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Completed

NCT Number: NCT04962113

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

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).

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Key information

Conditions

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

Age range

0 day–1 month

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Serap ÖZDEMİR

Gaziantep, 27000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TUBE BATH

Other

Wrap Tube Baht (immersion)

Primary outcomes

  1. Sample size

    Time frame: 1-2 month

    The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria.

  2. Divided groups

    Time frame: 1 month

    Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control).

  3. Experiment difining and time

    Time frame: 12 month

    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.

  4. Measurement

    Time frame: First, 6-12-24 hours for each nerwborn

    Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).

  5. Biochemical measurement

    Time frame: First, 6-12-24 hours for each nerwborn

    Total serum bilirubin values obtained from patient files.

  6. TSB Findings

    Time frame: 10 month

    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.

  7. Skin care findings

    Time frame: 10 month

    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).

  8. Conclusion

    Time frame: 12 month

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

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2021
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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