Autologous cord blood-derived cell therapy for extremely preterm infants: An international, multicentre randomised controlled trial

Phase 2

• Conditions: prematurity; preterm brain injury; Reproductive Health and Childbirth - Complications of newborn; Neurological - Other neurological disorders

• Registration Number: ACTRN12624000968572
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-08
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

Extremely preterm infants born less than 28 weeks completed gestation

Exclusion Criteria

Extremely preterm infants where parental consent could not be obtained, or where a major brain malformation was known antenatally.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival free of moderate-severe neurodisability at 24-30 months of corrected age (moderate-severe disability defined as any component of Bayley-4 (or III as available) scores less than 2 standard deviations (SD), cerebral palsy GMFCS grade >2, deafness, blindness (<6/60) or other moderate-severe neurological impairment)[Assessments at 24-30 months:<br>Bayley -4<br>Gross Motor Function Classification System for cerebral palsy<br>Medical examination and interview<br>Vision and hearing testing 24-30 months of corrected age]