Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]

BACKGROUND: The contribution of birth defects, including cleft lip and palate, to neonatal and infant mortality and morbidity is substantial. As other mortality and morbidity causes including infections, hygiene, prematurity, and nutrition are eradicated in less developed countries, the burden of birth defects will increase proportionally. METHODS/DESIGN: We are using cleft lip and palate as a sentinel birth defect to evaluate its burden on neonatal and infant health and to assess the effectiveness of systematic pediatric care during the first month and first two years of life in decreasing this burden. The neonatal intervention, consisting of weekly pediatric evaluation and referral to appropriate care, is delivered to about 696 infants born with cleft lip and/or palate in 47 hospitals in South America. Neonatal mortality in this group will be compared to that in a retrospective control group of about 464 infants born with cleft lip and/or palate in the same hospitals. The subgroup of infants with isolated clefts of both the lip and palate (about 264) is also randomized into two groups, intervened and non-intervened, and further followed up over 2 years. Intervened cases are evaluated by pediatricians every three months and referred for appropriate care. The intervened and non-intervened cases will be compared over study outcomes to evaluate the intervention effectiveness. Non-intervened cases are matched and compared to healthy controls to assess the burden of cleft lip and palate. Outcomes include child's neurological and physical development and family social and economic conditions. DISCUSSION: Large-scale clinical trials to improve infant health in developing countries are commonly suggested, making it important to share the methods used in ongoing studies with other investigators implementing similar research. We describe here the content of our ongoing pediatric care study in South America. We hope that this may help researchers targeting this area to plan their studies more effectively and encourage the development of similar research efforts to target other birth defects or infant outcomes such as prematurity and low birth weight

Speech therapy for compensatory articulations and velopharyngeal function: a case report

The objective of this study was to describe the process of intensive speech therapy for a 6-year-old child using compensatory articulations while presenting with velopharyngeal insufficiency (VPI) and a history of cleft lip and palate. The correction of VPI was temporarily done with a pharyngeal obturator since the child presented with very little movement of the pharyngeal walls during speech, compromising the outcome of a possible pharyngeal flap procedure (pharyngoplasty). The program of intensive speech therapy involved 3 phases, each for duration of 2 weeks incorporating 2 daily sessions of 50 minutes of therapy. A total of 60 sessions of intervention were done with the initial goal of eliminating the use of compensatory articulations. Evaluation before the program indicated the use of co-productions (coarticulations) of voiceless plosive and fricative sounds with glottal stops (simultaneous production of 2 places of productions), along with weak intraoral pressure and hypernasality, all compromising speech intelligibility. To address place of articulation, strategies to increase intraoral air pressure were used along with visual, auditory and tactile feedback, emphasizing the therapy target and the air pressure and airflow during plosive and fricative sound productions. After the first two phases of the program, oral place of articulation of the targets were achieved consistently. During the third phase, velopharyngeal closure during speech was systematically addressed using a bulb reduction program with the objective of achieving velopharyngeal closure during speech consistently. After the intensive speech therapy program involving the use of a pharyngeal obturator, we observed absence of hypernasality and compensatory articulation with improved speech intelligibility