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Cerebral PalsyNCT04179422

Nutritional Status and Family Strategies in Children With Cerebral Palsy.

An observational study of Cerebral Palsy and Nutrition Disorders, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Cerebral Palsy, Nutrition Disorders, Child
What is being tested?
anthropometric measurement and nutritional questionnaire
How many people
100 participants
Where
1 siteArgentina
Study dates
1 Mar 2019to 30 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • Children with diagnosis of cerebral palsy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Argentina1 site
  • Instituto de Investigaciones en Ciencias de la Salud, Argentina

    Córdoba, 5000

Other trials in Argentina

About this study

Official title: Nutritional Status and Family Strategies Linked to Feeding in Children and Adolescents With Cerebral Palsy.

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.

Read the detailed description

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.

Being tested
anthropometric measurement, nutritional questionnaire
Medical subject headings
Cerebral Palsy, Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anthropometric measurementOther

    weight, height, BMI

  • nutritional questionnaireOther

    24hs food recall, presence of feeding disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutritional status

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

    Measured: 2 years

  2. feeding disorders

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start1 Mar 2019
  3. Primary completion1 Mar 2021
  4. Study completion30 Oct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04179422
Sponsor's protocol ID
IS002377
Status last verified
Mar 2021
First submitted
17 Oct 2019
Last updated
19 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: the research group is yet not decided to make individual participant data available, we wont to have a bigger data base to decide.

Publications

  • 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.

    PubMed 17355471
  • 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.

    PubMed 17060071
  • 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.

    PubMed 21768315

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy and Nutrition Disorders, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional status (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04179422, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.

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