Cognitive Improvement through early Restoration of cirCADian rhythms in very preterm Infants via Environmental Modification: The CIRCA DIEM Study

Not Applicable

Recruiting

• Conditions: Prematurity; Circadian rhythm; Neurodevelopment; Reproductive Health and Childbirth - Complications of newborn; Neurological - Other neurological disorders

• Registration Number: ACTRN12618000371291
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-12
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 954

Inclusion Criteria

•Are born at < 32 weeks postmenstrual age by best obstetric estimate (inborn or outborn)
•Have initial care at a perinatal centre where routine care does not include individual environmental light/noise cycling
•Have informed parental consent to trial participation, obtained either prior to or after birth. (Consent will be obtained either prior to or after birth, using a specific, parent advisory panel and ethics committee approved information and consent form)

Exclusion Criteria

Update
•Have a congenital neurodevelopmental abnormality
•Are critically ill and not expected to survive to discharge
•Grade IV intracerebral haemorrhage prior to enrolment into study.
•Unlikely to return for a 2 year follow-up
•Intervention unable to be continued until discharge home (step-down discharge unit not participating as a sub-site in the trial)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean difference in cognitive score on Bayley Scales of Infant Development (BSID) - 4th Edition[ 2 years corrected postnatal age (cPNA)]