Determining the effect of bath with marshmallow on bilirubin level of neonates with jaundice
Design
The infants who meet the inclusion criteria will be selected and then, by drawing lots and using even and odd numbers, 30 infants will be placed in the intervention group (phototherapy and bath with marshmallow) and 30 infants will be placed in the control group (phototherapy).
Settings and conduct
In the neonatal ward of Ali Ibn Abi Talib Hospital in Rafsanjan
Participants/Inclusion and exclusion criteria
1- Jaundice based on the doctor's diagnosis and serum total bilirubin 13 mg / dL and above
2- Do not suffer from underlying diseases
3- Total serum bilirubin 16 mg per deciliter and above
4- No ABO or RH incompatibility, no G6PD enzyme disorder and no positive Coombs test
5- Absence of physical anomalies in physical examination
6- Does not have any risk factors such as hemolysis, sepsis, asphyxia
7- No history of skin allergies in family members or any allergies to marshmallows
8- Term baby (over 38 weeks)
9- Weight over 2500 kg
Intervention groups
Grind 5 grams of marshmallow and put it in a liter of cold water for 8 hours, then add the extract in a liter of water with a temperature of 37 to 37.5, which is continuously measured by a thermometer. The room temperature is between -28. Set to 24 ° C.
Before starting phototherapy, the infant is bathed with marshmallow once a day for 5 days (5 to 7 minutes) and the infant's body temperature is monitored again. Will be placed).
Main outcome variables
Change in bilirubin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210526051411N1
Registration date:2021-12-11, 1400/09/20
Registration timing:registered_while_recruiting
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Neda Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3247 4440
Email address
neda.rahimi90@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Althaea rosea batching on bilirubin levels of neonates with hyperbilirubinemia
Public title
Effect of Althaea rosea batching on bilirubin levels of neonates with hyperbilirubinemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Jaundice based on the doctor's diagnosis and serum total bilirubin 13 mg / dL and above
Do not suffer from underlying diseases
Total serum bilirubin 16 mg per deciliter and above
No ABO or RH incompatibility, no G6PD enzyme disorder and no positive Coombs test
Absence of physical abnormalities in physical examination
Does not have any risk factors such as hemolysis, sepsis, asphyxia
No history of skin allergies in family members or any allergies to marshmallows
Term baby (over 38 weeks)
Weight over 2500 kg
Exclusion criteria:
Increased jaundice that requires blood transfusion
Withdrawal of the baby's parents to continue participating in the research
Discharge or death of the infant before the end of the intervention period
The baby becomes ill during the course of the disease and during the study, which for any reason contradicts the intervention.
Age
From 1 day old to 10 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, first, neonates with icterus whose disease is approved by a doctor and are admitted to the neonatal ward of Ali Ibn Abitaleb Hospital in Rafsanjan will be identified. Then, in order to randomly assign the infants to the phototherapy and phototherapy groups with a marshmallow bath, a coin toss (milk line) will be used. . The coin toss results are then recorded on a note sheet.
The doctor will also start the treatment based on the results.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is two-blind so that both the baby's parents and the person collecting and analyzing the information of the type of intervention and in which group the baby is placed have no information.
Newborns are admitted to different rooms.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Nurse Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2020-11-28, 1399/09/08
Ethics committee reference number
IR.RUMS.REC.1399.201
Health conditions studied
1
Description of health condition studied
jaundice
ICD-10 code
R17
ICD-10 code description
Unspecified jaundice
Primary outcomes
1
Description
Bilirubin level
Timepoint
Before and after the study
Method of measurement
Photometry (by Juandice method
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, grind 5 grams of Althaea officinalis and put it in one liter of cold water for 8 hours, then take the flower extract with a strainer and then take the extract in a liter of water with a temperature of 37 to 37.5, which is continuously measured by a thermometer. we will add. The room temperature is also set between 28-24 ° C. At the beginning of admission and before the start of phototherapy, the baby is bathed with .The baby is bathed by Althaea officinalis a trained person. The hands are thoroughly washed before the intervention. The baby's body temperature is also measured by the Beurer GmbH digital thermometer made in Germany. The baby's body is washed step by step in 5 to 7 minutes.First, the neck area, especially the area behind the baby's ears, then the chest and upper limbs, abdomen and lower limbs, and finally the baby's back will be washed. At the end, the baby's body is dried with a clean, soft towel and the baby's body temperature is checked again, and the baby is placed under phototherapy with the XHZ model (one week before the sampling of the devices are calibrated). Once an hour, according to the routine of the neonatal serum bilirubin section, it is measured by photometric method (Juandice method in the accredited laboratory of the same hospital and is continuously entered in the data collection and registration form.
Category
N/A
2
Description
Control group: In the control group, only phototherapy Phototherapy with XHZ device is performed routinely
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal ward of Ali Ibn Abi Talib Hospital in Rafsanjan
Full name of responsible person
Neda Rahimi
Street address
Ali Ibn Abi Talib Street
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0001
Email
Aliebn@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Ali Ibn Abi Talib Street
City
rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0097
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Neda Rahimi
Position
Instructor of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nurse Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
34255900
Email
neda.rahimi90@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Neda Rahimi
Position
Instructor of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nurse Street
City
Ransanjan
Province
Kerman
Postal code
7718796755
Phone
34255900
Email
nedarahimi90@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Neda Rahimi
Position
Instructor of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nurse Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
34255900
Email
neda.rahimi90@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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available