Encephalopathy in the Preterm Infant

Not Applicable

• Conditions: Prematurity; Neurological - Studies of the normal brain and nervous system; Encephalopathy; Brain injury in the preterm infant; Brain development in the preterm infant; Neurological - Other neurological disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12624000104550
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-07
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Infants less than 29 weeks’ gestational age at birth and admitted to the neonatal intensive care unit
- Less than or equal to 48 hours age at the time of recruitment

Exclusion Criteria

- Infants >29 weeks’ gestation at birth
- >48 hours age at the time of recruitment

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Report the incidence of all cause encephalopathy, including contribution of perinatal hypoxia-ischaemia <br><br>[Incidence of encephalopathy is the primary outcome. Infants will be defined as having encephalopathy if they meet one or more of the following criteria: <br>- Abnormal neurological examination at one or more time points, OR <br>- Abnormal gestation specific amplitude integrated electroencephalogram (aEEG) OR <br>electroencephalogram (EEG) background pattern, OR <br>- Presence of electrographic seizures on aEEG or EEG <br> Term corrected age ]

Secondary Outcome Measures

Name	Time	Method
Describe the pattern and evolution of encephalopathy in preterm infants<br>[Incidence of encephalopathy (as defined above) at each study time point. <br>Descriptive statistics on infants with and without encephalopathy on pregnancy, birth, neonatal course, and study examination/investigation parameters. Term corrected age ];Neurodevelopmental outcome at 12-14 weeks corrected age[GMA and HINE 12-14 weeks corrected age and<br>];Neurodevelopmental outcome at 24-30 months corrected age[Bayley-4 24-30 months corrected age ]