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NCT Number: NCT06232174

Value of Transcutaneous Bilirubin Devices

The goal of this observational study is to compare the value of transcutaneous bilirubin devices versus serum bilirubin in jaundiced neonates

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Key information

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, Egypt

Location contact

marina farah fawzy, master

PRINCIPAL_INVESTIGATOR

About this study

Neonatal jaundice, commonly found in 60% of normal newborns, is normally a self-resolving episode ending 72 to 96 h after birth. Transient elevation of blood bilirubin occurs by combination of an increase in red blood cell destruction and concomitant decrease in hepatic bilirubin conjugation. (1) Visible jaundice is present in most term and near-term newborns during the first week of life. Although it is mostly a benign condition, healthcare professionals should keep in mind rare but severe adverse outcomes of serious hyperbilirubinemia (2). Newborn infants must be monitored to identify those who might develop severe hyperbilirubinemia and, in rare cases, acute bilirubin encephalopathy or kernicterus.Kernicterus is associated with a high mortality rate and survivors usually suffer from complications such as athetoid cerebral palsy, highfrequency hearing loss and intellectual disability(3).

Severe neonatal hyperbilirubinemia and its sequelae can be prevented with appropriate serum bilirubin monitoring and early treatment involving phototherapy or exchange blood transfusion (4). In the 2004 American Academy of Pediatrics Subcommittee on Hyperbilirubinemia guideline, total serum bilirubin (TSB) or transcutaneous bilirubin (TcB) measurement is recommended before discharge from the maternity hospital to evaluate the risk of subsequent severe hyperbilirubinemia in all newborns (5). To measure bilirubin levels, the total serum bilirubin (TSB) measured by the biochemical laboratory is still considered a gold standard, but it is invasive, requiring needle pricks that carry the risk for iatrogenic anemia, puncture site infection, bacteremia, and osteomyelitis, and cause pain and stress to the neonates(6). The turn around time for bilirubin test results may delay the initiation of therapy for neonatal hyperbilirubinemia. In recent years, the transcutaneous bilirubinometer, which uses photometry to detect bilirubin levels, has been used as an alternative to estimate the bilirubin levels(4). TcB meters estimate total serum or plasma bilirubin using multiwave length spectral reflection from the skin surface.(7) Transcutaneous bilirubinometry (TcB) developed due to several converging influences and factors as the recognition that yellow skin color is due to the deposition of bilirubin,1 a chromophore molecule that, with advancements in optical science, could be quantitatively measured(8). Transcutaneous bilirubinometry (TcB) has the following advantages ease of use, non-invasive nature and reduction in the number of inpatient TSB determinations reduced expense when compared to a serum bilirubin, immediate results, and superior performance over visual assessment of jaundice. The first attempt at non-invasive measurement of bilirubin goes back to the 1960's when the icterometer was introduced. This device, based on reflectance, had poor analytical specificity and sensitivity, and poor reproducibility with coefficient of variations ranging between 20 and 40%. In the past years, bilirubinometers have gradually been improved and are now based on simultaneous multiple wavelength analysis (9)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • They were born between 35 and 42 weeks of gestation, had a birth weight of more than 2 kg, and were aged between 0 days and 28 days

Exclusion criteria

  • Exclusion criteria are severely ill neonates, neonates with a lethal congenital malformation, and or had skin disease, had received phototherapy before, and received exchange transfusion.

Treatment and study plan

Primary outcomes

  1. diagnostic accuracy of transcutaneous bilirubin devices as a diagnostic test for hyperbilirubinaemia in newborns

    Time frame: 20 days

    diagnostic test accuracy studies comparing TcB and TsB measurement for hyperbilirubinaemia in newborns

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Farah Fawzy Gad, Master

CONTACT

[email protected]

01069928577

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Study of the Value of Transcutaneous Bilirubin Devices in Jaundiced Newborns at Assiut University Children's Hospital

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2024
Registry last updated
Jul 30, 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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