Effect of early Restoration of CIRCADian rhythms in very preterm Infants via Environmental Modification on Infection in Early Life: The CIRCA DIEM Infection and Immunology Substudy

Not Applicable

• Conditions: Infection; Impaired immunity; Prematurity; Infection - Studies of infection and infectious agents; Inflammatory and Immune System - Normal development and function of the immune system; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12623001073695
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-06
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 636

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 participation in the parent CIRCA DIEM trial (ANZCTRN12618000371291),
•Have consented to participate in the CIRCA DIEM Infection and Immunology substudy

Exclusion Criteria

• 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: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of hospitalisations for bacterial or viral infection (composite outcome). Data will be collected prospectively via study-specific survey and confirmed via data-linkage to medical records.[ 2 years corrected postnatal age]