Protocol summary
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Study aim
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Investigating the simultaneous effect of phototherapy with oral zinc sulfate on the amount of bilirubin change in babies with hyperbilirubinemia and the duration of their treatment.
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Design
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The study group are infants without risk factors, which were divided into 2 groups "phototherapy with zinc sulfate" and "phototherapy alonely" based on the sample size of 120 people and randomization by means of boxes of 4 people, and the study was conducted in a double-blind manner, will be done.
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Settings and conduct
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The method of conducting the study is double-blind, which is carried out in the Neonatal and Neonatal Intensive Care Unit of Baharlou Hospital with the blinding of the ward nurse and the parents of the hospitalized baby. The blinding of the study is done by dividing the babies into 4 boxes and determining the intervention for each baby based on the available possibilities and based on rolling the dice which has 6 states, based on which the baby is given zinc sulfate syrup or sucrose.
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Participants/Inclusion and exclusion criteria
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The criteria for the inclusion of infants in the study include all infants with indirect hyperbilirubinemia with pathological total bilirubin levels for age and time of birth. The criteria for the exclusion of infants from the study include those that can affect the result of the study as a confounding factor; For example, liver diseases and all diseases that affect the level of bilirubin, or babies who take supplements containing zinc.
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Intervention groups
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The studied intervention is zinc sulfate (syrup 5 mg per 5 cc), which is administered orally at the rate of 1 mg per kilogram of the baby's body weight for 48 hours.
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Main outcome variables
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The amount of time and frequency required to perform phototherapy if zinc sulfate is prescribed for infants.
General information
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Reason for update
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Updating sample number and study duration
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230914059430N1
Registration date:
2024-01-29, 1402/11/09
Registration timing:
prospective
Last update:
2026-09-14, 1405/06/23
Update count:
1
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Registration date
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2024-01-29, 1402/11/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-02-20, 1402/12/01
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Expected recruitment end date
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2025-08-23, 1404/06/01
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Actual recruitment start date
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2024-08-22, 1403/06/01
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Actual recruitment end date
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2025-11-22, 1404/09/01
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Trial completion date
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2025-11-22, 1404/09/01
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Scientific title
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Investigating the effectiveness of Zinc Sulfate during the duration of the need for Phototherapy in infants with Congenital Jaundice
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Public title
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Investigating the simultaneous effect of Phototherapy with oral Zinc Sulfate on the amount of Bilirubin change in infants with Hyperbilirubinemia and the duration of their treatment in Baharlou Hospital.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
All infants without risk factors born with Neonatal Jaundice
Exclusion criteria:
Lack of parental consent
The presence of major risk factors in the baby, including Cardiovascular, Pulmonary, Renal defects, etc.
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Age
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From 1 day old to 14 days old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
320
Actual sample size reached:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization of the study is done in groups of 4 babies in one box, and according to the 2 possible interventions, 6 modes are considered for these boxes, and the status of each box is determined by throwing a dice.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The mentioned randomization is carried out by the researcher.
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-01-21, 1402/11/01
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1402.575
Health conditions studied
1
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Description of health condition studied
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Congenital Jaundice
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ICD-10 code
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P59
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ICD-10 code description
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Neonatal jaundice from other and unspecified causes
Primary outcomes
1
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Description
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Total Bilirubin
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Timepoint
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Measurement of serum total bilirubin level at the beginning of the study (before the start of the intervention), 24, 48 and 72 hours after the start of oral zinc sulfate intake.
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Method of measurement
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Blood examination
Secondary outcomes
1
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Description
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The duration of receiving phototherapy
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Timepoint
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Up to 14 days after the study
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Method of measurement
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Medical record
2
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Description
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The length of hospitalization
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Timepoint
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Up to 14 days after the study
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Method of measurement
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Medical record
Intervention groups
1
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Description
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Intervention group: Receiving oral zinc sulfate syrup 1 cc/kg, each 5 cc containing 5 mg of zinc while performing phototherapy, which is prescribed for 48 hours.
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Category
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Treatment - Drugs
2
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Description
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Control group: Receiving Phototherapy alonely
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All potential data can be shared after de-identifying individuals after contacting the corresponding author.
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When the data will become available and for how long
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The beginning of the access period from 2026
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To whom data/document is available
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Researchers, Doctors and Health Decision Makers
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Under which criteria data/document could be used
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If any data is not reported in the text of the final report and the addressee needs it, this information will be provided to the requester if it is not about the confidential information of the patients.
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From where data/document is obtainable
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The manager Dr. Ghorbani
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What processes are involved for a request to access data/document
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Contact the project manager
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Comments
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