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Effect of Bathing on Physiological Parameters, Skin, Bilirubin and Comfort Levels in Infants Receiving Phototherapy

S

Selcuk University

Status

Enrolling

Conditions

Phototherapy Skin Rash

Treatments

Other: Newborn bathing

Study type

Interventional

Funder types

Other

Identifiers

NCT06819150
2023/78_TR

Details and patient eligibility

About

The aim of this study is to determine the effect of bathing on physiological parameters (heart rate, body temperature and oxygen saturation), skin, bilirubin and comfort level in infants receiving phototherapy.

Full description

Neonatal jaundice (hyperbilirubinemia) causes a yellowish discolouration of the sclera and skin due to increased levels of bilirubin in the blood. Jaundice develops in 60% of term babies and 80% of premature babies in the first week of life. Currently, the appropriate treatment option for neonatal jaundice is phototherapy. Phototherapy treatment reduces bilirubin concentrations through various photochemical reactions that allow bilirubin to be excreted more easily. However, phototherapy treatment is associated with short-term side effects including transient skin rashes, diarrhoea, hyperthermia and dehydration.

Physiological reasons such as the weak connection between the epidermis and dermis layer in the skin of the newborn, the pH value of the skin being close to neutral or alkaline, and the low melanosome production increase the susceptibility of the newborn to infection and skin damage. Invasive interventions, use of antiseptics, phototherapy and various instruments may disrupt the skin integrity of the newborn. Therefore, all newborns receiving treatment and care in the neonatal intensive care unit are at risk in terms of skin integrity.

In the majority of newborn infants; jaundice develops, which can affect the newborn neurologically, motor and hearing if left untreated,. Phototherapy devices are widely used today for the treatment of jaundice. Phototherapy devices used in the treatment of jaundice have side effects such as skin rashes, diarrhea, dehydration and hyperthermia. In the literature reviewed, results were found that bathing the newborn reduces phototherapy rashes, lowers the bilirubin level and increases the comfort of the newborn. Also in the literature; There are studies showing that one of the most suitable bathing methods for a newborn is bathtub bathing and that bathing with baby shampoo is not harmful to the newborn.

Enrollment

60 estimated patients

Sex

All

Ages

1 to 28 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Born at 35-41 gestational weeks
  • Indirect hyperbilirubinaemia diagnosed at 24 hours of birth or more,
  • No health problems,
  • Indication for phototherapy treatment
  • Stable vital signs
  • Whose parents agreed to participate in the study

Exclusion criteria

  • Newborns with ABO and Rh incompatibility,
  • Direct diagnosis of hyperbilirubinaemia,
  • Congenital anomaly,
  • With skin lesions

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Newborn bathing
Experimental group
Description:
The term and preterm infants in the experimental group will have a bathtub bath before starting phototherapy treatment.
Treatment:
Other: Newborn bathing
Standard of care
No Intervention group
Description:
No intervention other than routine clinical practices will be applied to the control group.

Trial contacts and locations

1

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Central trial contact

Raziye Çelen, Asst. Prof.; Perihan B Çalışkan, MSc student

Data sourced from clinicaltrials.gov

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