Condition category
Neonatal Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
15/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Diana Elbourne

ORCID ID

Contact details

Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2629
diana.elbourne@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9312055

Study information

Scientific title

Acronym

The Hip Trial

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/1994

Overall trial end date

01/01/2001

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

629

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/1994

Recruitment end date

01/01/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Statistics Unit
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) (ref: G9312055)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12504396
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15613565

Publication citations

  1. Results

    Gardner F, Dezateux C, Elbourne D, Gray A, King A, Quinn A, , The hip trial: psychosocial consequences for mothers of using ultrasound to manage infants with developmental hip dysplasia., Arch. Dis. Child. Fetal Neonatal Ed., 2005, 90, 1, F17-24, doi: 10.1136/adc.2002.025684.

  2. Elbourne D, Dezateux C, Arthur R, Clarke NM, Gray A, King A, Quinn A, Gardner F, Russell G, , Ultrasonography in the diagnosis and management of developmental hip dysplasia (UK Hip Trial): clinical and economic results of a multicentre randomised controlled trial., Lancet, 360, 9350, 2009-2017.

Additional files

Editorial Notes