Efficacy of cycled environmental light and noise during initial hospitalisation for improved cognitive outcomes at 2 years in infants born extremely or very preterm: study protocol for the prospective, randomised, open, blinded endpoint controlled multicentre CIRCA DIEM trial
Abstract
Introduction: Very preterm infants (<32 weeks gestation) have an undeveloped primary endogenous circadian rhythm and are deprived abruptly of vital maternal circadian inputs after delivery. Postnatal care in neonatal intensive care units is characterised by constant levels of lighting and noise. Stress arising from disrupted cues for circadian rhythmicity likely disrupts development of coordinated circadian rhythms critical for neurogenesis, organ growth and development. We hypothesise that cycled environmental light and noise commenced soon after birth and continued until discharge home will improve cognitive outcomes compared with infants whose postnatal care comprises constant light (bright or dim) and constant noise.
Methods and analysis: Australasian multicentre, two-arm, parallel-group, prospective, randomised, open, blinded-endpoint superiority trial in 868 infants born less than 32 weeks' gestation. Infants are randomised to cycled environmental light and noise or routine care in a non-cycled hospital environment from soon after birth until discharge home. The intervention comprises wearing eye-masks and ear plugs from 20:00 to 6:00, followed by removal of these devices and exposure to normal environmental noise and 300-600 lux light from 6:00 to 20:00. The primary outcome is composite cognitive score on Bayley-4 developmental assessment at 2 years corrected postnatal age.
Ethics and dissemination: The trial is approved by the Child and Adolescent Health Service…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 868 participants or records.
Read the paper
Related studies
- Tryptophan Metabolism and Gut-Brain Homeostasis
- Rationale for a Multi-Factorial Approach for the Reversal of Cognitive Decline in Alzheimer’s Disease and MCI: A Review
- Prioritized Research for the Prevention, Treatment, and Reversal of Chronic Disease: Recommendations From the Lifestyle Medicine Research Summit
- Relationship between sleep disorders and gut dysbiosis: what affects what?
- The role of CLOCK gene in psychiatric disorders: Evidence from human and animal research
- Genetic, Transcriptome, Proteomic, and Epidemiological Evidence for Blood-Brain Barrier Disruption and Polymicrobial Brain Invasion as Determinant Factors in Alzheimer’s Disease
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.