SHINE-2: Screening the hips in newborns. The use of an acoustic device to identify developmental hip dysplasia in babies
| ISRCTN | ISRCTN10735430 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10735430 |
| IRAS number | 324933 |
| Secondary identifying numbers | UoL001742, IRAS 324933, CPMS 56359 |
- Submission date
- 20/08/2024
- Registration date
- 22/08/2024
- Last edited
- 10/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Developmental dysplasia of the hip (DDH) is a condition that affects the hip joint in babies. In severe cases, the hip can be dislocated, and in milder cases, the hip may not develop properly. DDH is a common cause of hip problems later in life, including osteoarthritis, and can lead to hip replacements, especially in people under 60. Early diagnosis is crucial for effective treatment, which may involve a simple splint if caught early in infancy.
In the UK, DDH is currently screened through a combination of physical examinations and selective ultrasound scans. However, physical exams are not always accurate, and as a result, about two out of three hip dislocations might be missed. An alternative method used in some European countries involves screening all babies with ultrasound, but this approach is expensive and often gives false positives.
The SHINE2 study aims to improve how we screen for DDH by developing a new tool that uses sound to detect hip problems in infants. The goal is to create a simple, safe, and cost-effective screening method that can be easily used by healthcare professionals with minimal training.
Who can participate?
Babies under 3 months old who are already scheduled for hip screening as part of the national screening program can participate in this study.
What does the study involve?
For babies participating in the study, the researchers will use the new sound-based screening tool in addition to the standard screening methods. This will help refine the tool and assess its effectiveness. The process is non-invasive and should not cause any discomfort to the babies.
What are the possible benefits and risks of participating?
There is no direct benefit to research participants however patients often welcome participating in a study that could benefit others with the same condition.
The safety of participants, parents and staff is of paramount importance. Prior to use, electrical safety will be assured with an electronic Portable Appliance Test (‘PAT-test’). The sounds used will be well within the recommended safety thresholds for new born babies, which advise 1) the hourly Leq should not exceed 50 dB; 2) the hourly L should not exceed 55 dB; 3) the 1 s Lmax should not exceed 70 dB. The vibration experienced will be akin to placing a headphone playing music against the infant’s skin, with another headphone a specified distance away also against the skin listening for the sound transmitted. As far as possible, the device has been assembled from commercially available units, which have individually been certified by their manufacturers for sale. It comprises a USB-audio interface, an amplifier and associated wiring, running from a 240v mains supply. All the units are housed in a protective case rated to IP67, which provides an extra means of operator protection and prevents access to any of the internal units. The device is controlled by a standard Windows PC connected via USB. There are two attached parts which come into contact with the patient: the emitter and the detector. Both are housed in plastic enclosures which do not allow contact with internal components. The detector is purely passive. The emitter contains a commercial bone transducer which is powered by the amplifier. The amplifier can supply a maximum of 1.5A/12V. It generates a signal in the audible range 20-20000Hz. Sound level measurements have not been conducted but the audio volume is low in practice. We will carry out in-house electrical safety testing to EN 60601-1 1 “Medical electrical equipment — Part 1: General requirements for basic safety and essential performance”.
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
August 2023 to August 2025
Who is funding the study?
The study is funded by the University of Liverpool and Alder Hey Children's NHS Foundation Trust (UK)
Who is the main contact?
Professor Daniel Perry, danperry@liverpool.ac.uk.
Contact information
Public, Scientific, Principal Investigator
University of Liverpool, Institute of translational Medicine, 4th Floor, Alder Hey Children's NHS FT
Liverpool
L12 2AP
United Kingdom
 ORCID ID |
0000-0001-8420-8252 |
|---|---|
| danperry@liverpool.ac.uk |
Study information
| Study design | Basic Science involving procedures with human participants |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 45974 SHINE_PIS_v2.0_14.06.2023.pdf |
| Scientific title | SHINE-2: Screening the Hips in Newborns. The use of an acoustic device to identify developmental hip dysplasia in babies |
| Study acronym | SHINE-2 |
| Study objectives | Using developments in sensor technologies, we have experimented with acoustic sensors and sound transmission across joints. Through our previous project SHINE, we worked in the laboratory to develop the concept and refine the optimal means of sound transmission and detection though bone, along with optimal sound frequency (TRL1/2). We then developed a poof-of-concept device that could identify gaps within bone continuity (TRL3). We then worked on this proof-of-concept in the laboratory and in the hospital environment; where we tested in on the hips of 150 babies. Through this, we were able to make refinements to the device, clarify the optimal means of device application and the optimal position of the baby. We were able to demonstrate signals of effectiveness. However, the proof-of-concept has challenges to overcome, which include: • Ensuring the device can be used by a single clinical user. • Interpreting the signal to a meaningful output for the user |
| Ethics approval(s) |
Approved 26/06/2023, Health and Social Care Research Ethics Committee A (HSC REC A) (Business Services Organisation, Unit 4, Lissue Industrial Estate West, Rathdown Walk, Lisburn, BT28 2RF, United Kingdom; +44 28 9536 1400; RECA@hscni.net), ref: 23/NI/0066 |
| Health condition(s) or problem(s) studied | Developmental dysplasia of the hip (DDH) |
| Intervention | The assessment will involve an additional examination during routine ultrasound, which is being undertaken as part of the national selective screening program. In addition to the ultrasound examination, the child will have the prototype device applied (i.e. an external excitatory acoustic signal will be generated from an acoustic device that is placed on the knee. An external microphone will ‘listen’ and interpret the transmission of the acoustic signal across the hip, and any echoed back to the knee. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | SHINE sensor - A novel device to enhance the detection of developmental dysplasia of the hip (DDH) in babies through specific audible tones and/or the transmission of vibration across the hip joint. |
| Primary outcome measure | The sensitivity and specificity of the acoustic tool in the detection of DDH of the hip. The assessment will involve an additional examination during routine ultrasound, which being is undertaken as part of the national selective screening program. In addition to the ultrasound examination, the child will have the prototype device applied (i.e. an external excitatory acoustic signal will be generated from an acoustic device that is placed on the knee. An external microphone will ‘listen’ and interpret the transmission of the acoustic signal across the hip, and any echoed back to the knee). |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 17/08/2023 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Months |
| Upper age limit | 3 Months |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | Male and females under 3 months old meeting the criteria for hip screening as part of the national screening program |
| Key exclusion criteria | Children with joint contractures preventing normal body positioning during the routine neonatal examination (i.e. knee dislocation, arthrogryposis etc). |
| Date of first enrolment | 05/10/2023 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool
L14 5AB
United Kingdom
Sponsor information
University/education
4th Floor Thompson Yates Building, Faculty of Health and Life Sciences
University of Liverpool
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 7717863747 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Liverpool, 利物浦大学, Universidad de Liverpool, UoL
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Alder Hey Children's Hospital NHS Foundation Trust, Alder Hey Children's Hospital
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Material for dissemination will be developed in conjunction with the patient panel, the NIHR CRN: Children ‘Young Peoples Advisory Group’ and STEPS Worldwide. STEPS have agreed to communicate the outcomes of the research via their newsletter, website and information packages. For the wider public it is planned that the INVOLVE national advisory group will be an important liaison throughout, with dissemination adhering to the ‘make it clear’ guidance |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as no suitable register exists. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 14/06/2023 | 21/08/2024 | No | Yes |
| Protocol file | version 1.0 | 13/03/2023 | 21/08/2024 | No | No |
Additional files
Editorial Notes
10/09/2024: Internal review.
20/08/2024: Trial's existence confirmed by Health and Social Care Research Ethics Committee A (HSC REC A).
