Contact information
Type
Scientific
Primary contact
Ms Anthea Masarei
ORCID ID
Contact details
Speech and Language Therapy Department
Great Ormond Street Hospital for Children NHS Trust
Great Ormond Street
London
WC1N 3JH
United Kingdom
+44 (0)20 7813 8110
anthea.masarei@gosh-tr.nthames.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SP3308
Study information
Scientific title
Acronym
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.
Ethics approval
Added 07/01/2010:
The Ethics Committee of GOSH and the Institute of Child Health gave approval.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Speech therapy
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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)
Overall trial start date
01/01/2002
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Added 08/01/2009: 50
Participant 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
Recruitment start date
01/01/2002
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Speech and Language Therapy Department
London
WC1N 3JH
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17328643
Publication citations
-
Results
Masarei AG, Wade A, Mars M, Sommerlad BC, Sell D, A randomized control trial investigating the effect of presurgical orthopedics on feeding in infants with cleft lip and/or palate., Cleft Palate Craniofac. J., 2007, 44, 2, 182-193, doi: 10.1597/05-184.1.