ACTRN12619000969167Recruiting未知
Peer delivered early detection and intervention for infants at high risk of cerebral palsy and neurodevelopmental disabilities in Indigenous Australia
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- The University of Queensland
- Enrollment
- 86
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 3 Months to 12 Months (—)
- Sex
- All
Inclusion Criteria
- •Infants aged 0-9 months CA (early detection sub-study) and 3 to 12 months +2 weeks CA (intervention study), residing in a study geographical area, with one or both parents identifying as Aboriginal or Torres Strait Islander, who are at risk of later adverse neurodevelopmental outcomes due to a history of any of the following factors; birth or pregnancy complications, preterm birth, low birth weight, maternal risk factors, admission to neonatal intensive care unit or special care nursery or post-neonatal complications (infection, head injury, stroke) will be recruited to this study.
- •Infants will be screened and must be assessed as ‘high risk of CP/ NDD’ or have a confirmed diagnosis of CP (confirmed by paediatrician).
- •Infants are determined to be high risk of CP/ NDD if assessed as:
- •(i)‘Absent’ or ‘abnormal’ fidgety on General Movements Assessment for infants aged 12-17 weeks; OR GMA ‘fidgety’ with segmental asymmetries; AND
- •(ii)‘Suboptimal score’ (score<57 at 3m, <60 at 6m, <63 at 9m, <67 at 12m) on the Hammersmith Infant Neurological Examination (90% predictive of CP) if aged >18 weeks; OR ‘normal’ HINE score with 5 or more asymmetries (with confirmation from Hand Assessment in Infants with a 3 point difference between limbs).18 If infants enter the study after 18 weeks CA (ie no GMs assessment), eligibility will be achieved by a score indicating risk on the HINE/ 5 or more asymmetries PLUS a clinical history congruent with a diagnosis of CP; OR
- •(iii)‘Abnormal’ neuroimaging results associated with a motor disability including an abnormality in one or more of the following structures: sensorimotor cortex, basal ganglia, posterior limb of the internal capsule AND (i) OR (ii).
- •The Rapid Neurodevelopmental Assessment (4-9 months CA), Ages and Stages Questionnaire - Aboriginal adaptation (4-9 months CA) and General movements assessment motor optimality score (3-5 months CA) will also be conducted for participants in the early detection sub-study to use in concurrent and predictive validity data for other disabilities.
- •Infants will be screened for eligibility for study inclusion until target of n=86 is reached
Exclusion Criteria
- •Infants with complex medical conditions requiring acute medical care will be excluded
Investigators
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