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The effect of zinc supplementation on the treatment of neonatal sepsis

Protocol summary

Study aim
To determine the effect of zinc on neonatal sepsis
Design
This was a randomized controlled clinical trial with parallel groups carried out in a single phase on 50 neonates with sepsis.
Settings and conduct
Neonates with sepsis admitted to Bandar Abbas Pediatric Hospital in 2018-2019 were evaluated. Parents were asked to sign an informed consent to participate in the study. Patients were divided into two groups (25 each, as explained in the sampling section). Subsequently dosing and side effects of the drugs were explained to the parents. Neonates were examined on a daily basis. On the 1st day, platelet count, CRP, and CBC diff were measured. In case of normal laboratory results (absence of sepsis), lab tests were repeated 24 hours later, and in case of abnormal results (presence of sepsis), lab tests were repeated after 48 hours and later based on patients' conditions. The antibiotic regimen was individualized according to every patient's clinical condition. Any change in this regimen was recorded. The acquired data were then entered into the SPSS software for statistical analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: neonatal sepsis, gestational age >37 weeks, neonatal age <28 days, parents' informed consent Exclusion criteria: important congenital anomalies, hypoxic ischemic encephalopathy, intracranial hemorrhage, respiratory distress syndrome, candidiasis
Intervention groups
In addition to antibiotics and if there were no contraindications for antibiotics, the intervention group received 1 mg/kg zinc gluconate manufactured by Alhawi (1 mg/ml) orally, via a nasogastric or orogastric tube, twice a day for one week. The control group only received antibiotics.
Main outcome variables
time to the improvement of symptoms, mortality, hospital length of stay

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200810048347N1
Registration date: 2020-12-11, 1399/09/21
Registration timing: retrospective

Last update: 2020-12-11, 1399/09/21
Update count: 0
Registration date
2020-12-11, 1399/09/21
Registrant information
Name
Simin Yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 5010
Email address
siminyazdi.hums@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2019-03-21, 1398/01/01
Trial completion date
2019-04-09, 1398/01/20
Scientific title
The effect of zinc supplementation on the treatment of neonatal sepsis
Public title
The role of zinc supplementation in neonatal sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of at least 2 clinical signs of sepsis including pallor or generalized jaundice, cardiovascular manifestations (tachy- or bradycardia, poor perfusion, or shock), change in body temperature (hypo- or hyperthermia), respiratory manifestations (grunting, intercostal retraction, apnea, or cyanosis), neurologic manifestations (hypotonia, lethargy, irritability, or seizure), gastrointestinal symptoms (abdominal distension, hepatosplenomegaly) CRP >5 mg/ml Presence of at least 1 positive serum parameter based on Fanarrof (book) including WBC <5000/microliter or >25000 at birth or WBC>30000 12-24 hours after birth or WBC>21000 on the second day of birth or the following days, absolute neutrophil count (ANC) <1800/microliter, platelet count <150000/microliter, immature/total (I/T) neutrophil ratio <0.16 on the first day and <0.13 from the second day on. Gestational age >37 weeks Age <28 days Informed consent of the parents
Exclusion criteria:
Important congenital anomalies such as trisomies Hypoxic ischemic encephalopathy Intracranial hemorrhage Respiratory distress syndrome Inborn errors of metabolism Candidiasis
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple randomization Unit of randomization: individual Tools of randomization: Randomization Main software
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 Hormozgan University of Medical Sciences
Street address
Technology and Research Vice-chancellery, East Side of Payambar Azam Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.HUMS.REC.1397.301

Health conditions studied

1

Description of health condition studied
Neonatal sepsis
ICD-10 code
A41
ICD-10 code description
Other sepsis

Primary outcomes

1

Description
Mortality
Timepoint
At the end of the study
Method of measurement
Based on patient's medical chart

Secondary outcomes

1

Description
Time to improvement of clinical symptoms
Timepoint
At the end of the study
Method of measurement
Daily clinical examination

2

Description
Hospital length of stay
Timepoint
At the end of the study
Method of measurement
Based on the patient's clinical charts

Intervention groups

1

Description
Intervention group: the intervention group received 1 mg/kg zinc gluconate manufactured by Alhawi (1 mg/ml) orally, via a nasogastric or orogastric tube, twice a day for one week.
Category
Treatment - Drugs

2

Description
Control group: The control group only received antibiotics.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bandar Abbas Pediatric Hospital
Full name of responsible person
Simin Yazdi
Street address
Bandar Abbas Pediatric Hospital, Imam Khomeini Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7366579158
Phone
+98 76 3366 6242
Email
siminyazdi.hums@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Technology and Research Vice-chancellery, Hormozgan University of Medical Sciences
Full name of responsible person
Nasrin Davari Dolatabadi
Street address
Technology and Research Vice-chancellery, East Side of Payambar Azam Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7379
Email
n.davari@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Technology and Research Vice-chancellery, Hormozgan 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
Bandar Abbas Pediatric Hospital
Full name of responsible person
Simin Yazdi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas Pediatric Hospital, Imam Khomeini Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7366579158
Phone
+98 76 3366 6242
Email
siminyazdi.hums@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandar Abbas Pediatric Hospital
Full name of responsible person
Simin Yazdi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas Pediatric Hospital, Imam Khomeini Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7366579158
Phone
+98 76 3366 6242
Email
siminyazdi.hums@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandar Abbas Pediatric Hospital
Full name of responsible person
Simin Yazdi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas Pediatric Hospital, Imam Khomeini Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7366579158
Phone
+98 76 3366 6242
Email
siminyazdi.hums@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
All collected data will be available after deidentification.
When the data will become available and for how long
Data will be available starting in 2021
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Eligible individuals will be able to use the data for pooled analysis.
From where data/document is obtainable
Via an email address: siminyazdi.hums@gmail.com to Dr. Simin Yazdi.
What processes are involved for a request to access data/document
Within a month of presenting a valid identification card
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