Nutritional Status and Family Strategies in Children With Cerebral Palsy.

NCT04179422 | Unknown

• 1 other identifier: IS002377
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Nutrition Disorders; Child

Outcome Measures

Primary Outcomes (2)

• Nutritional status

  Weigth (Kg), height (cm), BMI (Kg/cm2)

  2 years

• feeding disorders

  Questionnaire: number of participants with dysphagia, number of participants with sialorrhea, number of participants with constipation, number of participants with gastroesophageal reflux

  2 years

Interventions

anthropometric measurement OTHER

weight, height, BMI

nutritional questionnaire OTHER

24hs food recall, presence of feeding disorders

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population of this study will be made up of children aged 2 to 18 years with a diagnosis of CP who attend public and private health institutions in Argentina.

You may qualify if:

• Children with diagnosis of cerebral palsy

You may not qualify if:

• children with endocrine or metabolic disorders, genetic diseases and other congenital anomalies that affect or have affected their growth or nutritional status.

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina: lead

Study Sites (1)

Instituto de Investigaciones en Ciencias de la Salud, Argentina

Córdoba, 5000, Argentina

Location

Related Publications (3)

• Day SM, Strauss DJ, Vachon PJ, Rosenbloom L, Shavelle RM, Wu YW. Growth patterns in a population of children and adolescents with cerebral palsy. Dev Med Child Neurol. 2007 Mar;49(3):167-71. doi: 10.1111/j.1469-8749.2007.00167.x.

  PMID: 17355471 BACKGROUND

• Bell KL, Davies PS. Prediction of height from knee height in children with cerebral palsy and non-disabled children. Ann Hum Biol. 2006 Jul-Aug;33(4):493-9. doi: 10.1080/03014460600814028.

  PMID: 17060071 BACKGROUND

• Brooks J, Day S, Shavelle R, Strauss D. Low weight, morbidity, and mortality in children with cerebral palsy: new clinical growth charts. Pediatrics. 2011 Aug;128(2):e299-307. doi: 10.1542/peds.2010-2801. Epub 2011 Jul 18.

  PMID: 21768315 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Nutrition Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eduardo Cuestas, PhD MD

  Instituto de Investigaciones en Ciencias de la Salud

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: November 27, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: October 30, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

AR (1)