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Improving Neonatal Hip Screening With Artificial Intelligence

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07794644
Enrollment
100
Registered
2026-08-31
Start date
2026-08-01
Completion date
2027-03-01
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Dysplasia of Hip

Keywords

hip dysplasia, artificial intelligence, screening, ultrasound, infant

Brief summary

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

Detailed description

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that 55.6% of cases of DDH were missed, and of those sent for diagnostic ultrasound scans 92.5% did not have DDH (unpublished data).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. There is clear scope for this technology to revolutionise screening in Australia by reducing the number of cases of DDH missed and the number of costly conventional ultrasound scans; however, there is limited data assessing the feasibility and accuracy of the new AI analysis strategies for DDH screening in the context of neonatal screening. To date, although the Exo Iris and embedded hip AI software is indicated for use in infants 0-6 months there is a dearth of data examining neonates, and no data exists evaluating it in the context of selective neonatal screening. This study will provide foundational pilot evidence on the accuracy and feasibility of using the Exo Iris probe and an alternate AI software platform as part of standard neonatal screening. In addition to this, long-term follow-up as part of the VicHip parent study will aid in understanding potential parameters associated with missed presentations. To do this, 100 infants will be recruited from Monash Medical Centre, Victoria, Australia and will undergo both the AI-ultrasound scan that will be analysed both by the embedded software and Retuve and results from the AI analyses will be compared to a 6-week full diagnostic ultrasound.

Interventions

The hip ultrasound is performed using a handheld device (Exo Iris) that is a pocket-sized ultrasound probe and is run through an application on an IoS (Apple mobile) operation system. A real-time algorithm detects and records the anatomical landmarks.

Sponsors

Murdoch Childrens Research Institute
Lead SponsorOTHER
Monash Health
CollaboratorOTHER
University of Alberta
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

All enrolled infants will be assigned to the intervention in addition to standard care.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Enrolled in the Victorian Hip Dysplasia Registry (VicHip) study 2. Infant born at term (≥37 weeks gestation) 3. Infant and caregiver admitted to the post-natal ward 4. Caregivers indicate they are willing to attend a 6-week ultrasound 5. 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.

Exclusion criteria

1. Any known congenital anomalies in the infant precluding examination of the hips 2. Any known congenital neuromuscular conditions in the infant

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the AI-ultrasound method as determined by a study-specific questionnaire administered to care givers at Day 1Day 1Caregiver 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 ultrasoundDay 1The 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 assistantDay 1The 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 scanWeek 6The 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.

Secondary

MeasureTime frameDescription
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 scansDay 1, Week 6AI-ultrasound results will be compared to 6-week diagnostic ultrasound imaging to calculate specificity (\[number of true negative cases detected/(number of false positive cases detected + number of true negatives cases detected\] X 100). Hips will be classified according to the AI-recommendations, "unremarkable" i.e. no follow-up required or "follow-up recommended" to define negative and positive cases; those that receive an "unremarkable" classification will be defined as negative cases, and those that receive a "follow-up recommended" scan will be considered as positive cases for the reliability calculations. Diagnosis will be defined from the 6-week ultrasound scan and will be defined by both expert conclusion and geometric measures (femoral head coverage and alpha angle). Calculations will be performed at both the hip and individual level.
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 scansDay 1, Week 6AI-ultrasound results will be compared to 6-week diagnostic ultrasound imaging to calculate sensitivity (\[number of true positive cases detected/(number of true positive cases detected + number of false negative cases detected)\] X 100). Hips will be classified according to the AI-recommendations, "unremarkable" i.e. no follow-up required or "follow-up recommended" to define negative and positive cases; those that receive an "unremarkable" classification will be defined as negative cases, and those that receive a "follow-up recommended" scan will be considered as positive cases for the reliability calculations. Diagnosis will be defined from the 6-week ultrasound scan and will be defined by both expert conclusion and geometric measures (femoral head coverage and alpha angle). Calculations will be performed at both the hip and individual level.
The correlation between the alpha angle degree as reported by the AI-ultrasound analysis and expert analysis of the 6-week diagnostic ultrasound scanDay 1, Week 6Dependent on the distribution of the data Pearsons or Spearman's Rho correlation coefficients will be reported.
The correlation between the percentage femoral head coverage as reported by the AI-ultrasound analysis and expert analysis of the 6-week diagnostic ultrasound scanDay 1, Week 6Dependent on the distribution of the data Pearsons or Spearman's Rho correlation coefficients will be reported.

Contacts

CONTACTBrian Loh
brian.loh@rch.org.au+61383416200
CONTACTNatalie Hyde
natalie.hyde@mcri.edu.au+61383416200
PRINCIPAL_INVESTIGATORBrian Loh, MBBS BBiomedSc FRACS FAOrthoA

Murdoch Children's Research Institute & Monash Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026