Ignite Creation Date:
2025-12-18 @ 10:00 AM
Ignite Modification Date:
2025-12-18 @ 10:00 AM
Study NCT ID:
NCT04179422
Status:
None
Last Update Posted:
2021-03-19 00:00:00
First Post:
2019-10-17 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Status and Family Strategies in Children With Cerebral Palsy.
Sponsor:
None
Organization:
Study Overview
Official Title:
Nutritional Status and Family Strategies Linked to Feeding in Children and Adolescents With Cerebral Palsy.
Status:
None
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research was an observational, descriptive, cross-sectional study. The population was made up of children and adolescents from 2 to 18 11 months years of age with CP diagnosis and their families who attended public and private health institutions in the City of Córdoba. A non-probability sequential sampling was carried out. The sample size was calculated for an expected prevalence of at least 25% of nutritional deficit in children and adolescents with CP to detect the strategies that predict good nutritional status with an odds ratio of at least 2 in 94 patients (Ortega Calvo and Cayuela Dominguez 2002) The families were invited to participate through the directors or managers of the educational centers or institutions. They were communicated orally and then in writing what the project was about.
This study included all children of both sexes from 2 to 18 years and 11 months with a diagnosis of CP defined as a disability that describes a group of permanent developmental disorders of movement and posture, which cause activity limitation, attributable to non-progressive alterations that occur in the developing fetal or infant brain. CP motor disorder is often accompanied by disturbances in sensation, perception, cognition, communication, and behavior; due to epilepsy and secondary musculoskeletal problems, who attend rehabilitation centers or public and private therapeutic educational centers in the city of Córdoba and neighboring towns that agree to participate and whose parents, guardians or caregivers sign the informed consent and want to participate. The CP diagnosis was taken from the Unique Certificate of Disability and in those children who were not established, the medical records were searched.
The normality of the continuous data was tested with the Kolmogorov-Smirnov test and they were reported as mean and standard deviations, while the non-normal distribution as medians with their interquartile ranges. Discrete data were expressed in absolute frequencies and percentages with 95% CI. The data that were non-parametric underwent a logarithmic transformation for their conversion to parametric.
The nutritional assessment, in accordance with the WHO reference parameters, was performed using the WHO Anthro Plus V1.0.4 anthropometric assessment program which uses the official WHO 2007 reference standards, providing accurate z-score values. Due to the fact that the growth patterns of the WHO (2007) do not present weight-for-age data up to 18 years of age, it was decided to use the Argentine references of the Argentine Society of Pediatrics, standardizing the weight by sex and age (2013).
Then a) Bivariate analysis will be carried out: The relationship between energy and macronutrient intake, factors related to food and nutritional assessment of children with CP, were analyzed using Chi-square tests with Fisher's test, t-test, or Mann-Whitney, as applicable. Variables that were significant with a p value \<0.05 were placed in a multivariate model. b) Multivariate analysis: A multiple logistic regression model was used to identify significant predictors for adequate caloric and macronutrient intake, adjusted for sex, age, and CP severity.
The study of nutrition in patients with CP is an emerging field that has not yet been developed in our country, for which this work plan seeks to develop methodologies that promote social inclusion by making substantial and necessary contributions to improve the treatment and quality of life of children and adolescents with CP.
This study included all children of both sexes from 2 to 18 years and 11 months with a diagnosis of CP defined as a disability that describes a group of permanent developmental disorders of movement and posture, which cause activity limitation, attributable to non-progressive alterations that occur in the developing fetal or infant brain. CP motor disorder is often accompanied by disturbances in sensation, perception, cognition, communication, and behavior; due to epilepsy and secondary musculoskeletal problems, who attend rehabilitation centers or public and private therapeutic educational centers in the city of Córdoba and neighboring towns that agree to participate and whose parents, guardians or caregivers sign the informed consent and want to participate. The CP diagnosis was taken from the Unique Certificate of Disability and in those children who were not established, the medical records were searched.
The normality of the continuous data was tested with the Kolmogorov-Smirnov test and they were reported as mean and standard deviations, while the non-normal distribution as medians with their interquartile ranges. Discrete data were expressed in absolute frequencies and percentages with 95% CI. The data that were non-parametric underwent a logarithmic transformation for their conversion to parametric.
The nutritional assessment, in accordance with the WHO reference parameters, was performed using the WHO Anthro Plus V1.0.4 anthropometric assessment program which uses the official WHO 2007 reference standards, providing accurate z-score values. Due to the fact that the growth patterns of the WHO (2007) do not present weight-for-age data up to 18 years of age, it was decided to use the Argentine references of the Argentine Society of Pediatrics, standardizing the weight by sex and age (2013).
Then a) Bivariate analysis will be carried out: The relationship between energy and macronutrient intake, factors related to food and nutritional assessment of children with CP, were analyzed using Chi-square tests with Fisher's test, t-test, or Mann-Whitney, as applicable. Variables that were significant with a p value \<0.05 were placed in a multivariate model. b) Multivariate analysis: A multiple logistic regression model was used to identify significant predictors for adequate caloric and macronutrient intake, adjusted for sex, age, and CP severity.
The study of nutrition in patients with CP is an emerging field that has not yet been developed in our country, for which this work plan seeks to develop methodologies that promote social inclusion by making substantial and necessary contributions to improve the treatment and quality of life of children and adolescents with CP.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: