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

NCT ID: NCT04962113

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-09-01

Brief Summary

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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).

Detailed Description

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Conditions

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Newborn Jaundice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tunnel group Tube bath during the phototherapy

Group Type EXPERIMENTAL

TUBE BATH

Intervention Type OTHER

Wrap Tube Baht (immersion)

Tunnel group rutin care

Group Type NO_INTERVENTION

No interventions assigned to this group

LED group Tube bath during the phototherapy

Group Type EXPERIMENTAL

TUBE BATH

Intervention Type OTHER

Wrap Tube Baht (immersion)

LED group rutine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TUBE BATH

Wrap Tube Baht (immersion)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Month

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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SERAP ÖZDEMİR

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Serap ÖZDEMİR

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 29223208 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 25844870 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38899824 (View on PubMed)

Other Identifiers

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IstanbulUC-Pediatri

Identifier Type: -

Identifier Source: org_study_id

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