An investigation of the effects of pre-surgical orthodontics (baby plates) on feeding and speech outcomes in children with cleft lip and/or palate
ISRCTN | ISRCTN31348959 |
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DOI | https://doi.org/10.1186/ISRCTN31348959 |
Secondary identifying numbers | SP3308 |
- Submission date
- 01/03/2001
- Registration date
- 01/03/2001
- Last edited
- 07/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Anthea Masarei
Scientific
Scientific
Speech and Language Therapy Department
Great Ormond Street Hospital for Children NHS Trust
Great Ormond Street
London
WC1N 3JH
United Kingdom
Phone | +44 (0)20 7813 8110 |
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anthea.masarei@gosh-tr.nthames.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Added 07/01/2010: The Ethics Committee of GOSH and the Institute of Child Health gave approval. |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/01/2002 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | Added 08/01/2009: 50 |
Key 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 |
Key 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 |
Date of first enrolment | 01/01/2002 |
Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Speech and Language Therapy Department
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Sponsor information
Action Medical Research (UK)
Charity
Charity
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Website | http://www.action.org.uk/ |
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https://ror.org/01wcqa315 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/03/2007 | Yes | No |