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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04962113
Enrollment
140
Registered
2021-07-14
Start date
2019-11-01
Completion date
2020-09-01
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Jaundice

Keywords

tube bath, skin care, phototherapy

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).

Interventions

OTHERTUBE BATH

Wrap Tube Baht (immersion)

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
0 Days to 1 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Divided groups1 monthThirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control).
Experiment difining and time12 monthThe 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.
Sample size1-2 monthThe sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria.
MeasurementFirst, 6-12-24 hours for each nerwbornData were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
Biochemical measurementFirst, 6-12-24 hours for each nerwbornTotal serum bilirubin values obtained from patient files.
TSB Findings10 monthWhen 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 findings10 monthSkin 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).
Conclusion12 monthTube bath is suggested that decreasing total serum bilirubin level and maintaining skin integrity and moisture balance.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026