Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000104550
Ethics application status
Approved
Date submitted
20/12/2023
Date registered
7/02/2024
Date last updated
7/02/2024
Date data sharing statement initially provided
7/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Encephalopathy in the Preterm Infant
Scientific title
Incidence, Characterisation and Evolution of Encephalopathy in the Preterm Infant
Secondary ID [1] 311079 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Prem HI-5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 332224 0
Encephalopathy 332225 0
Brain development in the preterm infant 332335 0
Brain injury in the preterm infant 332336 0
Condition category
Condition code
Neurological 328940 328940 0 0
Other neurological disorders
Neurological 328941 328941 0 0
Studies of the normal brain and nervous system
Reproductive Health and Childbirth 328942 328942 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 327529 0
Diagnosis / Prognosis
Intervention code [2] 327608 0
Early Detection / Screening
Comparator / control treatment
No comparator/control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336737 0
Report the incidence of all cause encephalopathy, including contribution of perinatal hypoxia-ischaemia

Timepoint [1] 336737 0
Term corrected age
Secondary outcome [1] 429523 0
Describe the pattern and evolution of encephalopathy in preterm infants
Timepoint [1] 429523 0
Term corrected age
Secondary outcome [2] 429524 0
Neurodevelopmental outcome at 12-14 weeks corrected age
Timepoint [2] 429524 0
12-14 weeks corrected age and
Secondary outcome [3] 430986 0
Neurodevelopmental outcome at 24-30 months corrected age
Timepoint [3] 430986 0
24-30 months corrected age

Eligibility
Key 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
Minimum age
0 Hours
Maximum age
48 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Infants >29 weeks’ gestation at birth
- >48 hours age at the time of recruitment

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/02/2024
Actual
Date of last participant enrolment
Anticipated
22/02/2027
Actual
Date of last data collection
Anticipated
18/02/2030
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25942 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 25943 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 41776 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 315336 0
University
Name [1] 315336 0
Monash University
Country [1] 315336 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Newborn, 246 Clayton Road, Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 317488 0
University
Name [1] 317488 0
Monash University
Address [1] 317488 0
Department of Paediatrics, 246 Clayton Road, Clayton, VIC, 3168
Country [1] 317488 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314259 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 314259 0
Ethics committee country [1] 314259 0
Australia
Date submitted for ethics approval [1] 314259 0
21/09/2023
Approval date [1] 314259 0
06/10/2023
Ethics approval number [1] 314259 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130962 0
Dr Simone Huntingford
Address 130962 0
Department of Paediatrics, Monash University, Level 5, 246 Clayton Road, Clayton, VIC, 3168
Country 130962 0
Australia
Phone 130962 0
+61 43 8572 3650
Fax 130962 0
Email 130962 0
[email protected]
Contact person for public queries
Name 130963 0
Simone Huntingford
Address 130963 0
Department of Paediatrics, Monash University, Level 5, 246 Clayton Road, Clayton, VIC, 3168
Country 130963 0
Australia
Phone 130963 0
+61 43 8572 3650
Fax 130963 0
Email 130963 0
[email protected]
Contact person for scientific queries
Name 130964 0
Simone Huntingford
Address 130964 0
Department of Paediatrics, Monash University, Level 5, 246 Clayton Road, Clayton, VIC, 3168
Country 130964 0
Australia
Phone 130964 0
+61 43 8572 3650
Fax 130964 0
Email 130964 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.