|
ISRCTN
|
ISRCTN31348959
|
|
DOI
|
10.1186/ISRCTN31348959
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
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
|
Added 08/01/2009:
To investigate the controversial assertion that pre-surgical orthopedics (PSO) facilitate feeding in infants with cleft lip and palate.
|
|
Lay summary
|
|
|
Ethics approval
|
Added 07/01/2010:
The Ethics Committee of GOSH and the Institute of Child Health gave approval.
|
|
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
|
Added 07/01/2010:
1. Required cardiac surgery
2. Diagnosed at birth with neurological impairment and/or a syndrome known to adversely affect feeding and/or growth
|
|
Anticipated start date
|
01/01/2002
|
|
Anticipated end date
|
31/12/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Added 08/01/2009: 50
|
|
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)
|
Added 08/01/2009:
Measurements were made at 3 months of age (pre-surgery) and at 12 months of age (post-surgery):
1. Anthropometry
2. Oral motor skills
|
|
Secondary outcome measure(s)
|
Added 08/01/2009:
1. Objective measures of sucking, collected at 3 months using the Great Ormond Street Measure of Infant Feeding
2. Videofluoroscopic assessment (in 21 participants only)
|
|
Sources of funding
|
Action Medical Research (UK)
|
|
Trial website
|
|
|
Publications
|
2007 results in 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 210 406
|
|
Fax
|
+44 (0)1403 210 541
|
|
Email
|
info@actionresearch.co.uk
|
|
Sponsor website:
|
http://www.action.org.uk/
|
|
Date applied
|
01/03/2001
|
|
Last edited
|
07/01/2010
|
|
Date ISRCTN assigned
|
01/03/2001
|
