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

I

Istanbul University - Cerrahpasa (IUC)

Status

Completed

Conditions

Newborn Jaundice

Treatments

Other: TUBE BATH

Study type

Interventional

Funder types

Other

Identifiers

NCT04962113
IstanbulUC-Pediatri

Details and patient eligibility

About

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).

Enrollment

140 patients

Sex

Female

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 4 patient groups

Tunnel group Tube bath during the phototherapy
Experimental group
Treatment:
Other: TUBE BATH
Tunnel group rutin care
No Intervention group
LED group Tube bath during the phototherapy
Experimental group
Treatment:
Other: TUBE BATH
LED group rutine care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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