Cerebral PalsyNCT03303755
Predictive Models of Weight and Height for the Evaluation of the Growth of Children and Adolescents With Cerebral Palsy
An observational study of Cerebral Palsy and Growth, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
Trial summary
Cerebral palsy (CP) is the most frequent disability in children. The vast majority of these patients are malnourished. In this population, there are practical difficulties to perform a nutritional and growth assessment which makes it difficult to treat and follow up, because of the lack of reference growth in… Read more about this study
- Who is it for?
- Ages 2 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Growth, Child
- How many people
- 388 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Apr 2014to 1 Apr 2020
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The population of this study will be made up of children aged 2 to 18 years with a diagnosis of PCs who attend public and private health institutions in Córdoba.
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
About this study
Official title: Elaboration, Development and Validation of Predictive Models of Weight and Height for the Evaluation of the Growth of Children and Adolescents With Cerebral Palsy
Cerebral palsy (CP) is the most frequent disability in children. The vast majority of these patients are malnourished. In this population, there are practical difficulties to perform a nutritional and growth assessment which makes it difficult to treat and follow up, because of the lack of reference growth in Argentina, and the difficulty in taking anthropometric measurements of weight and height because of their motor compromise, posture and muscle tone.
The main objective is to design and validate predictive models for the nutritional and growth assessment of children and adolescents with CP and instruments for estimating weight and height from body segments, in order to improve care, quality of life of these patients to promote their social inclusion.
Read more
Material and method: It will be an observational, descriptive and cross-sectional study. There will be two parts of the study, in the first part the population will be healthy children from 2 to 18 years old from Cordoba, Argentina. The sample size was calculated based on growth WHO standards data, for α=0.05 and 1-β=0.80, creating an stratified sampling divided in 16 age groups for each age. This first part will help to establish which body segments to use.
In the second part, the population will be children and adolescents from 2 to 18 years old with diagnosis of CP from Córdoba, Argentina. A stratified sequential sampling shall be performed. The sample size will be 192 patients, 12 per age stratum. The variables studied will be: weight, height, body segments, sex, age, CP type, feeding path and type of feeding.
For the analysis of the data the normal continuous variables will be described in means with their respective standard deviations and those of non-normal distribution in medians with their ranges. For the development of the predictive equations using body segments measures, a generalizable linear regression model will be used. The correlation coefficient r, determination R2 and test of F will be calculated with p <0.05. To generate predictive growth models, the percentiles from 3 to 97 will be calculated, using the LMS method and a q-q graph.
Read the detailed description
The aim is to design predictive models of weight and height, through predictive equations using segmental measurements and to develop specific growth patterns, for the nutritional and growth evaluation of children and adolescents with cerebral palsy from different provinces of Argentina.
This research is a cross-sectional study, which consisted of two stages. First, data were collected from children and adolescents aged 2 to 18 years with typical development from which the anthropometric variables associated with weight and height were determined and then used for the analysis of the population with CP. A stratified sampling was made with 17 strata according to age for each sex, pre-establishing a minimum of 20 children for each stratum. Data were collected transversely in two hospitals and two schools in the City of Córdoba until all strata were completed.
In a second stage, data is collected from children and adolescents diagnosed with CP between the ages of 2 and 19 years. Data were included from 17 rehabilitation centers and therapeutic educational centers in 5 provinces of the country (Córdoba, Buenos Aires (CABA), Jujuy, Santiago del Estero and Catamarca). A sequential non-probabilistic sampling was made, including all possible cases of each participating institution. The variables studied were demographic variables, anthropometric measures, nutritional status, type of malnutrition and in the case of the population with PC also variables such as data on access to health, diagnosis, co-morbidities and feeding were included. Normal continuous variables were described as mean and standard deviations, while those of non-normal distribution in medians with their interquartile ranges. Variables are compared by means of t-test or Mann-Whitney as appropriate. Categorical data are expressed in percentages with a 95% confidence interval [95% CI]. To analyze association between variables, Chi square of Mantel-Haentzel was calculated, and OR with its 95% CI. For the development of predictive equations, a generalizable linear regression model will be used. The correlation coefficient r, determination R2 and F test were calculated with a p <0.05. Growth patterns were made using the Generalized Additive Models for Location Scale and Shape (GAMLSS) method. Nutritional status was assessed using the WHO Anthro Plus V1.0.4 program using the WHO standards (2007). The approval of the local ethics committee was obtained and written informed consent was obtained from the participants.
