Amplitude integrated electroencephalography as a prognostic value of neurodevelopment in preterm newborns.

08/06/2020
23/02/2022
EU PAS number:
EUPAS35709
Study
Planned
Study type

Study type

Clinical trial

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Clinical trials

Clinical trial randomisation

Non-randomised clinical trial
Population studied

Age groups

  • Preterm newborn infants (0 – 27 days)

Estimated number of subjects

200
Study design details

Main study objective

The aim of our study is to determine the prognostic value of amplitude integrated electroencephalography recorded during the neonatal period for the psychomotor development of very preterm infants at the 12-month corrected age.

Data analysis plan

Amplitude integrated electroencephalography has a high predictive value for both short-term and long-term outcome. It will be possible to provide more help for family of the premature baby, to refer to appropriate professionals. Amplitude electroencephalography provides a minimal intervention outcomes. Subjects will not be given any additional medications. To keep the study confidential, subjects will be given an identification number.