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

Primary Purpose

Newborn Jaundice

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TUBE BATH
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Newborn Jaundice focused on measuring tube bath, skin care, phototherapy

Eligibility Criteria

0 Days - 1 Month (Child)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Serap ÖZDEMİR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Tunnel group Tube bath during the phototherapy

Tunnel group rutin care

LED group Tube bath during the phototherapy

LED group rutine care

Arm Description

Outcomes

Primary Outcome Measures

Sample size
The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria.
Divided groups
Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control).
Experiment difining and time
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.
Measurement
Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
Biochemical measurement
Total serum bilirubin values obtained from patient files.
TSB Findings
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.
Skin care findings
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).
Conclusion
Tube bath is suggested that decreasing total serum bilirubin level and maintaining skin integrity and moisture balance.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2021
Last Updated
May 24, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04962113
Brief Title
Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy
Official Title
Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Jaundice
Keywords
tube bath, skin care, phototherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tunnel group Tube bath during the phototherapy
Arm Type
Experimental
Arm Title
Tunnel group rutin care
Arm Type
No Intervention
Arm Title
LED group Tube bath during the phototherapy
Arm Type
Experimental
Arm Title
LED group rutine care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
TUBE BATH
Intervention Description
Wrap Tube Baht (immersion)
Primary Outcome Measure Information:
Title
Sample size
Description
The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria.
Time Frame
1-2 month
Title
Divided groups
Description
Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control).
Time Frame
1 month
Title
Experiment difining and time
Description
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.
Time Frame
12 month
Title
Measurement
Description
Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
Time Frame
First, 6-12-24 hours for each nerwborn
Title
Biochemical measurement
Description
Total serum bilirubin values obtained from patient files.
Time Frame
First, 6-12-24 hours for each nerwborn
Title
TSB Findings
Description
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.
Time Frame
10 month
Title
Skin care findings
Description
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).
Time Frame
10 month
Title
Conclusion
Description
Tube bath is suggested that decreasing total serum bilirubin level and maintaining skin integrity and moisture balance.
Time Frame
12 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Serap ÖZDEMİR
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Bagwell, G. A., & Steward, D. K. (2020). Hematologic System. Comprehensive Neonatal Nursing Care (6th ed.), Springer Publishing Company, 11C. New York, 315-335.
Results Reference
background
Citation
Association of Women's Health, Obstetric and Neonatal Nurses. (2018). Evidence-Based Clinical Practice Guideline: Neonatal Skin Care (4th ed.). Washington, DC.
Results Reference
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PubMed Identifier
29223208
Citation
Brogan J, Rapkin G. Implementing Evidence-Based Neonatal Skin Care With Parent-Performed, Delayed Immersion Baths. Nurs Womens Health. 2017 Dec;21(6):442-450. doi: 10.1016/j.nwh.2017.10.009.
Results Reference
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Citation
Dağ, Y. S., & Yayan, E. H. (2019). The Effect on Bilirubin Levels of Massage, Tub Bath, and Sponge Bath in Newborns with Hyperbilirubinemia: A Randomized ControlLed Trial. European Journal of Integrative Medicine, 27, 70-74.
Results Reference
background
Citation
Kaplan, M., Wong, RJ., Burgis, JC., Sibley E., Stevensen, DK. (2020). Neonatal Jaundice and Liver Diseases, Martin RJ, Fanoroff AA, Walsh MC, Fanaroff and Martin's Neonatal-Perinatal Medicine in 11th Edition, Philadelphia, 91:1788-1852.
Results Reference
background
Citation
Mohammadi Pirkashani, L., Asghari, G., Marofi, M., & Barekatain, B. (2017). Effect of Chicory Extract Bath on Neonatal Bilirubin Levels: A Randomized Clinical Trial Study. International Journal of Pediatrics, 5(12), 6679-6688.
Results Reference
background
PubMed Identifier
25844870
Citation
Sherbiny HS, Youssef DM, Sherbini AS, El-Behedy R, Sherief LM. High-intensity light-emitting diode vs fluorescent tubes for intensive phototherapy in neonates. Paediatr Int Child Health. 2016 May;36(2):127-33. doi: 10.1179/2046905515Y.0000000006.
Results Reference
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Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy

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