Determining the effect of oral zinc sulfate on serum bilirubin levels in term neonates
Design
This is a parallel randomized controlled clinical trial that will be performed on 128 infants with neonatal hyperbilirubinemia. Randomization in this research is done using blocks with size of 4 using syntax written in SPSS program. The duration of the study will be about 3 months.
Settings and conduct
This study is a clinical trial study with a control group that will be performed on a total of 128 infants referred to Bahar Shahroud Hospital. Patients' parents must sign an informed consent form before entering the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Neonates with a diagnosis of neonatal hyperbilirubinemia;
Existence of indirect hyperbilirubinemia; Infants with a gestational age of 36 to 40 weeks; Birth weight more than 2500 grams; Stable vital signs;
Informed consent of parents to participate in the research. Exclusion criteria: Apgar 5 minutes less than 5; Need for cardiopulmonary resuscitation; Presence of congenital heart, lung and liver malformations; Neonatal meningitis and TORCH infections.
Intervention groups
Patients included in the study are divided into two groups of intervention and control. In the intervention group, treatment with serum therapy, oxygen therapy, standard phototherapy with oral zinc sulfate at a rate of 1 ml per day will be performed. In the control group, treatment as in the intervention group will be prescribed with serum therapy, oxygen therapy and standard phototherapy without zinc sulfate.
Main outcome variables
Indirect bilirubin level and duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N23
Registration date:2020-11-24, 1399/09/04
Registration timing:prospective
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-29, 1399/09/09
Expected recruitment end date
2021-02-17, 1399/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral zinc sulfate on serum bilirubin level in term neonates with jaundice, a clinical trial
Public title
The effect of oral zinc sulfate on jaundice in term infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with a diagnosis of neonatal hyperbilirubinemia;
Existence of indirect hyperbilirubinemia;
Infants with a gestational age of 36 to 40 weeks;
Birth weight more than 2500 grams;
Stable vital signs;
Informed consent of parents to participate in the research.
Exclusion criteria:
Apgar 5 minutes less than 5;
Need for cardiopulmonary resuscitation;
Presence of congenital heart, lung and liver malformations;
Neonatal meningitis;
TORCH infections.
Age
From 3 days old to 15 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated to intervention and control groups according to random allocation table that illustrated by a statistician. Randomization was done using permuted block randomization method (Block size was 4) using blocked random allocation syntax in SPSS software. Sample
size was 128. Study consisted of 32 blocks. Allocation concealment was done using closed opaque envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2020-10-25, 1399/08/04
Ethics committee reference number
IR.SHMU.REC.1399.114
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.8
ICD-10 code description
Neonatal jaundice from other specified causes
Primary outcomes
1
Description
Indirect bilirubin level
Timepoint
Within 24, 48 and 72 hours of starting treatment
Method of measurement
Measurement of bilirubin by Diazo method
2
Description
Duration of hospitalization
Timepoint
On a daily basis from the start of treatment and hospitalization
Method of measurement
Day count from the medical records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After initial and routine procedures including: hospitalization in the neonatal ward and serum therapy and oxygen therapy and stabilization of vital signs, standard photo therapy with oral sulfate at a rate of 1 ml per day will be prescribed.
Category
Treatment - Drugs
2
Description
Control group: For this group, as in the intervention group, only standard phototherapy will be prescribed, while performing initial and routine measures, including hospitalization in the neonatal ward, serum therapy, oxygen therapy, and stabilization of vital signs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar Hospital of Shahroud
Full name of responsible person
Dr. Mahboobeh Mohammadi
Street address
Bahar Hospital., End 22 Bahman street., Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3616633255
Phone
+98 23 3224 5376
Fax
+98 23 3233 3902
Email
m_m361kord@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Sahar Idrom
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahar Hospital, End 22 Bahman street, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3616633525
Phone
+98 23 3224 5376
Fax
+98 23 3233 3902
Email
saharnazzzid.dr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mahboobeh Mohammadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatalogy
Street address
Bahar hospital., End 22 Bahman street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616622355
Phone
+98 23 3224 7653
Fax
+98 23 3233 3902
Email
m_m361kord@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available