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

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Completed
CT.gov ID
NCT04962113
Collaborator
(none)
140
1
4
10
14

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: TUBE BATH
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tunnel group Tube bath during the phototherapy

Other: TUBE BATH
Wrap Tube Baht (immersion)

No Intervention: Tunnel group rutin care

Experimental: LED group Tube bath during the phototherapy

Other: TUBE BATH
Wrap Tube Baht (immersion)

No Intervention: LED group rutine care

Outcome Measures

Primary Outcome Measures

  1. Sample size [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 [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 [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 [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 [First, 6-12-24 hours for each nerwborn]

    Total serum bilirubin values obtained from patient files.

  6. TSB Findings [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 [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 [12 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Days to 1 Month
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Serap ÖZDEMİR Gaziantep Turkey 27000

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
SERAP ÖZDEMİR, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT04962113
Other Study ID Numbers:
  • IstanbulUC-Pediatri
First Posted:
Jul 14, 2021
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by SERAP ÖZDEMİR, Principal Investigator, Istanbul University-Cerrahpasa
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022