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临床试验/NCT07794644
NCT07794644尚未招募不适用

Improving Screening for Developmental Dysplasia of the Hip Using Artificial Intelligence Ultrasound Scans in Neonates: A Pilot Study

Murdoch Childrens Research Institute0 个研究点目标入组 100 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Feasibility of the AI-ultrasound method as determined by a study-specific questionnaire administered to care givers at Day 1

研究概览

简要总结

The goal of this trial is to pilot a portable ultrasound device that uses artificial intelligence to screen for hip dysplasia. Researchers will gather data to understand the feasibility of performing a larger trial in birthing hospitals. It will also seek to collect initial data on how well the scan compares to the standard hip screening performed soon after birth.

Participants will:

  • Have the portable ultrasound performed on their baby before they are discharged from hospital
  • Have a diagnostic ultrasound performed on their baby at 6-weeks of age
  • Complete a short questionnaire about the experience of having the measurement performed on their baby

详细描述

A recent study by our team showed that at The Royal Women's Hospital, Melbourne, screening at birth using the standard combination of neonatal hip examination and risk-based referral for ultrasound failed to detect 52% (n=100) of cases of Developmental Dysplasia of the Hip (DDH) and that 98.5% (n=2,637) of infants undergoing a screening ultrasound, due to perceived increased risk, do not have DDH. Further, this research team replicated in a regional setting at University Hospital, Geelong in Victoria (n=1,207), that 55.6% of cases of DDH were missed, and of those sent for diagnostic ultrasound scans 92.5% did not have DDH (unpublished data). Together, this means many infants are being scanned, but an unacceptably high proportion of cases are still being missed.

Late detected dysplasia is often resistant to conservative treatment. This form of dysplasia is unpredictable in its presentation and may require surgical intervention to obtain a contained and stable joint. Such patients are at a higher risk of developing degenerative hip disease in early adult life and can suffer considerable disability, often failing to reach their full potential. Thus, many initiatives have been taken to improve our current screening programs, including clinical education programs, streamlined access, and incorporation of hip examinations into child health assessments. However, none of these initiatives has effectively reduced the rate of late detection of dysplasia. Despite selective screening protocols being in place, the incidence of late-diagnosed DDH has increased in South Australia, showing a significant rise from 0.22 per 1000 live births (1988-2003) to 0.77 per 1000 live births (2003-2009).

One part of the solution is optimising screening protocols for DDH in existing care models. A possible solution is utilising artificial intelligence to aid in screening decisions. One such new tool is the Exo Iris, a portable ultrasound device supported by real-time AI-augmented analysis to screen for hip dysplasia. Importantly, use of this device does not require extensive training and could be performed by midwives or paediatricians in standard neonate hip examinations. Initial work has shown that AI could successfully identify the standard plane, make measurements, and classify the hip as normal or abnormal. Scans are simple to conduct, add little time to the overall consultation and are non-invasive without the use of ionising radiation. Importantly, non-experts can easily be trained to use the technology; they are cost-effective and can be used in any clinical environment connected to a standard tablet.

Initial Canadian data suggests that DDH detection rates suggests that artificial intelligence (AI) analysis for hip dysplasia are on par with orthopaedic specialists. Of the infants flagged for follow-up there were 6 subsequently referred to specialist clinics after repeat scan and all were treated for DDH (5 harnessed, 1 surgical intervention). Of these the six infants detected, only two presented with well documented risk factors for increased risk of DDH (female sex, Indigenous, breech, family history), which may not have been detected without initial portable ultrasound screening.

Further to this, Retuve is a new open-source software tool that uses AI-analysis to measures standard indices on hip ultrasound images collected from any manufacturer's ultrasound probe, which can help users make hip screening decisions. This platform generates novel imaging parameters beyond current standards that may also be helpful in further understanding undetected late presentations. However, as this is a relatively new tool there has been little research to fully evaluate its performance and its potential utility as a screening tool.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Enrolled in the Victorian Hip Dysplasia Registry (VicHip) study
  • Infant born at term (≥37 weeks gestation)
  • Infant and caregiver admitted to the post-natal ward
  • Caregivers indicate they are willing to attend a 6-week ultrasound
  • Caregivers can provide a signed and dated informed consent form and is a legally acceptable representative capable of understanding the informed consent document and providing consent on the infant's behalf.

排除标准

  • Any known congenital anomalies in the infant precluding examination of the hips
  • Any known congenital neuromuscular conditions in the infant

研究组 & 干预措施

All active participants

Experimental

All infants will undergo the AI-augmented ultrasound measure

干预措施: Artificial intelligence augmented ultrasound (Device)

结局指标

主要结局

Feasibility of the AI-ultrasound method as determined by a study-specific questionnaire administered to care givers at Day 1

时间窗: Day 1

Caregiver perspectives will be captured via a study-specific questionnaire administered at Day 1 and this will enable determination of the feasibility of the AI-ultrasound method.

Number of infants unable to be scanned with the AI ultrasound

时间窗: Day 1

The proportion of infants unable to be successfully scanned with the AI-ultrasound will be calculated.

Reasons for failure to obtain AI ultrasound scan as determined by the performing research assistant

时间窗: Day 1

The reasons why infants were unable to be scanned as determined by the research assistant performing the AI scan will be documented as follows: Unsettled baby, technical failure, body habitus or other.

Proportion of infants lost to follow-up between the AI-ultrasound and 6-week (corrected) diagnostic scan

时间窗: Week 6

The proportion of infants that had an initial AI scan at Day 1 but did not return for a scan at Week 6 will be calculated.

次要结局

  • Specificity of AI-ultrasound device as determined by comparison of the geometric measures (femoral head coverage and alpha angle) and expert reviews between the Day 1 and Week 6 scans(Day 1, Week 6)
  • Sensitivity of AI-ultrasound measure determined by comparison of the geometric measures (femoral head coverage and alpha angle) and expert reviews between the Day 1 and Week 6 scans(Day 1, Week 6)
  • The correlation between the alpha angle degree as reported by the AI-ultrasound analysis and expert analysis of the 6-week diagnostic ultrasound scan(Day 1, Week 6)
  • The correlation between the percentage femoral head coverage as reported by the AI-ultrasound analysis and expert analysis of the 6-week diagnostic ultrasound scan(Day 1, Week 6)

研究者

申办方类型
Other
责任方
Sponsor

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