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Investigating the effect of Hordeum vulgare extract bath on neonate jaundice

Protocol summary

Study aim
Determining the effect of washing newborns with traditional Hordeum Vulgare extract on jaundice
Design
A phase 2 clinical trial with control and intervention groups, with parallel groups, without blinding, on 64 infants, using a random number table for randomization.
Settings and conduct
The infants in the intervention group in the POST NICU ward of Shahid Mustafa Khomeini Hospital are washed for three days at 8-9 am, half an hour after breastfeeding, with the interruption of phototherapy, using sterile cotton and barley decoction by a trained nurse in the presence of the mother. Each time, the infant is washed for 5-7 minutes in half a liter of barley water and in a special baby tub, first the hands, then the face and neck, especially behind the ears, chest, lower limbs and finally the baby's back, and dried with a clean and soft cotton towel. Body temperature is measured before and after washing with a mercury thermometer. During the days of hospitalization, both groups of infants are monitored for hypothermia. On these three days, the first and last day, the bilirubin level in the infants' blood is measured, and the urine and feces and weight of the infants are checked.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The baby is full term, The baby weighs between 2.5 and 4 kg, The baby does not have sepsis or another disease. Exclusion criteria: The baby is not full term, The baby weighs less than 2.5 kg or more than 4 kg, The baby has sepsis or another disease.
Intervention groups
32 newborns as the control group (phototherapy) and 32 newborns as the intervention group (phototherapy + Hordeum vulgare decoction bath)
Main outcome variables
Neonate's blood bilirubin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240723062522N1
Registration date: 2025-01-18, 1403/10/29
Registration timing: prospective

Last update: 2025-01-18, 1403/10/29
Update count: 0
Registration date
2025-01-18, 1403/10/29
Registrant information
Name
Melika Sheikhtaheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7748 0753
Email address
melikasheikhtaheri7997@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-07-21, 1404/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Hordeum vulgare extract bath on neonate jaundice
Public title
Investigating the effect of Hordeum vulgare extract bath on neonate jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The neonate should weigh between 2/5 and 4 kg The neonate is full term.
Exclusion criteria:
The neonate have sepsis or other diseases Jaundice in the first two days of birth
Age
From 3 days old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Individual, Using a random number table, There is concealment for the researcher and the research statistician.
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
Medical Ethics committee of Shahed University
Street address
Shahed university, Opposite imam Khomeini Shrine, Persian Gulf highway g
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-09-09, 1403/06/19
Ethics committee reference number
IR.SHAHED.REC.1403.087

Health conditions studied

1

Description of health condition studied
Neonatal jaundice
ICD-10 code
p59
ICD-10 code description
Neonatal jaundice from other and unspecified causes

Primary outcomes

1

Description
Bilirubin in neonate blood
Timepoint
During the three days of washing the neonate with Hordeum vulgare decoction, the amount of bilirubin in the neonate's blood is measured on the first and last day.
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For three days, from 8-9 am, half an hour after feeding, the newborns are washed with sterile cotton and barley water by a trained nurse in the presence of the mother, after stopping phototherapy. The room temperature is set at 28-24 and the temperature of the barley water is set at 37.5 degrees Celsius. Each time, the newborn is washed for 5-7 minutes in half a liter of barley water in a special baby tub, first the hands, then the face and neck, especially behind the ears, chest, lower limbs and finally the baby's back, and dried with a clean and soft cotton towel. The body temperature is measured before and after washing with a mercury thermometer. During the days of hospitalization, the newborns are monitored for hypothermia. During these three days, the bilirubin level in the newborn's blood is measured, and the urine and feces and weight of the newborns are checked.
Category
Treatment - Other

2

Description
Control group: Infants in the control group undergoing phototherapy are monitored for hypothermia during their hospitalization. On these three days, the first and last day, the bilirubin level in the infants' blood is measured, and the infants' urine and feces and weight are checked.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mustafa Khomeini Hospital
Full name of responsible person
Dr. Shive Rafati
Street address
Shahid Mustafa Khomeini Hospital, Italy street, Palestine Square
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 6130
Fax
+98 21 8896 3739
Email
info@mostafahospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Maryam Iranzad Asl
Street address
Shahed university, opposite Imam Khomeini Shrine, Persian Gulf
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Email
m_iranzadasl@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Melika Sheikhtaheri
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Unit 5, No. 12, corner of Shaban Alley, Ghasemzadeh Street, Imamat Square ,Damavand Street
City
Tehran
Province
Tehran
Postal code
1743713734
Phone
+98 21 7748 0753
Email
Melikasheikhtaheri7997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Shiva Rafati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Mustafa Khomeini Hospital, Italy street, Palestine Square
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
009888966130
Email
Dr.shrafati@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Maryam Iranzadasl
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Shahed University, Fars Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Email
m_iranzadasl@yahoo.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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic, scientific and research institutions
Under which criteria data/document could be used
It is allowed to use the data for the purpose of meta-analyses and by preserving all the rights of the creators of this data.
From where data/document is obtainable
By referring to the scientific officer of the research Ms. Dr Shiva Rafati at the email address Dr.shrafati@yahoo.com and the address of Shahed University, Fars gulf highway, Tehran, Tehran Province, Iran. zip code: 3319118651 contact number: 09123879087
What processes are involved for a request to access data/document
The applicant's request will be sent to the mentioned email containing the applicant's profile, the purpose of receiving the data, and the details of the desired data, and it will be checked for compliance of the conditions and data requested with the publication conditions within a maximum of one month, and an appropriate response will be sent.
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