Clinical trial NCT04962113: 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
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Jaundice
Keywords: tube bath
skin care
phototherapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2021-07-14
Enrollment: 140
Sex: FEMALE
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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.

Primary outcomes:
measure: Sample size
timeFrame: 1-2 month
measure: Divided groups
timeFrame: 1 month
measure: Experiment difining and time
timeFrame: 12 month
measure: Measurement
timeFrame: First, 6-12-24 hours for each nerwborn
measure: Biochemical measurement
timeFrame: First, 6-12-24 hours for each nerwborn
measure: TSB Findings
timeFrame: 10 month
measure: Skin care findings
timeFrame: 10 month
measure: Conclusion
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Serap ÖZDEMİR
Study officials:
References:
citation: Bagwell, G. A., & Steward, D. K. (2020). Hematologic System. Comprehensive Neonatal Nursing Care (6th ed.), Springer Publishing Company, 11C. New York, 315-335.
citation: Association of Women's Health, Obstetric and Neonatal Nurses. (2018). Evidence-Based Clinical Practice Guideline: Neonatal Skin Care (4th ed.). Washington, DC.
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.
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.
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.
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.
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.