The study of nutrition in patients with PC is an emerging field, for which this work plan seeks to develop methodologies that promote social inclusion by making substantial and necessary contributions to improve the treatment of this pathology.
- Conditions
- Cerebral Palsy, Growth, Child
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in children
weight in kilograms
Measured: 2 year
Height in children
height in centimeters
Measured: 2 year
Secondary outcomes (2)
Estimated weight
weight in kilograms using Mid Arm Circumference in centimeters
Measured: 1 year
estimated height
height in centimeters using Knee hell height in centimeters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Apr 2014
- Primary completion1 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Collaborators
- Universidad Nacional de Córdoba
- Responsible party
- Principal investigator, Eduardo Cuestas, National Council of Scientific and Technical Research, Argentina
- Investigators
- Eduardo Cuestas, PhD MD, Study director, Instituto de Investigaciones en Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303755
- Sponsor's protocol ID
- IS001087
- Status last verified
- Mar 2021
- First submitted
- 14 Sep 2017
- 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
Abdel-Rahman SM, Ahlers N, Holmes A, Wright K, Harris A, Weigel J, Hill T, Baird K, Michaels M, Kearns GL. Validation of an improved pediatric weight estimation strategy. J Pediatr Pharmacol Ther. 2013 Apr;18(2):112-21. doi: 10.5863/1551-6776-18.2.112.
PubMed 23798905Brooks 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 21768315Le Roy O. C, Rebollo G. MJ, Moraga M. F, Díaz Sm. X, Castillo-Durán C. Nutrición del niño con enfermedades neurológicas prevalentes. Rev Chil Pediatr. 2010;81(2):103-113.
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 17355471Vega-Sanchez R, de la Luz Gomez-Aguilar M, Haua K, Rozada G. Weight-based nutritional diagnosis of Mexican children and adolescents with neuromotor disabilities. BMC Res Notes. 2012 Jul 4;5:218. doi: 10.1186/1756-0500-5-218.
PubMed 22559790Bell 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 17060071Kong CK, Wong HS. Weight-for-height values and limb anthropometric composition of tube-fed children with quadriplegic cerebral palsy. Pediatrics. 2005 Dec;116(6):e839-45. doi: 10.1542/peds.2005-1029.
PubMed 16322142Neela J, Raman L, Balakrishna N, Rao KV. Usefulness of calf circumference as a measure for screening low birth weight infants. Indian Pediatr. 1991 Aug;28(8):881-4.
PubMed 1808075
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration, Development and Validation of Predictive Models of Weight and Height for the Evaluation of the Growth of Children and Adolescents With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03303755
- Acronym / sponsor ID
- IS001087
- Conditions
- Cerebral Palsy, Growth, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Collaborators
- Universidad Nacional de Córdoba
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebral palsy (CP) is the most frequent disability in children. The vast majority of these patients are malnourished. In this population, there are practical difficulties to perform a nutritional and growth assessment which makes it difficult to treat and follow up, because of the lack of reference growth in Argentina, and the difficulty in taking anthropometric measurements of weight and height because of their motor compromise, posture and muscle tone.
The main objective is to design and validate predictive models for the nutritional and growth assessment of children and adolescents with CP and instruments for estimating weight and height from body segments, in order to improve care, quality of life of these patients to promote their social inclusion.
Material and method: It will be an observational, descriptive and cross-sectional study. There will be two parts of the study, in the first part the population will be healthy children from 2 to 18 years old from Cordoba, Argentina. The sample size was calculated based on growth WHO standards data, for α=0.05 and 1-β=0.80, creating an stratified sampling divided in 16 age groups for each age. This first part will help to establish which body segments to use.
In the second part, the population will be children and adolescents from 2 to 18 years old with diagnosis of CP from Córdoba, Argentina. A stratified sequential sampling shall be performed. The sample size will be 192 patients, 12 per age stratum. The variables studied will be: weight, height, body segments, sex, age, CP type, feeding path and type of feeding.
For the analysis of the data the normal continuous variables will be described in means with their respective standard deviations and those of non-normal distribution in medians with their ranges. For the development of the predictive equations using body segments measures, a generalizable linear regression model will be used. The correlation coefficient r, determination R2 and test of F will be calculated with p <0.05. To generate predictive growth models, the percentiles from 3 to 97 will be calculated, using the LMS method and a q-q graph.
Detailed description
The aim is to design predictive models of weight and height, through predictive equations using segmental measurements and to develop specific growth patterns, for the nutritional and growth evaluation of children and adolescents with cerebral palsy from different provinces of Argentina.
