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

Study identification

• EU PAS number:
  EUPAS35709
• Study ID:
  45926
• Official title and acronym:
  Amplitude integrated electroencephalography as a prognostic value of neurodevelopment in preterm newborns.
• DARWIN EU® study:
  No
• Study countries:
  Lithuania
• Study description:
  Over the last decade, the survival of premature babies has improved. Such infants are still affected by dangerous complications occurring during the neonatal period that often cause brain damage. It requires more specialized monitoring of brain function during this critical period. In recent years, many studies on very premature infants have shown that aEEG has a high predictive value for both short-term and long-term outcome. Most recent studies have shown that an aEEG performed in the early hours or during the first days or weeks of life can predict the neurodevelopment of preterm infants at 1 year of corrected age (Bayley Scale). The aim of our study is to determine the prognostic value of amplitude integrated electroencephalography (aEEG) recorded during the neonatal period for the psychomotor development of very preterm infants at the 12-month corrected age. Inclusion Criteria:Patients must meet all the following criteria to be eligible for this study:1. All infant from 22 to 31 week of gestation age, who were born and treated in Hospital Of Lithuanian University Of Health Sciences, Kaunas Clinics.2. The consent of both parents was obtained.Exclusion Criteria:Patients meeting any of the criteria below will not be included in this study:1. There is no written consent from both parents.2. Multiple developmental defects and chromosomal abnormalities, metabolic diseases.3. Progressive post-hemorrhagic hydrocephalus.It is planned to collect the number of subjects: 200.Duration of the study 3 years.
• Study status:
  Planned

Research institutions and networks

Institutions

Lithuanian University Of Health Scinces

Study timelines

Date when funding contract was signed

Planned:01/04/2020

Study start date

Planned:09/06/2020

Data analysis start date

Planned:01/09/2022

Date of interim report, if expected

Planned:31/12/2022

Date of final study report

Planned:31/12/2023

Sources of funding

Other

More details on funding

Lithuanian University Of Health Sciences, Hospital Of Lithuanian University Of Health Sciences, Kaunas Clinics., Lithuanian Science Council

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable