RecruitingACTRN12619000155190

PREBO-6: Prediction of childhood Brain Outcomes in infants born preterm

PREBO-6: Prediction of childhood Brain Outcomes in infants born preterm using neonatal MRI and concurrent clinical biomarkers


Sponsor

Dr Joanne George

Enrollment

299 participants

Start Date

Jul 18, 2019

Study Type

Observational

Conditions

Summary

Infants born preterm are at risk of adverse long-term neurodevelopmental outcomes, including cognitive, behavioural and motor deficits (including cerebra palsy). These adverse outcomes can significantly impair social and educational functioning and quality of life. We have established a cohort of infants born very preterm (<31 weeks gestation) with early neonatal brain imaging and concurrent clinical assessment of motor, neurological and neurobehavioural function (PREMO - Prediction of Preterm Motor Outcomes, ACTRN12613000280707; PREBO - Prediction of Preterm Brain Outcomes, ACTRN12615000591550). This study now aims to examine whether early MRI scans or clinical assessments can predict a child’s motor, cognitive, language, educational achievement and mental health outcomes at 6 years corrected age. If this is found to be the case, then in future, families will be provided with information on their child’s likely development much earlier. This will enable families to receive support and their children to be offered earlier treatments to help them with their movement, learning or behavioural development.


Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 6 Yearss

Plain Language Summary

Simplified for easier understanding

Babies born very early (before 31 weeks of pregnancy) are at risk of long-term challenges with movement, thinking, learning, and behaviour. Early MRI scans taken of these babies' brains, along with physical and neurological assessments, may be able to predict which children will develop these difficulties. The PREBO-6 study follows up children who participated in earlier research studies (PREMO and PREBO) and examines how they are doing now that they have reached six years of age. At age six, children complete assessments of their motor skills, thinking and language abilities, educational achievement, and mental health. Researchers will see whether the early brain scans and assessments taken when they were babies predicted these later outcomes. If early scans can reliably predict development, families could receive tailored support and early interventions much sooner. Your child may be eligible if they participated in the PREMO or PREBO study as an infant and are now turning six years old (corrected age). They should have been born at less than 31 weeks gestation, or be a term-born comparison child from those studies. Children with chromosomal or congenital abnormalities affecting development, or whose families do not speak English, are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The PREBO-6 study is a prospective follow-up study of a cohort of children born very preterm (<31 weeks gestation) with early neonatal brain imaging and concurrent clinical assessment of motor, neurol

The PREBO-6 study is a prospective follow-up study of a cohort of children born very preterm (<31 weeks gestation) with early neonatal brain imaging and concurrent clinical assessment of motor, neurological and neurobehavioural function (PREMO - Prediction of Preterm Motor Outcomes, ACTRN12613000280707; PREBO - Prediction of Preterm Brain Outcomes, ACTRN12615000591550). We will now perform longer-term follow-up to capture longitudinal data on motor function, cognition, language, educational achievement, mental health and brain structure at 6 years corrected age. This will be a one-off assessment conducted over 2 days.


Locations(2)

Lady Cilento Children's Hospital - South Brisbane

QLD, Australia

Queensland Children's Hospital - South Brisbane

QLD, Australia

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ACTRN12619000155190


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