DESCRIPTION (provided by applicant): The application's long-term objective is to improve the surgical care of infants with clefts of the palate. These are congenital anomalies affecting around 1:1800 live births. There is uncertainty about the optimal timing and technique of surgical care and many affected individuals have post-surgical speech and hearing difficulties and secondary abnormalities of dental development. Remedial therapy may be demanding and expensive. Data from multi-centered randomised trials are required to inform decisions about surgery but as yet, there has been little progress in this area, due to the relative scarcity of cases, the fragmented nature of services and absence of a collaborative research culture and infrastructure. The specific aim of this "trial planning" application is to define a manual of operations and procedures for a set of multicentre trials of surgery for infants with isolated cleft palate. Completion of the manual will involve a number of meetings and consultations with experts in the field, led by an established group of researchers who are currently performing a similar group of trials of surgery for unilateral clefts.