|
ISRCTN
|
ISRCTN31348959
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
An investigation of the effects of pre-surgical orthodontics (baby plates) on feeding and speech outcomes in children with cleft lip and/or palate
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
SP3308
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Speech therapy
|
|
Participants - inclusion criteria
|
Infants born with an isolated cleft of the palate (soft palate and 2/3 of the hard palate) or complete unilateral cleft of the lip and palate and who are referred to the twin site cleft lip and palate centre of St Andrews Centre for Burns and Plastic Surgery and Great Ormond Street Hospital for Children NHS Trust
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/2002
|
|
Anticipated end date
|
31/12/2005
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Infants recruited are randomised to be managed with or without baby plates. Minimisation is used to ensure that groups are similar with respect to sex and birth order.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Action Medical Research (UK)
|
|
Trial website
|
|
|
Publications
|
2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17328643
|
|
Contact name
|
Ms
Anthea
Masarei
|
|
Address
|
Speech and Language Therapy Department
Great Ormond Street Hospital for Children NHS Trust
Great Ormond Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC1N 3JH
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7813 8110
|
|
Email
|
anthea.masarei@gosh-tr.nthames.nhs.uk
|
|
Sponsor
|
Action Medical Research (UK)
|
|
Address
|
Vincent House
|
|
City/town
|
Horsham West Sussex
|
|
Zip/Postcode
|
RH12 2DP
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1403 210406
|
|
Fax
|
+44 (0)1403 210541
|
|
Email
|
info@actionresearch.co.uk
|
|
Date applied
|
01/03/2001
|
|
Last edited
|
07/08/2008
|
|
Date ISRCTN assigned
|
01/03/2001
|
