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

NCT04962113 | Completed DMC

• 1 other identifier: IstanbulUC-Pediatri
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Newborn Jaundice

Keywords

tube bath; skin care; phototherapy

Outcome Measures

Primary Outcomes (8)

• 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.

  1-2 month

• Divided groups

  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

  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

  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

  Total serum bilirubin values obtained from patient files.

  First, 6-12-24 hours for each nerwborn

• 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.

  10 month

• 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).

  10 month

• Conclusion

  Tube bath is suggested that decreasing total serum bilirubin level and maintaining skin integrity and moisture balance.

  12 month

Study Arms (4)

Tunnel group Tube bath during the phototherapy

EXPERIMENTAL

Other: TUBE BATH

Tunnel group rutin care

NO INTERVENTION

LED group Tube bath during the phototherapy

EXPERIMENTAL

Other: TUBE BATH

LED group rutine care

NO INTERVENTION

Interventions

TUBE BATH OTHER

Wrap Tube Baht (immersion)

LED group Tube bath during the phototherapy; Tunnel group Tube bath during the phototherapy

Eligibility Criteria

• Age: 0 Days - 1 Month
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Serap ÖZDEMİR

Gaziantep, 27000, Turkey (Türkiye)

Location

Related Publications (8)

• Bagwell, G. A., & Steward, D. K. (2020). Hematologic System. Comprehensive Neonatal Nursing Care (6th ed.), Springer Publishing Company, 11C. New York, 315-335.

  BACKGROUND

• Association of Women's Health, Obstetric and Neonatal Nurses. (2018). Evidence-Based Clinical Practice Guideline: Neonatal Skin Care (4th ed.). Washington, DC.

  BACKGROUND

• 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.

  PMID: 29223208 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25844870 BACKGROUND

• Ozdemir S, Balci S. The Effect of Tub Bathing on the Skin and Bilirubin Levels of Babies Receiving Tunnel and Light-Emitting Diode Phototherapies: A Randomized Controlled Trial. Adv Skin Wound Care. 2024 Jul 1;37(7):1-9. doi: 10.1097/ASW.0000000000000163.

  PMID: 38899824 DERIVED

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 14, 2021
• Study Start: November 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 15, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)