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Relationship between brain structure and function of very preterm infants to predict neurodevelopmental outcome

Prospective longitudinal study of the relationship between brain structure and function in infants born at less than 30 weeks gestation to predict neurodevelopmental outcome.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613000280707
Acronym
PPREMO - Prediction of PREterm Motor Outcomes
Enrollment
119
Registered
2013-03-08
Start date
2013-02-11
Completion date
2016-04-21
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Infants born prematurely (< 30 weeks gestational age) have a higher risk of developing cerebral palsy than infants born at term, due to immaturity of the developing brain at birth, and potential brain injuries that can occur in the neonatal period. Cerebral palsy is frequently not diagnosed till the second year of life, delaying the start of early intervention treatments which may be of benefit in minimising functional limitations and providing key family supports. To date magnetic resonance imaging (MRI) at term equivalent age and general movement assessment provide the most accurate prediction of neurodevelopmental outcome at 12 months corrected age. This project aims to investigate the relationship between earlier brain MRI and neuromotor/neurobehavioural assessments at 30 weeks gestational age, and their ability to predict outcomes of cerebral palsy and motor difficulties at 3 and 12 months corrected age. We aim to achieve this in a longitudinal prospective cohort study of 80 infants born at less than 30 weeks gestational age, at the Royal Brisbane and Women’s Hospital. Infants will undergo a brain MRI scan at 30 and 40 weeks gestational age to develop our understanding of very early brain structure at 30 weeks; and maturation that occurs between 30 and 40 weeks gestational age. A combination of neurological (Dubowitz neurological assessment), neuromotor (General Movements, Test of Infant Motor Performance, visual functions) and neurobehavioural assessments (the NICU Network Neurobehavioural Scale) will be performed at 30 and 40 weeks GA to understand the relationship between brain structure and function. These data will be compared to motor assessments at 12 weeks post term and 12 months corrected age. These data will be compared to outcomes at 12 months CA including a developmental assessment by a paediatrician (Bayley scales of Infant and Toddler Development), motor assessments (Alberta Infant Motor Scale, Neurosensory Motor Developmental Assessment) to differentiate atypical development (including cerebral palsy and/or motor delay). At a time of increasing demand on health care resources, reliable ways of predicting neurodevelopmental outcome in premature infants is desirable to determine those that may benefit most from early intervention.

Interventions

Preterm Group Infants will be assessed at 4 time-points: 1. At 30 weeks of age, while the infant is still in the nursery we will carry out the following: -clinical and medical information will be collected from the infant's chart -A General Movements Assessment (GMs) which involves video of spontaneous movements in their incubator or cot (up to 1 hour of video; no handling of the baby) -A neurological/neurobehavioural assessment (15-20 minutes; involves a small amount of handling) -A brain sc

Preterm Group Infants will be assessed at 4 time-points: 1. At 30 weeks of age, while the infant is still in the nursery we will carry out the following: -clinical and medical information will be collected from the infant's chart -A General Movements Assessment (GMs) which involves video of spontaneous movements in their incubator or cot (up to 1 hour of video; no handling of the baby) -A neurological/neurobehavioural assessment (15-20 minutes; involves a small amount of handling) -A brain scan (MRI) using MRI compatible incubator which takes about an hour (20 minutes preparation and 40 minutes in the scanner). Infant is fed, wrapped and asleep during the scan, with no sedation used. 2. At 40 weeks which is term equivalent age; if the infant has returned home the family will be asked to visit the hospital. We will complete: - A General Movements Assessment (GMs) which involves video of spontaneous movements (up to 1 hour of video; no handling of the baby) -Movement assessments and a neurological assessment (30-40 minutes) -Assessment of their visual functions (5 minutes) -A brain scan (MRI) using MRI compatible incubator which takes about an hour (20 minutes preparation and 40 minutes in the scanner). Infant is fed, wrapped and asleep during the scan, with no sedation used. -A recording of their brain’s electrical activity (EEG; 30 minutes preparation and 30 minutes recording). 3. At 12 weeks corrected age (3 months after term); the research team will visit the family at home and: - GMs assessment (video the baby’s spontaneous movements for 5-15 minutes) - Perform a movement assessment (40 minutes) - Assess their visual function (5 minutes) 4. At 12 months corrected age; we will ask the family to visit the hospital: - A paediatrician will assess the baby’s general development (30 minutes) - We will perform movement assessments (1 1/2 hours)

Sponsors

Professor Paul Colditz
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
0 to 30 Weeks
Healthy volunteers
Yes

Inclusion criteria

Infants born at less than 30 weeks gestational age English speaking family Live within 200km of the Royal Brisbane and Women's Hospital Have no congenital or chromosomal abnormality that would impact their development

Exclusion criteria

Infants born at greater than 30 weeks gestational age Non English-speaking family Live >200km from the Royal Brisbane and Women's Hospital Have a congenital or chromosomal abnormality that would impact their development

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026