This research is a cross-sectional study, which consisted of two stages. First, data were collected from children and adolescents aged 2 to 18 years with typical development from which the anthropometric variables associated with weight and height were determined and then used for the analysis of the population with CP. A stratified sampling was made with 17 strata according to age for each sex, pre-establishing a minimum of 20 children for each stratum. Data were collected transversely in two hospitals and two schools in the City of Córdoba until all strata were completed.
In a second stage, data is collected from children and adolescents diagnosed with CP between the ages of 2 and 19 years. Data were included from 17 rehabilitation centers and therapeutic educational centers in 5 provinces of the country (Córdoba, Buenos Aires (CABA), Jujuy, Santiago del Estero and Catamarca). A sequential non-probabilistic sampling was made, including all possible cases of each participating institution. The variables studied were demographic variables, anthropometric measures, nutritional status, type of malnutrition and in the case of the population with PC also variables such as data on access to health, diagnosis, co-morbidities and feeding were included. Normal continuous variables were described as mean and standard deviations, while those of non-normal distribution in medians with their interquartile ranges. Variables are compared by means of t-test or Mann-Whitney as appropriate. Categorical data are expressed in percentages with a 95% confidence interval [95% CI]. To analyze association between variables, Chi square of Mantel-Haentzel was calculated, and OR with its 95% CI. For the development of predictive equations, a generalizable linear regression model will be used. The correlation coefficient r, determination R2 and F test were calculated with a p <0.05. Growth patterns were made using the Generalized Additive Models for Location Scale and Shape (GAMLSS) method. Nutritional status was assessed using the WHO Anthro Plus V1.0.4 program using the WHO standards (2007). The approval of the local ethics committee was obtained and written informed consent was obtained from the participants.
The study of nutrition in patients with PC is an emerging field, for which this work plan seeks to develop methodologies that promote social inclusion by making substantial and necessary contributions to improve the treatment of this pathology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The population of this study will be made up of children aged 2 to 18 years with a diagnosis of PCs who attend public and private health institutions in Córdoba.
Key inclusion criteria (1 listed)
- Children with diagnosis of cerebral palsy
Key exclusion criteria (1 listed)
- children with endocrine or metabolic disorders, genetic diseases and other congenital anomalies that affect or have affected their growth or nutritional status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight in children
Time frame: 2 year
weight in kilograms
Height in children
Time frame: 2 year
height in centimeters
2 secondary outcomes
Estimated weight
Time frame: 1 year
estimated height
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Background: PubMed 23798905Abdel-Rahman SM, Ahlers N, Holmes A, Wright K, Harris A, Weigel J, Hill T, Baird K, Michaels M, Kearns GL. Validation of an improved pediatric weight estimation strategy. J Pediatr Pharmacol Ther. 2013 Apr;18(2):112-21. doi: 10.5863/1551-6776-18.2.112.
- Background: PubMed 21768315Brooks 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.
- BackgroundLe Roy O. C, Rebollo G. MJ, Moraga M. F, Díaz Sm. X, Castillo-Durán C. Nutrición del niño con enfermedades neurológicas prevalentes. Rev Chil Pediatr. 2010;81(2):103-113.
- Background: PubMed 17355471Day 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.
- Background: PubMed 22559790Vega-Sanchez R, de la Luz Gomez-Aguilar M, Haua K, Rozada G. Weight-based nutritional diagnosis of Mexican children and adolescents with neuromotor disabilities. BMC Res Notes. 2012 Jul 4;5:218. doi: 10.1186/1756-0500-5-218.
- Background: PubMed 17060071Bell 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.
- Background: PubMed 16322142Kong CK, Wong HS. Weight-for-height values and limb anthropometric composition of tube-fed children with quadriplegic cerebral palsy. Pediatrics. 2005 Dec;116(6):e839-45. doi: 10.1542/peds.2005-1029.
- Background: PubMed 1808075Neela J, Raman L, Balakrishna N, Rao KV. Usefulness of calf circumference as a measure for screening low birth weight infants. Indian Pediatr. 1991 Aug;28(8):881-4.
- Individual participant dataSharing planned: Undecided. the research group is yet not decided to make individual participant data available, we wont to have a bigger data base to decide.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Cuestas, PhD MD study director
Instituto de Investigaciones en Ciencias de la Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Growth, 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight in children (time frame: 2 year). 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 NCT03303755, which also lists 8 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.