Accuracy of TcB Measurements During and After Phototherapy

Kanuni Sultan Suleyman Training and Research Hospital

Status: Completed

Conditions: Neonatal Hyperbilirubinemia

Treatments: Diagnostic Test: serum bilirubin level measurement

Study type: Observational

Funder types: Other

Identifiers

NCT07080398

2021/249

Details and patient eligibility

About

This study aimed to assess the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants undergoing phototherapy. Transcutaneous bilirubin levels were measured from different anatomical sites during and after treatment, and compared to total serum bilirubin levels. The agreement between the two methods was evaluated using Bland-Altman plots.

Full description

This study focused on evaluating the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants who were receiving phototherapy treatment. Transcutaneous bilirubin levels were measured at two different locations - the glabella (forehead) and lower abdomen - while the infants were undergoing phototherapy. These measurements were then compared to total serum bilirubin levels, which is the gold standard for assessing bilirubin levels in the blood.

The researchers used Bland-Altman plots to analyze the agreement between the transcutaneous bilirubin measurements and total serum bilirubin levels.

By comparing the transcutaneous bilirubin measurements to total serum bilirubin levels using Bland-Altman plots, the researchers were able to determine the accuracy of the transcutaneous measurements in this specific population of infants undergoing phototherapy. This information is important for healthcare providers to ensure that they are using the most accurate and reliable method for monitoring bilirubin levels in infants receiving treatment for jaundice.

Enrollment: 90 patients

Sex: All

Ages: 1 hour to 2 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborn infants less than 7 days of life
• Hyperbilirubinemia requiring phototherapy
• Indirect hyperbilirubinemia
• Newborn infants who are born between 35-42 weeks of gestation

Exclusion criteria

• Direct hyperbilirubinemia
• Disease states other than hyperbilirubinemia
• Congenital abnormalities
• Chromosomal abnormalities
• Poor peripheral perfusion
• Edema

Trial design

90 participants in 2 patient groups

term newborns

Description:

term newborns with hyperbilirubinemia requiring phototherapy

Treatment:

Diagnostic Test: serum bilirubin level measurement

late-preterm newborns

Description:

late-preterm newborns with hyperbilirubinemia requiring phototherapy

Treatment:

Diagnostic Test: serum bilirubin level measurement