Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000591550
Ethics application status
Approved
Date submitted
21/05/2015
Date registered
5/06/2015
Date last updated
26/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Neurodevelopment of the preterm infant
Scientific title
Neurodevelopment of the preterm infant
Secondary ID [1] 286563 0
Nil
Universal Trial Number (UTN)
U1111-1169-4479
Trial acronym
PREBO - Preterm Brain Outcomes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain development in preterm infants 294813 0
Prematurity 294814 0
Condition category
Condition code
Neurological 295088 295088 0 0
Other neurological disorders
Reproductive Health and Childbirth 295089 295089 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
Preterm Group
Infants will be assessed at 4 time-points:
1. At 30-36 weeks gestational age, while the baby is still in the nursery we will carry out the following:
- clinical and medical information will be collected from the baby's chart
- a General Movements Assessment (GMs) which involves video of spontaneous movements in their incubator or cot (no handling of baby)
- a neurological/neurobehavioural assessment (involves a small amount of handling)
- a brain scan (MRI) using MRI compatible incubator. Infant is fed, wrapped and asleep during the scan, with no sedation used.
- a recording of the baby's brain electrical activity (EEG)

2. At term (40-42 weeks) gestational age; if the baby has returned home the family will be asked to visit the hospital. We will complete:
- a video of the baby's movements for a short period
- movement assessments and a neurological assessment. This assessment is videoed for scoring purposes
- assessment of the baby's visual functions
- a brain scan (MRI) using MRI compatible incubator
- a recording of the baby's brain electrical activity (EEG)

3. At 3 months corrected age we will visit the family at home and:
- GMs assessment (video the baby's spontaneous movements)
- perform a movement assessment. This assessment is videoed for scoring purposes.
- assessment of the baby's visual functions

4. At 12 months corrected age ( Brisbane site only) we will visit the family at home and:
-to perform neurodevelopment and movement assessments.These assessments are videoed for scoring purposes.
-a paediatrician assessment will be performed if required.

5. At 24 months corrected age we will ask the family to visit the hospital for:
- a paediatrician to assess the baby's general development
- to perform neurodevelopment and movement assessments. These assessments are videoed for scoring purposes.
Intervention code [1] 291669 0
Not applicable
Comparator / control treatment
Reference group of healthy, full term infants.
Assessed at > 1 week of age:
- a brain scan (MRI) using MRI compatible incubator. Infant is fed, wrapped and asleep during the scan, with no sedation used.
- movement assessments and a neurological assessment
- assessment of the baby's visual functions
- a recording of the baby's brain electrical activity (EEG)
Control group
Active

Outcomes
Primary outcome [1] 294850 0
Brain neuroimaging
Structural and diffusion imaging analyses will be performed, including high angular resolution diffusion imaging (HARDI). This will examine both the structural integrity, and structural connectivity of the brain. These data will be related to outcome at 24 months corrected age (CP/not CP)
Timepoint [1] 294850 0
An MRI will be performed at 30 weeks and 40 weeks post menstrual ages (PMA).
Secondary outcome [1] 314195 0
Prechtl's method on the qualitative assessment of general movements. The flow and spontaneity of movements from the infant will be correlated with neurological health scores from the EEG, MRI and Dubowitz neurological assessment.
Timepoint [1] 314195 0
The General Movement's Assessment will be performed by scoring video recordings of the infant's spontaneous movements at 30 weeks PMA, 40 weeks PMA, and 3 months CA.
Secondary outcome [2] 314196 0
Electrophysiology.
EEG recordings will be obtain from all infants. A quantitative assessment of the EEG will be performed, including coherence analysis and spectral analysis.
Timepoint [2] 314196 0
The EEG will be performed at 30 and 40 weeks PMA in the preterm group, and at term in the reference group.
Secondary outcome [3] 314197 0
Neurological assessment
The Dubowitz neurological assessment assesses posture and tone, reflexes, movements and neurobehavioural responses.
Timepoint [3] 314197 0
The Dubowitz assessment will be performed at 30 and 40 weeks PMA in the preterm group, and at term in the reference group.
Secondary outcome [4] 314198 0
The NICU Network Neurobehavioural Scale (NNS) is designed to provide information relating to an infant's development, behavioural maturation, central nervous system integrity and stress responses (Lester and Tronick 2004).
Timepoint [4] 314198 0
The NNS will be performed at 30 and 40 weeks PMA in the preterm group, and at term in the reference group.
Secondary outcome [5] 314199 0
Visual assessment
The neonatal assessment of visual functions provides useful information on the various aspects of early neonatal visual function, including ocular motility, fixation, following, acuity and attention to distance. When the baby is alert they will be tested to see how they look at (fixes and follows) a series of cards designed to test their vision.
Timepoint [5] 314199 0
This assessment will be performed at term equivalent age in the preterm and term reference group.
Secondary outcome [6] 314200 0
Test of Infant Motor Performance (TIMP)
The test assesses the postural and selective control of movement needed for functional motor performance in early infancy.
Timepoint [6] 314200 0
The TIMP will be performed at term equivalent age and 3 months corrected age in the preterm group.
Secondary outcome [7] 314201 0
Medical assessment - single outcome
Infants in this study will be independently assessed by a paediatrician experienced in infant development. The purpose of this assessment is to discriminate which infants are developing typically from those who are not, and to confirm diagnoses of CP or not CP (Badawi 1998). In cases of CP, motor type and distribution wil be recorded, and severity established through classification with the Gross Motor Function Classification System (GMFCS). Any additional medical diagnoses that have been made by this stage will be recorded.
Timepoint [7] 314201 0
Infants in the preterm group and term reference group will undergo this medical assessment at 24 months corrected age.
Secondary outcome [8] 314202 0
Assessment of Motor and neurodevelopmental outcome:
Bayley Scales of Infant and Toddler Development III (Bayley III - a discriminative tool designed to assess cognitive, language and motor development).
Timepoint [8] 314202 0
Infants in the preterm group and term reference group will have these assessments at 24 months corrected age.
Secondary outcome [9] 315031 0
Assessment of Motor and neurodevelopmental outcome:
Neurosensory Motor Developmental Assessment (NSMDA - examines gross and fine motor performance, neurological status, posture, balance and response to sensory input).
Timepoint [9] 315031 0
Infants in the preterm group and term reference group will have these assessments at 24 months corrected age.
Secondary outcome [10] 315032 0
Assessment of Motor and neurodevelopmental outcome:
Alberta Infant Motor Scale (AIMS - tests gross motor skills through the components of weight bearing, posture and anti-gravity movements).
Timepoint [10] 315032 0
Infants in the preterm group and term refernce group will have these assessments at 24 months corrected age.

Eligibility
Key inclusion criteria
PRETERM GROUP
Infants born at less than 31 weeks gestational age
English speaking family
Live within 200km of either the Royal Brisbane and Women's Hospital or Monash Medical Centre
Have no congenital or chromosomal abnormality that would impact their development

TERM REFERENCE GROUP
Infants born between 38 and 41 weeks postmenstrual age
English speaking family
Live within 200km of either the Royal Brisbane and Women's Hospital or Monash Medical Centre
Have no congenital or chromosomal abnormality that would impact their development
Minimum age
No limit
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
PRETERM GROUP
Infants born at greater than 31 weeks gestational age
Non English-speaking family
Live >200 km from the Royal Brisbane and Women's Hospital or Monash Medical Centre
Have a congenital or chromosomal abnormality that would impact their development

TERM REFERENCE GROUP
Infants born at less than 38 weeks gestational age
Non English-speaking family
Live >200 km from the Royal Brisbane and Women's Hospital or Monash Medical Centre
Have a congenital or chromosomal abnormality that would impact their development

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2015
Actual
9/03/2016
Date of last participant enrolment
Anticipated
1/02/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
237
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment postcode(s) [1] 9539 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 9540 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 291125 0
Government body
Name [1] 291125 0
National Health and Medical Research Council
Country [1] 291125 0
Australia
Primary sponsor type
Individual
Name
Professor Paul Colditz
Address
Perinatal Research Center
The University of Queensland Centre for Clinical Research
Building 71/918
Royal Brisbane and Women's Hospital
Herston Rd
QLD 4029
Country
Australia
Secondary sponsor category [1] 289800 0
Individual
Name [1] 289800 0
Professor Roslyn Boyd
Address [1] 289800 0
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Level 6, Centre for Children's Health Research, 62 Graham Street, South Brisbane Qld 4101
Country [1] 289800 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292704 0
Children's Health Queensland HREC
Ethics committee address [1] 292704 0
Ethics committee country [1] 292704 0
Australia
Date submitted for ethics approval [1] 292704 0
21/01/2015
Approval date [1] 292704 0
18/02/2015
Ethics approval number [1] 292704 0
HREC/15/QRCH/7

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

Contacts
Principal investigator
Name 56654 0
Prof Paul Colditz
Address 56654 0
Perinatal Research Centre
Level 4, UQCCR
Building 71/918
Royal Brisbane and Women's Hospital
Herston
Qld 4029
Country 56654 0
Australia
Phone 56654 0
+61 7 33466014
Fax 56654 0
+61 7 33465594
Email 56654 0
[email protected]
Contact person for public queries
Name 56655 0
Paul Colditz
Address 56655 0
Perinatal Research Centre
Level 4, UQCCR
Building 71/918
Royal Brisbane and Women's Hospital
Herston
Qld 4029
Country 56655 0
Australia
Phone 56655 0
+61 7 33466014
Fax 56655 0
+61 7 33465594
Email 56655 0
[email protected]
Contact person for scientific queries
Name 56656 0
Paul Colditz
Address 56656 0
Perinatal Research Centre
Level 4, UQCCR
Building 71/918
Royal Brisbane and Women's Hospital
Herston
Qld 4029
Country 56656 0
Australia
Phone 56656 0
+61 7 33466014
Fax 56656 0
+61 7 33465594
Email 56656 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseIdentifying Emergent Mesoscopic-Macroscopic Functional Brain Network Dynamics in Infants at Term-Equivalent Age with Electric Source Neuroimaging.2021https://dx.doi.org/10.1089/brain.2020.0965
EmbaseEarly Motor Repertoire of Very Preterm Infants and Relationships with 2-Year Neurodevelopment.2022https://dx.doi.org/10.3390/jcm11071833
N.B. These documents automatically identified may not have been verified by the study sponsor.