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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Randomised controlled trial
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

Participant type(s)	Patient
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

Speech and Language Therapy Department

London
WC1N 3JH
United Kingdom

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

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

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

Intention to publish date
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

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