NeoSCB App for Screening Jaundice in Newborns

Официальное название

Clinical Investigation of the Smartphone App neoSCB to Perform Neonatal Jaundice Screening in Newborn Babies

Обзор

About 60% of babies born after 36 weeks of pregnancy have jaundice during the first two weeks of life. Due to the accumulation of bilirubin in the bloodstream, jaundiced babies appear yellow, which allows healthcare professionals to visually identify significantly jaundiced babies. They will be referred for a blood test to determine if the bilirubin level is so high that treatment such as phototherapy, or more intensive help is required. Left untreated or treatment delayed, jaundice can potentially result in serious brain damage and even death (rare). However, visual inspection of jaundiced babies is inaccurate, often need to unnecessary referrals to hospital blood tests. We have developed the "neoSCB" smartphone app, which accurately detects significant jaundice by taking photographs of the baby's sclera (white part of an eye) and analysing its yellowness using a diagnostic algorithm. The neoSCB app has previously been validated in Ghana involving over 700 newborn babies. In this new study, we will recruit 405 newborn babies with a range of jaundice levels to validate an optimised diagnostic algorithm following our latest research. Two existing commercial screening devices will also be used to investigate whether the app delivers a similar accuracy, at a fraction of the cost. We will enhance the usability of the app and add new features following feedback from patients and healthcare professionals. A health economic study will be conducted to evaluate the economic benefits to the NHS.

Вмешательства

• Диагностический тест Taking photos of a baby's eye
  Taking photos of a baby's eye and using the color of the sclera to estimate the bilirubin level, which determines if the baby is significantly jaundiced.

Первичные конечные точки

• Total serum bilirubin [Срок оценки: The measurement of total serum bilirubin should take less than 10 minutes.]
• Scleral-conjunctival bilirubin [Срок оценки: The measurement of scleral-conjunctival bilirubin should take less than 5 minutes.]

Критерии участия

Критерии включения

• Term newborn babies with and without jaundice (postnatal age 0 day to 28 days)

Критерии исключения

• Newborn babies who are clinically unwell and require urgent medical attention, and babies who have received phototherapy recently

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• UCL Hospitals — London

Публикации

• Leung TS, Outlaw F, MacDonald LW, Meek J. Jaundice Eye Color Index (JECI): quantifying the yellowness of the sclera in jaundiced neonates with digital photography. Biomed Opt Express. 2019 Feb 14;10(3):1250-1256. doi: 10.1364/BOE.10.001250. eCollection 2019 Mar 1. PMID 30891343
• Leung TS, Kapur K, Guilliam A, Okell J, Lim B, MacDonald LW, Meek J. Screening neonatal jaundice based on the sclera color of the eye using digital photography. Biomed Opt Express. 2015 Oct 23;6(11):4529-38. doi: 10.1364/BOE.6.004529. eCollection 2015 Nov 1. PMID 26601015
• Enweronu-Laryea C, Leung T, Outlaw F, Brako NO, Insaidoo G, Hagan-Seneadza NA, Ani-Amponsah M, Nixon-Hill M, Meek J. Validating a Sclera-Based Smartphone Application for Screening Jaundiced Newborns in Ghana. Pediatrics. 2022 Jul 1;150(1):e2021053600. doi: 10.1542/peds.2021-053600. PMID 35656782
• Outlaw F, Nixon M, Odeyemi O, MacDonald LW, Meek J, Leung TS. Smartphone screening for neonatal jaundice via ambient-subtracted sclera chromaticity. PLoS One. 2020 Mar 2;15(3):e0216970. doi: 10.1371/journal.pone.0216970. eCollection 2020. PMID 32119664

Идентификаторы

NCT: NCT06963450 · 157238 · NIHR205460

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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