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NOT YET RECRUITING
NCT06765525
NA

Efficacy Study of DeepDDH System in Screening Infants with Developmental Dysplasia of the Hip (DDH)

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

To ascertain the efficacy of the DeepDDH system, a deep learning framework, in enhancing diagnostic accuracy and curtailing follow-up intervals for infants undergoing screening for developmental dysplasia of the hip (DDH), the researchers are executing a blinded, randomized controlled trial. This trial juxtaposes AI-only and AI-assisted assessments of DDH against sonographer interpretations across various proficiency levels in the preliminary analysis of ultrasound images.

Official title: Blinded Randomized Control Trail of Artificial Intelligence-Assisted Ultrasound Screening for Neonatal Hip Dysplasia in a Clinical Cohort

Key Details

Gender

All

Age Range

28 Days - 6 Months

Study Type

INTERVENTIONAL

Enrollment

1976

Start Date

2025-01-15

Completion Date

2025-04-30

Last Updated

2025-01-09

Healthy Volunteers

No

Interventions

OTHER

Junior sonographer measurement of DDH

Participants will not receive visual cues from the DeepDDH system. Junior sonographer technicians will offer preliminary interpretations before these are subjected to validation and subsequent review by expert's team.

OTHER

Senior sonographer measurement of DDH

Participants will not receive visual cues from the DeepDDH system.

OTHER

Automated annotation of the DDH measurement through deep learning

Through randomization, a subset of the preliminary interpretations will be conducted by AI technology, and the study team will evaluate the degree of divergence between these AI-generated preliminary interpretations and the final interpretations.

OTHER

AI-assisted junior sonographer meaturement of DDH

Participants will receive visual cues from the DeepDDH system.

Locations (1)

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China