None listed
Conditions
Brief summary
Prematurity remains common, and infants born prematurely have an increased risk of brain injury. “Encephalopathy of prematurity” refers to brain dysfunction and injury in preterm infants due to a variety of processes. It is known to be an important risk factor for adverse neurodevelopmental outcomes, however a thorough understanding of the causes, clinical presentation, evolution, and outcomes has not been fully established. The aim of this study is to better identify, understand and predict encephalopathy in preterm infants. This is an observational prospective cohort study that investigates babies born at less than 29 weeks’ gestation. Data will be collected on antenatal history, birth and resuscitation details, progress, clinical examinations and investigations in the Neonatal Intensive Care Unit (NICU). For the study, participants will undergo additional periods of brain monitoring and brain imaging. Video recordings will also be taken of routine neurological examinations at certain timepoints. Data will then be collected from routine developmental progress. Data will then be collected from the routine neurodevelopmental follow-up appointments at 12-14 weeks and 24-30 months corrected age. Outcomes of the study have the potential to improve the identification and care of infants at risk of encephalopathy, and better understand their prognosis. A better understanding of the condition may pave the way for future studies on targeted therapies to improve neonatal neurological and developmental outcomes.
Interventions
This is an observational prospective cohort study that investigates babies born at less than 29 weeks’ gestation, including those infants with evidence of exposure to perinatal hypoxia-ischaemia. Data will be collected on antenatal history, birth and resuscitation details, progress, clinical examinations and investigations in the Neonatal Intensive Care Unit (NICU). For the study, participants will undergo additional periods of 1) brain monitoring including Near Infrared Spectroscopy (NIRS), ele
This is an observational prospective cohort study that investigates babies born at less than 29 weeks’ gestation, including those infants with evidence of exposure to perinatal hypoxia-ischaemia. Data will be collected on antenatal history, birth and resuscitation details, progress, clinical examinations and investigations in the Neonatal Intensive Care Unit (NICU). For the study, participants will undergo additional periods of 1) brain monitoring including Near Infrared Spectroscopy (NIRS), electroencephalogram (EEG) and amplitude-integrated electroencephalogram (aEEG), and 2) brain imaging including cranial ultrasound (CrUSS) and Magnetic Resonance Imaging (MRI) of the brain. Video recordings will also be taken of routine neurological examinations at certain timepoints. Data will be collected from routine neurological and developmental assessments in the NICU including General Movements Assessment (GMA) and Hammersmith Neonatal Neurological Examination (HNNE). Data will then be collected from the routine neurodevelopmental follow-up appointments at 12-14 weeks including GMA and Hammersmith Infant Neurological Examination (HINE) and 24-30 months corrected age (Bayley-4). Outcomes of this exploratory prospective observational cohort study include: 1. Report the incidence of all cause encephalopathy, including contribution of perinatal hypoxia-ischaemia 2. Describe the pattern and evolution of encephalopathy in preterm infants 3. Describe the relationship between manifestations of encephalopathy and neurodevelopmental outcome at 12-14 weeks corrected age, and at 24-30 months corrected age.
Sponsors
Monash Health
Eligibility
Sex/Gender
All
Age
0 to 48 Hours
Healthy volunteers
No
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
Outcome results
None listed