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Timing of Primary Surgery for Cleft Palate
Sponsor: Kevin Munro
Summary
This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either: * Surgery at age 6 months, OR * Surgery at age 12 months. The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.
Key Details
Gender
All
Age Range
Any - 6 Months
Study Type
INTERVENTIONAL
Enrollment
558
Start Date
2010-07
Completion Date
2021-03-26
Last Updated
2026-09-02
Healthy Volunteers
No
Conditions
Interventions
primary surgery for cleft palate
Surgery completed using the Sommerlad technique
Locations (23)
University of Sao Paulo
Bauru, Brazil
Århus Speech and Hearing Institute
Aarhus, Denmark
Copenhagen Cleft Palate Centre
Copenhagen, Denmark
Helse Bergen HF
Bergen, Norway
Oslo University Hospital
Oslo, Norway
Göteborg University
Gothenburg, Sweden
University of Linköping
Linköping, Sweden
Malmö University Hospital
Malmö, Sweden
Karolinska University Hospital
Stockholm, Sweden
Umeå University
Umeå, Sweden
Uppsala University
Uppsala, Sweden
Belfast Health and Social Care Trust
Belfast, United Kingdom
Birmingham Children's NHS Foundation Trust
Birmingham, United Kingdom
North Bristol NHS Foundation Trust
Bristol, United Kingdom
Edinburgh Hospital for Sick Children
Edinburgh, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Leeds University Hospitals NHS foundation Trust
Leeds, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Newcastle University Hospitals NHs Foundation Trust
Newcastle, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Abertawe Bro Morgannwg University Health Board
Swansea, United Kingdom