White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns

January 6, 2026 updated by: Zeynep ÇİFTCİ 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: İntervention group
  1. White fabric will be covered over the incubator for term newborns during phototherapy.
  2. During phototherapy, term newborns will receive a baby massage, including facial massage, chest massage, arm massage, abdominal massage and leg massage, twice a day for 15 minutes.
Other: White cover
  • A white cover will be covered over the incubator during phototherapy.
  • Baby massage will be applied during phototherapy.
Other Names:
  • Newborn massage
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karabuk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zeynep ze ÇİFTCİ DEMİRTAŞ, 1, midwife

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-77192459-050.99-299327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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