Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy

May 24, 2022 updated by: SERAP ÖZDEMİR, Istanbul University - Cerrahpasa (IUC)
The study was conducted as a randomized controlled study to determine effect of tube bathing on skin and bilirubin levels in infants undergoing tunnel and LED of phototherapy. The population of the study consisted of term babies with the diagnosis of hyperbilirubinemia in Gaziantep Cengiz Gökçek Maternity and Pediatrics Hospital and Kilis State Hospital Neonatal Intensive Care Units (NICU) among November 2019-September 2020. The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria. Accordingly, Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control). The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units. Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

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

  • Turkey
      • Gaziantep, Turkey, 27000
        • Serap ÖZDEMİR

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

1 second to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The baby is receiving phototherapy due to physiological hyperbilirubinemia,
  • Being a term newborn,
  • Monitoring of the LED group in the incubator and the tunnel group in the tunnel phototherapy device,
  • Parents' consent to participate in the study.

Exclusion Criteria:

  • Rh incompatibility between mother and baby,
  • Finding ABO non-compliance,
  • Positive direct Coombs test,
  • Presence of congenital anomaly or syndrome,
  • Any surgical intervention has been or will be made,
  • Having any skin lesions,
  • The need for mechanical ventilation.

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: Tunnel group Tube bath during the phototherapy
Other: TUBE BATH
Wrap Tube Baht (immersion)
No Intervention: Tunnel group rutin care
Experimental: LED group Tube bath during the phototherapy
Other: TUBE BATH
Wrap Tube Baht (immersion)
No Intervention: LED group rutine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sample size
Time Frame: 1-2 month
The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria.
1-2 month
Divided groups
Time Frame: 1 month
Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control).
1 month
Experiment difining and time
Time Frame: 12 month
The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units.
12 month
Measurement
Time Frame: First, 6-12-24 hours for each nerwborn
Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
First, 6-12-24 hours for each nerwborn
Biochemical measurement
Time Frame: First, 6-12-24 hours for each nerwborn
Total serum bilirubin values obtained from patient files.
First, 6-12-24 hours for each nerwborn
TSB Findings
Time Frame: 10 month
When differences regarding decrease in 24-hour total serum bilirubin (TSB) levels were compared in all relevant experimental groups, statistically differences were observed (p˂ .001). In particular, the levels of bilirubin were listed as LED-trial, Tunnel-trial, Tunnel-control and LED-control, respectively. It is worthy to utter herein that the decline in TSB was more notable in bathing groups.
10 month
Skin care findings
Time Frame: 10 month
Skin integrity and moisture balance were better in bathing groups than control groups, the best was in the Tunnel-experimental group and the worst was in the Tunnel-control group (p˂ .001).
10 month
Conclusion
Time Frame: 12 month
Tube bath is suggested that decreasing total serum bilirubin level and maintaining skin integrity and moisture balance.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC-Pediatri

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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