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Nutritional Care for infant with Cleft Lip and palate Pre Surgery - Trial PACTR202210885312976

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PACTR202210885312976
Early Phase 1
Recruiting
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202210885312976
Pure Global
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Nutritional Care for infant with Cleft Lip and palate Pre Surgery
Impact and cost-effectiveness of pre-surgical nutritional intervention in cleft palate surgical treatment

Study Focus

Oral Health

Sponsor & Location

Smile Train

Nigeria

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

Diseases of oral cavity, salivary glands and jaws
Dry mouth, unspecified
Oral mucositis (ulcerative)
Leukoplakia and other disturbances of oral epithelium, including tongue
Teething syndrome

Data Source

Pan Africa Clinical Trials Registry

PACTR202210885312976

Non-Device Trial