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

Abstract

Recent research suggests that our circadian rhythm plays a very important role in how we develop and how our immune system works. The CIRCA DIEM Study (ACTRN12618000371291) is randomising hospitalised premature infants born before 32 weeks gestation to be standard routine care or to be cycled between an artificial night-time from 8 pm to 6 am (using eye masks to block out light and ear plugs to reduce noise) and then to be exposed to an artificial daytime from 6 am to 8 pm (removal of eye masks and ear plugs and light levels from 300-600 lux (similar to low-level office lighting). The intervention continues until babies are discharged home to a normal day/night environment. As part of the CIRCA DIEM trial, we are inviting participating families to enrol their baby into an Infection and Immunology substudy. The main aim of the CIRCA DIEM Infection and Immunology Sub-Study is to find out whether the timing of the development of a circadian rhythm influences the likelihood of premature babies developing infections that require hospitalisation over the first 2 years of life. Babies enrolled in the CIRCA DIEM main study whose parents agree to their participation in the Infection and Immunology Substudy will be followed-up after discharge home using a mobile app to track infant well-being, presence of symptoms of infection, visits to health care providers and hospitalisations. Some infants will also have some biological samples collected to help us understand the mechanism of any differences that are evident between the intervention and control groups with respect to hospitalisations for infections and other secondary substudy outcomes.