Nutritional Care for infant with Cleft Lip and palate Pre Surgery - Trial PACTR202210885312976
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Study Focus
Sponsor & Location
Smile Train
Timeline & Enrollment
Early Phase 1
Oct 31, 2022
Jan 01, 1900
Summary
IInfants with unilateral cleft lip and palate (UCLP) experience feeding difficulties due to the defect (Alighieri, et al, 2015: Miller, 2011). The only way they can extract milk from the nipple is by mechanical movements of the lips, tongue, and mandible that push the nipple against the cleft palate. This often results in prolonged feeding times or inadequate food intake (Haque et al, 2015). All these can result in malnutrition and delayed surgical repair of the UCLP, which increases the resources expended in taking care of such patients. Moreover, when feeding is unsuccessful, both parent and child become frustrated, so it is crucial that good feeding is achieved as soon as possible. Cost-effectiveness analysis is the type of economic evaluation that is most often used for evaluating health care programmes (Wyers et al., 2010). The result of a cost-effectiveness analysis is expressed in the ratio between costs and effects. Controlled clinical trials are the best source for data on the efficacy of health care interventions. Such trials are considered to be a good instrument with which to perform a concurrent economic evaluation. When combining a clinical trial and an economic evaluation, efficacy as well as efficiency of an intervention can be analysed. The present study is based on the principles of cost-effectiveness analysis. The aim of this study is to compare 2 nutritional interventions and determine the cost-effectiveness for cleft lip and palate. Therefore, this trial will compare nutritional treatment in the first year of life between two groups.Objectives1. To determine the impact of nutritional interventions and compare the two groups among children with cleft lip palate2. To determine the cost-effectiveness of nutritional interventions among children with cleft lip palate
ICD-10 Classifications
Data Source
Pan Africa Clinical Trials Registry
PACTR202210885312976
Non-Device Trial

