| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN65859742 |
| Date ISRCTN assigned | 25/10/2000 |
| Local reference number(s) | G9312055 |
| Public title | Ultrasound imaging in the management of clinical neonatal hip instability - a randomised controlled trial |
| Scientific title |
|
| Acronym | The Hip Trial |
| Disease/condition/study domain | Neonatal hip instability |
| Study hypothesis | 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/12/1994 |
| Anticipated end date | 01/01/2001 |
| Status of trial | Completed |
| Target number of participants | 629 |
| Interventions | Ultrasound imaging to guide the decision about whether to initiate treatment for clinical hip instability in neonates/control |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Publications | Results:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12504396
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15613565
UK Hip Trial - Reply: Lancet, 2003; 361(9367):1476-1477 |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Prof Diana Elbourne |
| Contact details | Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
United Kingdom
WC1E 7HT |
| Contact telephone | +44 (0)20 7927 2629 |
| Contact fax | +44 (0)20 7637 2853 |
| Contact email | diana.elbourne@lshtm.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN65859742 |
| Date last extracted from ISRCTN register | 17/04/2008 |
