Ultrasound imaging in the management of clinical neonatal hip instability - a randomised controlled trial

ISRCTN ISRCTN65859742
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

Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone +44 (0)20 7927 2629
Email diana.elbourne@lshtm.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific title
Study acronymThe Hip Trial
Study objectivesTo 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) studiedNeonatal hip instability
InterventionUltrasound imaging to guide the decision about whether to initiate treatment for clinical hip instability in neonates/control.
Intervention typeOther
Primary outcome measureX-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 measuresNot provided at time of registration
Overall study start date01/12/1994
Completion date01/01/2001

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants629
Key inclusion criteriaBabies 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 criteriaNot provided at time of registration
Date of first enrolment01/12/1994
Date of final enrolment01/01/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medical Statistics Unit
London
WC1E 7HT
United Kingdom

Sponsor information

Medical Research Council (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email 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
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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