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
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

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
Email anthea.masarei@gosh-tr.nthames.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesAdded 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) studiedSpeech therapy
InterventionInfants 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 typeOther
Primary outcome measureAdded 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 measuresAdded 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 date01/01/2002
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participantsAdded 08/01/2009: 50
Key inclusion criteriaInfants 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 criteriaAdded 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 enrolment01/01/2002
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Speech and Language Therapy Department
London
WC1N 3JH
United Kingdom

Sponsor information

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Website http://www.action.org.uk/
ROR logo "ROR" https://ror.org/01wcqa315

Funders

Funder type

Charity

Action Medical Research (UK)
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2007 Yes No