Babies born with a cleft of the lip/cleft palate (CL/P) have an obvious facial disability. Surgeons perform an initial or primary repair of the lip and nose soon after birth. Unfortunately, the effects of the initial surgeries on the facial soft tissue form and/or movement are highly variable. Many patients are dissatisfied and remain with a facial disfigurement and impairment in facial soft tissue movements, and require multiple surgeries to improve the initial results. The decision to perform additional revision surgeries is based on a subjective assessment of the lips and nose made by the surgeon (in conjunction with the patient/parents). We have developed a novel set of static and dynamic quantitative and objective methods and measures to assess the facial soft tissue outcomes of movement (impairment) and form (disfigurement). These approaches were developed under the auspices of NIH grants DE 013814, DE 016964, and DE 013813-08S1. Thus, the goal of this R34 planning grant application is to set the stage for a future randomized clinical trial to evaluate whether the use of the dynamic and static quantitative measures by surgeons improves the facial soft tissue surgical outcomes of patients beyond that achieved by using the current subjective assessments only.
The Specific Aims of this planning grant are as follows.
Specific Aim 1. To assess the recruitment potential of each craniofacial center.
Specific Aim 2. To refine (1) the methodology and objective measures to assess facial impairment / disfigurement and the development of oromotor speech skills in babies with CL/P;(2) the protocol for training surgeons in the use of the objective measure;and (3) the psychosocial and cost measures for use in the study population.
Specific Aim 3. To develop a Manual of Procedures (MOP), that will include, but is not limited to, the development of consent form(s) and assent form(s), training materials and plans for surgeons and study staff, and a site quality management plan. We anticipate that the incorporation of the quantitative assessments will have a demonstrated sustainable impact on craniofacial care by improving the outcomes of surgical treatment and limiting the burden of repeated surgical interventions in CL/P children, their parents, and the health community.
Orofacial clefts affect approximately 6,800 births in the United States each year with an estimated 80% affected with a non-syndromic, sporadic unilateral or bilateral cleft lip and/or palate. Although children born with unilateral or bilateral cleft lip and palate benefit from primary lip repair, the majority of children will undergo subsequent lip revision surgeries because of dissatisfaction or residual impairment / disfigurement. During the past decade, our investigative team including surgeons responsible for the care of CL/P children have developed an objective quantitative assessment method that incorporates static and dynamic movements. This planning grant will provide the structure for a multi-center two-group parallel randomized clinical trial to compare the outcomes of treatment when surgeons use the innovative assessment measures and when they do not. This planning grant represents the first step in achieving our overall goal of improving the outcomes for a child born with a unilateral or bilateral non- syndromic complete cleft lip and palate.
