<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03303755</url>
  </required_header>
  <id_info>
    <org_study_id>IS001087</org_study_id>
    <nct_id>NCT03303755</nct_id>
  </id_info>
  <brief_title>Predictive Models of Weight and Height for the Evaluation of the Growth of Children and Adolescents With Cerebral Palsy</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Council of Scientific and Technical Research, Argentina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Nacional de Córdoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Council of Scientific and Technical Research, Argentina</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cerebral palsy (CP) is the most frequent disability in children. The vast majority of these&#xD;
      patients are malnourished. In this population, there are practical difficulties to perform a&#xD;
      nutritional and growth assessment which makes it difficult to treat and follow up, because of&#xD;
      the lack of reference growth in Argentina, and the difficulty in taking anthropometric&#xD;
      measurements of weight and height because of their motor compromise, posture and muscle tone.&#xD;
&#xD;
      The main objective is to design and validate predictive models for the nutritional and growth&#xD;
      assessment of children and adolescents with CP and instruments for estimating weight and&#xD;
      height from body segments, in order to improve care, quality of life of these patients to&#xD;
      promote their social inclusion.&#xD;
&#xD;
      Material and method: It will be an observational, descriptive and cross-sectional study.&#xD;
      There will be two parts of the study, in the first part the population will be healthy&#xD;
      children from 2 to 18 years old from Cordoba, Argentina. The sample size was calculated based&#xD;
      on growth WHO standards data, for α=0.05 and 1-β=0.80, creating an stratified sampling&#xD;
      divided in 16 age groups for each age. This first part will help to establish which body&#xD;
      segments to use.&#xD;
&#xD;
      In the second part, the population will be children and adolescents from 2 to 18 years old&#xD;
      with diagnosis of CP from Córdoba, Argentina. A stratified sequential sampling shall be&#xD;
      performed. The sample size will be 192 patients, 12 per age stratum. The variables studied&#xD;
      will be: weight, height, body segments, sex, age, CP type, feeding path and type of feeding.&#xD;
&#xD;
      For the analysis of the data the normal continuous variables will be described in means with&#xD;
      their respective standard deviations and those of non-normal distribution in medians with&#xD;
      their ranges. For the development of the predictive equations using body segments measures, a&#xD;
      generalizable linear regression model will be used. The correlation coefficient r,&#xD;
      determination R2 and test of F will be calculated with p &lt;0.05. To generate predictive growth&#xD;
      models, the percentiles from 3 to 97 will be calculated, using the LMS method and a q-q&#xD;
      graph.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to design predictive models of weight and height, through predictive equations&#xD;
      using segmental measurements and to develop specific growth patterns, for the nutritional and&#xD;
      growth evaluation of children and adolescents with cerebral palsy from different provinces of&#xD;
      Argentina.&#xD;
&#xD;
      This research is a cross-sectional study, which consisted of two stages. First, data were&#xD;
      collected from children and adolescents aged 2 to 18 years with typical development from&#xD;
      which the anthropometric variables associated with weight and height were determined and then&#xD;
      used for the analysis of the population with CP. A stratified sampling was made with 17&#xD;
      strata according to age for each sex, pre-establishing a minimum of 20 children for each&#xD;
      stratum. Data were collected transversely in two hospitals and two schools in the City of&#xD;
      Córdoba until all strata were completed.&#xD;
&#xD;
      In a second stage, data is collected from children and adolescents diagnosed with CP between&#xD;
      the ages of 2 and 19 years. Data were included from 17 rehabilitation centers and therapeutic&#xD;
      educational centers in 5 provinces of the country (Córdoba, Buenos Aires (CABA), Jujuy,&#xD;
      Santiago del Estero and Catamarca). A sequential non-probabilistic sampling was made,&#xD;
      including all possible cases of each participating institution. The variables studied were&#xD;
      demographic variables, anthropometric measures, nutritional status, type of malnutrition and&#xD;
      in the case of the population with PC also variables such as data on access to health,&#xD;
      diagnosis, co-morbidities and feeding were included. Normal continuous variables were&#xD;
      described as mean and standard deviations, while those of non-normal distribution in medians&#xD;
      with their interquartile ranges. Variables are compared by means of t-test or Mann-Whitney as&#xD;
      appropriate. Categorical data are expressed in percentages with a 95% confidence interval&#xD;
      [95% CI]. To analyze association between variables, Chi square of Mantel-Haentzel was&#xD;
      calculated, and OR with its 95% CI. For the development of predictive equations, a&#xD;
