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NCT04179422
Nutritional Status and Family Strategies in Children With Cerebral Palsy.
trial testing anthropometric measurement in Cerebral Palsy in 100 participants. Status unknown.
1 March 2021
Quick facts
| Lead sponsor | National Council of Scientific and Technical Research, Argentina |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 March 2019 |
| Primary completion | 1 March 2021 |
| Estimated completion | 30 October 2022 |
| Sites | 1 location across Argentina |
Drugs / interventions tested
- anthropometric measurement
- nutritional questionnaire
Conditions studied
- Cerebral Palsy — all drugs for Cerebral Palsy →
- Nutrition Disorders — all drugs for Nutrition Disorders →
- Child — all drugs for Child →
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.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04179422 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Council of Scientific and Technical Research, Argentina
- Last refreshed: 19 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04179422.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing