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Набира участници Не е приложимо NCT06647225

Using Artificial Intelligence to Screen for Hip Dysplasia

Не е приложима фаза (напр. обсервационно)
Заболявания: Developmental Dysplasia of Hip

Спонсор: Murdoch Childrens Research Institute

Налично на: БГ
Обобщение
The goal of this clinical trial is to learn if an ultrasound scan using artificial intelligence can accurately screen for hip dysplasia. Researchers will compare the artificial intelligence ultrasound results to the standard ultrasound measures to see if the artificial intelligence ultrasound scan can accurately screen for hip dysplasia. It will also seek to understand how parents feel about their children undergoing this scan. Participants will: * Have an additional ultrasound performed on their child at their scheduled outpatient's appointment for hip dysplasia * Complete a short questionnaire about the experience of having the measurement performed on their child
Описание
Initial screening for Developmental Dysplasia of the Hip (DDH) in Australia is performed most often by general practitioners and paediatricians shortly after birth and by maternal child health care nurses (MCHN) throughout the first year of life. These physical examinations consist of the Ortolani and Barlow tests and the examination of the thigh and gluteal creases. A recent meta-analysis reported the sensitivity of these tests as 36%, which indicates there is potential for a large proportion of cases to go undetected when solely relying on these examinations. Moreover, there currently are no formalised processes by which standards of practice are taught, assessed, or maintained. Thus, there is a clear need for a less operator-dependent screening protocol that can be performed within the current models of infant care. While some countries utilise universal ultrasound screening, this too is limited by access to care, as devices are not portable and thus cannot be used in current care models. Furthermore, it requires a specialist operator, substantially increasing cost. The screening program's limited nature, combined with the need for more consensus among international healthcare providers regarding the best method for managing DDH, has produced highly mixed clinical practices. One part of the solution is optimising screening protocols for DDH in existing care models. Each state in Australia has established MCHN care protocols that provide access care for young children. While physical screening for DDH in these visits is standard practice, there remains considerable scope for improvement in the accuracy and reliability of these screening methods. Selective screening relies on several clinical associations with DDH to identify which patients receive ultrasound screening. Still, it has been shown to detect only 50% of infants with dysplasia. The MCHN screening program relies on clinical examination alone to detect dysplasia, an inferior identification method. Universal screening has a higher rate of detection of dysplasia but is expensive, single point in time (so misses the development of dysplasia) and results in higher levels of treatment. A possible solution is portable artificial intelligence (AI)-augmented ultrasound. Recently technology has been developed to support a portable ultrasound device to screen DDH that uses AI-enabled technology to screen for DDH rapidly and accurately. Prior data has demonstrated that physicians and nurses could operate the device following training from expert sonographers. With its low-cost and ease of operation (with simple training) by healthcare providers such as MCHNs, it could significantly augment the physical screening. Thus, there is clear potential for an affordable, repeatable, and accessible screening methodology to be translated into clinical care. Initial Canadian data is promising. Pilot data suggests that DDH detection rates with this technology is on par with the detection rates of orthopaedi
Кой може да участва
Inclusion Criteria: * Enrolled in the VicHip study * Is 4-20 weeks of age at enrolment * Is attending The Royal Children's Hospital for the purpose of the potential diagnosis of DDH * Has a diagnostic (standard) hip ultrasound on the day of their out-patient appointment * Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Exclusion Criteria: Participants will be excluded from enrolment if: • They are currently receiving treatment for DDH
Места на провеждане 1
Австралия (1)
Royal Children's Hospital
Parkville , Victoria
Natalie K Hyde, BBiomedSc, PhD
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
4 Weeks
Максимална възраст
20 Weeks
Здрави доброволци
Не
Начална дата
06.12.2024
Крайна дата
01.11.2026
Регистрационен номер
NCT06647225
Източник
anzctr
Запитване за медицински туризъм

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