      generalizable linear regression model will be used. The correlation coefficient r,&#xD;
      determination R2 and F test were calculated with a p &lt;0.05. Growth patterns were made using&#xD;
      the Generalized Additive Models for Location Scale and Shape (GAMLSS) method. Nutritional&#xD;
      status was assessed using the WHO Anthro Plus V1.0.4 program using the WHO standards (2007).&#xD;
      The approval of the local ethics committee was obtained and written informed consent was&#xD;
      obtained from the participants.&#xD;
&#xD;
      The study of nutrition in patients with PC is an emerging field, for which this work plan&#xD;
      seeks to develop methodologies that promote social inclusion by making substantial and&#xD;
      necessary contributions to improve the treatment of this pathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Weight in children</measure>
    <time_frame>2 year</time_frame>
    <description>weight in kilograms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height in children</measure>
    <time_frame>2 year</time_frame>
    <description>height in centimeters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated weight</measure>
    <time_frame>1 year</time_frame>
    <description>weight in kilograms using Mid Arm Circumference in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated height</measure>
    <time_frame>1 year</time_frame>
    <description>height in centimeters using Knee hell height in centimeters</description>
  </secondary_outcome>
  <enrollment type="Actual">388</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Growth</condition>
  <condition>Child</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The population of this study will be made up of children aged 2 to 18 years with a&#xD;
        diagnosis of PCs who attend public and private health institutions in Córdoba.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with diagnosis of cerebral palsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with endocrine or metabolic disorders, genetic diseases and other congenital&#xD;
             anomalies that affect or have affected their growth or nutritional status.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo Cuestas, PhD MD</last_name>
    <role>Study Director</role>
    <affiliation>Instituto de Investigaciones en Ciencias de la Salud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Investigaciones en Ciencias de la Salud, Argentina</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23798905</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21768315</PMID>
  </reference>
  <reference>
    <citation>Le 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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17355471</PMID>
  </reference>
  <reference>
    <citation>Vega-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.</citation>
    <PMID>22559790</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17060071</PMID>
  </reference>
  <reference>
    <citation>Kong 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.</citation>
    <PMID>16322142</PMID>
  </reference>
  <reference>
    <citation>Neela 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.</citation>
    <PMID>1808075</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Council of Scientific and Technical Research, Argentina</investigator_affiliation>
    <investigator_full_name>Eduardo Cuestas</investigator_full_name>
    <investigator_title>PhD Reasercher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>the research group is yet not decided to make individual participant data available, we wont to have a bigger data base to decide.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03303755
org study id: IS001087
nct id: NCT03303755
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Weight in children
time frame: 2 year
description: weight in kilograms
measure: Height in children
time frame: 2 year
description: height in centimeters
measure: Estimated weight
time frame: 1 year
description: weight in kilograms using Mid Arm Circumference in centimeters
measure: estimated height
time frame: 1 year
description: height in centimeters using Knee hell height in centimeters
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eduardo Cuestas, PhD MD
role: Study Director
affiliation: Instituto de Investigaciones en Ciencias de la Salud
facility: 
country: Argentina
citation: 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.
PMID: 23798905
citation: 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
citation: Le 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.
citation: 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
citation: Vega-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.
PMID: 22559790
citation: 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
citation: Kong 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.
PMID: 16322142
citation: Neela 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.
PMID: 1808075
responsible party type: Principal Investigator
investigator affiliation: National Council of Scientific and Technical Research, Argentina
investigator full name: Eduardo Cuestas
investigator title: PhD Reasercher
mesh term: Cerebral Palsy
sharing ipd: Undecided
ipd description: the research group is yet not decided to make individual participant data available, we wont to have a bigger data base to decide.