- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06209489
White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns
April 18, 2024 updated by: Zeynep DEMİRTAŞ, Karabuk University
The Effect of White Cover and Massage Application on Bilirubin Level and Duration of Phototherapy in Newborns Undergoing Phototherapy
This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns receiving phototherapy.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Hyperbilirubinemia is a common problem seen in the neonatal period, characterized by yellow staining of the skin and sclera, causing an increase in total serum bilirubin >5 mg/dl.
Neonatal jaundice is seen in 60% of term newborns and 80% of preterm newborns.
Hyperbilirubinemia is usually physiological and disappears within a few days.
Jaundice may worsen and lead to kernicterus (accumulation of bilirubin in some parts of the brain) or death if pathological hyperbilirubinemia occurs.
Therefore, every baby with hyperbilirubinemia and high serum bilirubin levels requires serious attention and treatment.
The primary treatment for neonatal jaundice is phototherapy.
The effectiveness of phototherapy depends on the phototherapy light source, light intensity, distance between the phototherapy light and the newborn, and the body surface area exposed to the light.
Phototherapy has potential side effects in newborns such as hyperthermia, dehydration, diarrhea, bronze baby syndrome, and skin burns.
For this reason, the use of phototherapy should be minimized and solutions should be found to shorten the duration of phototherapy.
To increase the effectiveness of phototherapy treatment, a reflector material can be added to the phototherapy.
White fabric, which can be used as a reflector, can reflect scattered phototherapy light.
When fabrics made of reflective materials are hung over the phototherapy device, they can capture the light that may scatter from the baby to the environment and reflect the light back to the baby.
White fabric may increase irradiance and therefore lead to increased bilirubin conversion.Studies have reported that massage applied before phototherapy is effective in reducing the bilirubin level in babies with hyperbilirubinemia.
Bilirubin is eliminated from the body through defecation.
Removing bilirubin from the body reduces jaundice.
Massage reduces bilirubin levels by increasing the frequency of bowel movements in newborn babies.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Karabük, Turkey
- Recruiting
- Karabuk University
-
Contact:
- Zeynep DEMİRTAŞ, Midwife
- Phone Number: +905076339774
- Email: zeynepciftcidemirtas@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Term babies with gestational age between 37-42 weeks,
- Does not have a respiratory, cardiovascular, gastrointestinal or neurological disorder or syndrome that would prevent or complicate oral feeding,
- Birth weight of 2500 g and above,
- With phototherapy indication,
- Do not have any health problems other than neonatal jaundice detected in the prenatal period,
- Those with a stable health condition,
- Orally fed,
- No clinical signs of dehydration,
- Do not have any skin problems that would prevent baby massage,
- Newborns with written and verbal informed consent from their families will be included in the study.
Exclusion Criteria:
- Premature,
- Those with congenital malformations,
- Those with hyperbilirubinemia requiring exchange transfusion,
- Those with Rh hemolytic disease,
- Having a positive culture test (sepsis),
- Those with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
- Birth weight below 2500 grams,
- Those who were referred to another center during the research,
- Discharged early,
- Unexpected complications developed during the research,
- Bronze child syndrome occurs during phototherapy,
- Newborns who develop a pathology that will prevent or complicate oral feeding will not be included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: İntervention group
|
Other Names:
|
No Intervention: Control group
The hospital's clinical routine will be applied to the newborns in the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
White cover
Time Frame: 24 hours
|
A white cover will be covered over the incubator during phototherapy.
|
24 hours
|
Newborn massage
Time Frame: 2 times 15 minutes at 12 hour intervals
|
Baby massage will be applied during phototherapy.
|
2 times 15 minutes at 12 hour intervals
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Estimated)
June 25, 2024
Study Completion (Estimated)
July 25, 2024
Study Registration Dates
First Submitted
December 30, 2023
First Submitted That Met QC Criteria
January 8, 2024
First Posted (Actual)
January 17, 2024
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77192459-050.99-299327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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