Ultrasound imaging in the management of clinical neonatal hip instability - a randomised controlled trial
ISRCTN | ISRCTN65859742 |
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DOI | https://doi.org/10.1186/ISRCTN65859742 |
Secondary identifying numbers | G9312055 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 15/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Diana Elbourne
Scientific
Scientific
Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
Phone | +44 (0)20 7927 2629 |
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diana.elbourne@lshtm.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Diagnostic |
Scientific title | |
Study acronym | The Hip Trial |
Study objectives | To assess the clinical effectiveness and cost effectiveness of a policy of ultrasound imaging to guide the decision about whether to initiate treatment for clinical hip instability in neonates. In particular the trial will assess whether the reduction in the use of splinting following ultrasound diagnosis is associated with an increased need for late treatment |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Neonatal hip instability |
Intervention | Ultrasound imaging to guide the decision about whether to initiate treatment for clinical hip instability in neonates/control. |
Intervention type | Other |
Primary outcome measure | X-ray appearance between 12 and 24 months used as a measure of hip function, proportion of babies splinted; proportion of babies needing surgery; financial burden on families and the health services; pyschosocial impact on families |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/12/1994 |
Completion date | 01/01/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 629 |
Key inclusion criteria | Babies less than 6 weeks old with a clinical suspicion of neonatal hip instability 1. Suspicion confirmed by a second doctor 2. There is clinical uncertainty about whether the decision to initiate treatment should be guided by ultrasound examination |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/12/1994 |
Date of final enrolment | 01/01/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medical Statistics Unit
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
Medical Research Council (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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clinical.trial@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK) (ref: G9312055)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/12/2002 | Yes | No | |
Results article | results | 01/01/2005 | Yes | No |