The CIRCA DIEM Study

 Study baby with ear and eye protection

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

Lead Investigators: Professor Jane Pillow; Clin Assoc Professor Mary Sharp

Summary: The CIRCA DIEM study is a multicentre, prospective, blinded end-point (PROBE) parallel controlled trial which compares long term neuro-developmental outcomes of premature babies shielded from light and sound during night time, with neuro-developmental outcomes of premature babies who receive routine care.

The circadian rhythm is the body’s ‘internal clock’ which controls many biological processes and behaviours. The body’s circadian rhythm usually aligns with day and night.

An alternating light and dark cycle is a critical part of the signal that is sent to the brain to release the hormones necessary for sleepiness (melatonin) and wakefulness (cortisol). Sleep without interruption is important for brain development and overall health.

Circadian rhythms are vital for normal fetal development. While in the uterus, the developing fetus is dependent on their mother’s circadian rhythms until a few days before birth.

Infants born prematurely do not share the last weeks of their mother’s circadian rhythms. Premature infants spend the first weeks of their lives cared for in incubators in Neonatal Intensive Care Units (NICUs) exposed to the light and noise of hospital neonatal intensive care units during both the day and night.

Every night from 8pm until 6am the next morning, the infants in the study group wear little black-out eye masks and silicone ear plugs.

This CIRCA DIEM study will compare the long-term neuro-developmental outcomes of premature babies who were shielded from light and sound during night time, with premature babies who received routine care. Heart and lung disease assessments are included in the short-term study outcomes at hospital discharge.

(ANZCTR) Trial Registry Number: ACTRN12618000371291p

Funding: Telethon Perth Children's Hospital Research Fund

This study has approval from the Child and Adolescent Health Service Human Research Ethics Committee based in Western Australia, who can be contacted via CAHS.Ethics@health.wa.gov.au or by telephoning (08) 6456 0561.