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NCT04179422

Nutritional Status and Family Strategies in Children With Cerebral Palsy.

Status unknown Last updated 19 March 2021
What this trial tests

trial testing anthropometric measurement in Cerebral Palsy in 100 participants. Status unknown.

Timeline
1 March 2019
Primary endpoint
1 March 2021
30 October 2022

Quick facts

Lead sponsorNational Council of Scientific and Technical Research, Argentina
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date1 March 2019
Primary completion1 March 2021
Estimated completion30 October 2022
Sites1 location across Argentina

Drugs / interventions tested

Conditions studied

Sponsor

National Council of Scientific and Technical Research, Argentina

Who can join

Adults 2 to 18, any sex, with Cerebral Palsy or Nutrition Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cerebral palsy (CP) is one of the neurological disorders that most often generates disability in pediatric age. Children with CP have a very high nutritional risk since their motor dysfunction causes coordination dysfunction in the processes of sucking, chewing and swallowing, which lead to insufficient intake. There are other difficulties in relation to feeding, such as the time required for feeding and the presence of gastrointestinal disorders. In addition, the families of children with CP develop different strategies that allow them to face reality. This research plan seeks to investigate the relationships between the nutritional status of children and adolescents with CP, food intake and family behavior according to the strategies they develop. This study will be observational, cross-sectional descriptive. The population will consist of children and adolescents from 2 to 18 years 11 months with a diagnosis of CP and their families attending health institutions in Córdoba. The minimum sample size in 187 subjects was calculated for an expected prevalence of 25% of feeding difficulties for an alpha 0.05 and a beta 0.20. It will be a successive sampling, until the desired sample is completed. The variables studied will be: age, weight, height, nutritional status, sex, type of CP, caloric and macro nutrient intake, type and feeding time, clinical difficulties related to feeding and family strategies For data analysis, normal continuous variables will be described in means with their standard deviations, with non-normal distribution in medians with their interquartile ranges. The daily food intake and macro nutrients will be calculated using the Food Analysis and Registration System software (SARA1.2.25). The relationship between the average energy intake, the nutritional status of children with CP and family strategies will be described. Interpretation of the data will be carried out, showing the relationship between the different areas, analyzing the connectivity of the ideas with the nutritional status.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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