bronchopulmonary Dysplasia
Public title
Evaluation of Melatonin Efficacy in Treatment of Respiratory Distress Syndrome and Prevention of Bronchopulmonary Dysplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature Neonates between 26 and 32 weeks of age born at Al-Zahra Hospital
Respiratory distress syndrome requires injection of surfactant
Exclusion criteria:
Less than four minutes Apgar , fewer than four
Evidence of congenital heart disease other than ASD and PDA
Evidence of necrotizing antralocytosis before the administration of surfactant
Congenital major anomalies, heart failure requiring treatment
Shock
Clear chromosomal abnormalities
Esophageal atresia
Diaphragmatic hernia
Age
From 1 day old to 3 days old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The infants were randomly assigned to two groups. A random number list of 1 to 80 will be created using Random number generator and the infants will be randomly assigned to two intervention groups . The 1: 1 block randomization method will be used to achieve two groups with equal sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study,the physician visiting neonates is not aware receiving melatonin by neonates, the nurse who records the patients data and who perform data analysis are blind about study purposes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee for Research in Tabriz University of Medical Sciences
Street address
ARTESH Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.TBZMED.REC.1398.574
Health conditions studied
1
Description of health condition studied
respiratory distres syndrom
ICD-10 code
P22.9
ICD-10 code description
Respiratory distress of newborn, unspecified
2
Description of health condition studied
Bronchopolmonary displasia
ICD-10 code
P27.1
ICD-10 code description
Bronchopulmonary dysplasia originating in the perinatal period
Primary outcomes
1
Description
Bronchopulmonary dysplasia
Timepoint
Requires more than 21% oxygen for at least 28 days
Method of measurement
Fractional oxygen (Fio2) read by blender or ventilator and recorded in the file
Secondary outcomes
1
Description
Respiratory distress syndrome: Symptoms of respiratory distress due to surfactant deficiency mainly caused in preterm infants.
Timepoint
One hour and four hours after treatment and the number of times the surfactant is needed
Method of measurement
Existence of respiratory distress requiring intubation or establishment of NCPAP with at least 5 cm water pressure at first hour of birth with Fractional oxygen (Fio2) requires respiratory fraction greater than 40% at 26 weeks gestation and respiratory fraction greater than 30% at 26 weeks gestation. Or continued respiratory distress, despite the onset of NCPAP, which is diagnosed by a neonatal or pediatric specialist or pediatric resident.
Intervention groups
1
Description
Control group: In this group, the surfactant is injected into the trachea. How to inject Surfactant by Insure, the patient will be intubated and post-injection will be extubated and subjected to N-CPAP but will remain intubated if the respiratory distress and SPO2 are not corrected.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, after obtaining informed consent in addition to the surfactant, 5 mg / kg daily up to three days of melatonin will be administered via NGtube with the surfactant.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital in Tabriz
Full name of responsible person
Majid Fekri
Street address
Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 8947
Email
majid.fekri1362@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3556 6449
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Majid Fekri
Position
neonatal assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Artesh Ave
City
tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3556 9543
Email
majid.fekri1362@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manijeh Mostafa Gharabaghi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3556 9543
Email
gharehbaghimm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Fekri
Position
Neonatal Assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3556 9543
Email
Majid.fekri1362@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome of this study is shared after unidentifiable individuals.
When the data will become available and for how long
After printing and analyzing the results and data available since 2021.
To whom data/document is available
The data of this study are applicable to academic and scientific researchers and medical and paramedical students.
Under which criteria data/document could be used
The data in this study are solely for the use of academic and scientific researchers and medical and paramedical students.
From where data/document is obtainable
Applicants can contact the following people by email:
1. Majid Fekri : majid.fekri1362@gmail.com
2 . Gharehbaghi : gharehbaghimm@yahoo.com
What processes are involved for a request to access data/document
The applicant can contact the Alzahra hospital in Tabriz in person or the e-mail address listed above.