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

ISRCTN	ISRCTN65859742
DOI	https://doi.org/10.1186/ISRCTN65859742
Protocol serial number	G9312055
Sponsor	Medical Research Council (UK)
Funder	Medical Research Council (UK) (ref: G9312055)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2001

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Medical Statistics Unit

London
WC1E 7HT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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