ACUTE AND CHRONIC ACETAMINOPHEN OVERDOSE IN PEDIATRIC POPULATION: PROSPECTIVE STUDY OF COHORT TO EVALUATE CLINIC FACTORS AND BIOMARKERS TO PREDICT DEVELOPMENT OF HEPATOTOXICITY/SOBREDOSIS AGUDA Y CRÓNICA DE PARACETAMOL EN POBLACIÓN PEDIÁTRICA: ESTUDIO PROSPECTIVO DE COHORTES PARA EVALUAR LOS FACTORES CLINICOS Y BIOMARCADORES PREDICTORES DE HEPATOTOXICIDAD (GEIPA-2012-01)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Biomarkers detection, pharmacokinetics

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Pharmacokinetic study, Pharmacogenetics, metabonomics

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N02BE01) paracetamol

  paracetamol
• Medical condition to be studied:
  Hepatotoxicity

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  180

Study design details

• Main study objective:
  1. To determine the clinical factors and biomarkers (pharmacokinetic, genetic and metabonomics) that predict the development of hepatotoxicity in paediatric population following acute and chronic intake of acetaminophen.2. Develop a predictive model to assess the risk of hepatotoxicity in acute and chronic intoxication by acetaminophen suited to paediatric patients for use in clinical practice
• Data analysis plan:
  To estimate differences between variables are used chi-square or T student if parametric. And if it does not follow a normal distribution, nonparametric tests will be used. To determine the factors associated with liver damage will design a multivariate logistic regression where the dependent variable is the presence of hepatotoxicity and a multivariate linear regression to determine the relationship between transaminase values ​​and factors (demographic, clinical, kinetic, analytical, genetic and metabonómics).