e-PINO: early Prediction of Infant Neurodevelopmental Outcomes using novel biomarkers

Not Applicable

Recruiting

• Conditions: Brain development in preterm infants; Cerebral Palsy; Nature/mechanism of brain injury very early in the fetal or neonatal period; Neurological - Other neurological disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12623000672651
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-21
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

Infant’s admitted to the Neonatal Intensive Care Units at the (i) Royal Brisbane and Women’s Hospital (ii) Monash Children’s Hospital (iii) Westmead Hospital and Westmead Children’s Hospital will be invited to participate if they meet the following inclusion criteria (1) six groups neonates (n=540) Preterm-born with any birth weight (BW), very preterm (VPT) less than 32 weeks,
(ii) Moderate to Late Preterm MLPT (Born 32-37 weeks)
(iii) near-term small for gestational age (SGA) (BW less than 10th percentile) or with Fetal Growth Restriction (FGR);
(iv) Term born with Hypoxic ischemic encephalopathy (HIE) and/or stroke;
(v) Healthy Term (HT); (2) no known chromosomal abnormalities; (3) inborn at Royal Brisbane/Monash/Westmead Hospitals; (4) live within 200 km; (5) English spoken.

Exclusion Criteria

Have a congenital or chromosomal abnormality that would impact their development

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Developmental evaluation using the Bayley Scales of Infant and Toddler Development, 4th Edition: Australian and New Zealand Standardised Edition (Bayley-4 A&NZ)[ 24 Months Corrected Age<br> ]; Diagnosis of Cerebral Palsy made by a paediatrician/neonatologist using MRI and clinical assessments[ 24 Months Corrected Age];Evaluation of spontaneous movement using the General Movements Assessment in combination with General Movements Motor Optimality Scoring.[ 40 weeks gestational age (TEA) and 3 months corrected age.]