Predictive Models of Weight and Height for the Evaluation of the Growth of Children and Adolescents With Cerebral Palsy

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303755
• Other study ID #: IS001087
• Status: Completed
• Start date: April 1, 2014
• Est. completion date: April 1, 2020

Study information

• Verified date: March 2021
• Source: National Council of Scientific and Technical Research, Argentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: April 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 19 Years

Eligibility

Inclusion Criteria:

• Children with diagnosis of cerebral palsy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Child
• Growth

Locations

Country	Name	City	State
Argentina	Instituto de Investigaciones en Ciencias de la Salud, Argentina	Cordoba

Sponsors (2)

Lead Sponsor	Collaborator
National Council of Scientific and Technical Research, Argentina	Universidad Nacional de Córdoba

Country where clinical trial is conducted

Argentina, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in children	weight in kilograms	2 year
Primary	Height in children	height in centimeters	2 year
Secondary	Estimated weight	weight in kilograms using Mid Arm Circumference in centimeters	1 year
Secondary	estimated height	height in centimeters using Knee hell height in centimeters	1 year

External Links

•   Rosenbaum P, Paneth N, Leviton A, et al. 2007 Definition of CP. Dev Med Child Neurol Suppl. 2007;109(April):8-14