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An investigation of the effects of pre-surgical orthodontics (baby plates) on feeding and speech outcomes in children with cleft lip and/or palate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31348959
Enrollment
50
Registered
2001-03-01
Start date
2002-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speech therapy Oral Health Cleft lip

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.

Sponsors

Action Medical Research (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026