RecruitingACTRN12615000591550

Neurodevelopment of the preterm infant


Sponsor

Professor Paul Colditz

Enrollment

237 participants

Start Date

Mar 9, 2016

Study Type

Observational

Conditions

Summary

The infant born very preterm (23-31 weeks gestation) is at high risk of an adverse neurodevelopmental outcome (10% cerebral palsy, 50% learning and behavioural difficulties at school age) which, if present, results in costs of billions of dollars annually in Australia. Currently there is no accurate way to either predict the motor, cognitive and neurobehavioural outcomes in these high-risk infants or to adequately monitor structural and functional brain development. Cerebral palsy is often not diagnosed until the second year of life and cognitive and educational disability even later. As a result, early intervention to target those at most risk is not possible. However, in the several months after very preterm birth, the brain is at its maximal capacity for neuroplasticity and repair, which offers a window of opportunity for effective and safe interventions to be implemented to improve outcomes. The purpose of this research is to learn which tests (clinical, MRI and EEG) can be used at 30 weeks and 40 weeks, to accurately identify which babies may have problems later in life, so that those babies and their families can be provided with the help they need as early as possible. We aim to predict adverse neurodevelopment earlier and more accurately than currently possible in a cohort of 237 babies using: (i) advanced brain MRI to determine the structural wiring diagram of the brain ('brain connectome'), (ii) dense array EEG to establish the functional activity or electrical 'traffic' being carried on the main branches of the connectome and (iii) structured clinical neurodevelopmental assessments to provide a cutting edge view of the state of brain development. We aim to achieve this in a prospective longitudinal cohort study of 200 preterm infants born <31 weeks GA, and a reference group of 37 healthy term-born infants. Infants will undergo a brain MRI at 30 and 40 weeks GA to develop our understanding of the brain structure and maturation that occurs between these time points. A combination of neurological, neuromotor and neurobehavioural assessments will be performed at 30 and 40 weeks GA to understand the relationship between brain structure and function. These data will be compared to clinical neurodevelopmental assessments at 3 months, 12 months and 24 months corrected age. We will merge two research teams using Australia's only two MRI compatible incubators (RBWH and Monash Medical Centre) to establish the role of cutting edge approaches in clinical assessment, MRI and EEg methods to improve neurodevelopmental outcomes for preterm infants.


Eligibility

Sex: Both males and femalesMax Age: 2 Yearss

Plain Language Summary

Simplified for easier understanding

This study is following premature babies born before 31 weeks of pregnancy to learn which early brain tests — including advanced MRI brain scans and electrical brain activity measurements (EEG) — can best predict which babies might face learning, movement, or developmental challenges later in life. Early identification can allow earlier help for these babies and their families. You may be eligible if: - Your baby was born before 31 weeks of pregnancy (preterm group), OR - Your baby was born between 38 and 41 weeks (reference group) - Your family speaks English - You live within 200 km of the Royal Brisbane and Women's Hospital or Monash Medical Centre - Your baby has no chromosomal or congenital abnormality affecting development You may NOT be eligible if: - Your baby was born at 31 weeks or later (for the preterm group) - Your family does not speak English - You live more than 200 km from a study site - Your baby has a congenital or chromosomal abnormality Talk to your doctor about whether this trial might be right for you.

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Interventions

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 informatio

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.


Locations(1)

QLD,VIC, Australia

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