The overall objective of the present study will be to investigate the effect of melatonin supplementation as adjuvant therapy in preterm neonates with neonatal jaundice.
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 60 patients. To randomize the research samples, we will use the limited randomization method of the block randomization type.
Settings and conduct
This study is a randomized and double-blind clinical trial that will be conducted with a focus on preterm infants with neonatal jaundice in Mofid Children's Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Gestational age 32-37 weeks
2. Serum bilirubin level below exchange transfusion threshold
3. Indirect hyperbilirubinemia
4. Postnatal age under 30 days
Exclusion criteria:
1. Underlying diseases and congenital anomalies in the neonate
2. Any signs of neonatal sepsis or other infections
3. Signs and risk factors of hemolysis
4. Acute or chronic respiratory diseases
Intervention groups
The control group neonates will only receive phototherapy, while the case group will receive 5.0 mg/kg/day oral melatonin drops in addition to phototherapy.
Main outcome variables
Serum bilirubin level (mg/dL)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231210060317N1
Registration date:2023-12-24, 1402/10/03
Registration timing:prospective
Last update:2023-12-24, 1402/10/03
Update count:0
Registration date
2023-12-24, 1402/10/03
Registrant information
Name
Farzaneh Ahmadi Khatiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2290 4603
Email address
ahmadikhatiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Melatonin Administration as an Adjuvant Therapy in Preterm Infants with Neonatal Jaundice
Public title
Melatonin Administration as an Adjuvant Therapy in Preterm Infants with Neonatal Jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 32-37 weeks
Serum bilirubin level below exchange transfusion threshold
Indirect hyperbilirubinemia
Postnatal age under 30 days
Exclusion criteria:
Underlying diseases and congenital anomalies in the neonate
Any signs of neonatal sepsis or other infections
Signs and risk factors of hemolysis
Acute or chronic respiratory diseases
Age
From 3 days old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the study samples, we will use restricted randomization, specifically block randomization. All block sizes will be equal, using blocks of 4 (including 2 neonates in the control group and 2 in the melatonin group).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, after explaining the objectives of the research to the parents and obtaining written consent, the infants were randomly assigned to one of the two groups of case and control. Each patient is assigned a code, and parents are unaware of whether their child is in the control group or the case. In the same way, the researcher only had the task of allocating patients to two groups number one and two, and is not aware of the definition of groups one and two. After assigning the patient to one of the desired groups, the necessary intervention is carried out by a specialist in the neonatal department, and the results are evaluated and recorded by the evaluation, which has the task of collecting the results of the results based on the patient's code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Daneshjou Blvd, Shahid Beheshti University of medical sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983535511
Approval date
2023-09-30, 1402/07/08
Ethics committee reference number
IR.SBMU.MSP.REC.1402.371
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.0
ICD-10 code description
Neonatal jaundice associated with preterm delivery
Primary outcomes
1
Description
Serum bilirubin level (mg/dL)
Timepoint
Serum bilirubin levels will be measured in both groups before the intervention (T0), on the first day (T1), and on the second day (T2) after the intervention.
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Neonates in this group will receive 0.5 mg/kg/day oral melatonin drops in addition to phototherapy.
Category
Treatment - Drugs
2
Description
Control group: Neonates in this group will only receive phototherapy.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children's Hospital
Full name of responsible person
Farzaneh Ahmadi Khatiri
Street address
Shariati Ave, Mofid Children Hospital, Neonatology department.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7033
Email
Ahmadikhatiri@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Velenjak, Daneshjou Blvd, Shahid Beheshti University of Medical sciences, Deputy of research and technology.
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2243 9781
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
In this study, after completing the study, all potential data will be shared with other researchers through the Research Gate data-sharing system after de-identifying the patients.
When the data will become available and for how long
Access will start from the time the results are printed.
To whom data/document is available
The data will be publicly available to all interested parties through the link created on the researcher's Research Gate page.
Under which criteria data/document could be used
The use of research data for future studies by referring to the main published article of the present research will be unimpeded.
From where data/document is obtainable
The data will be transparently accessible through the link included in the final article.
What processes are involved for a request to access data/document
The data will be transparently accessible through the link included in the final article.