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The CIRCA DIEM KIDS Study: Assessment of developmental and health outcomes at 5-8 years of children born preterm who were participants in the CIRCA DIEM study of cycled light and noise as babies.

Cognitive and sensory functioning at 5-8 years in children born preterm who were participants in the CIRCA DIEM randomised controlled trial of cycled light and noise as babies.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000707369
Acronym
CIRCA DIEM KIDS
Enrollment
703
Registered
2026-06-12
Start date
2026-08-01
Completion date
2033-06-30
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

CIRCA DIEM KIDS is a prospective observational follow-up at 5-8 years of children born before 32 weeks of gestation who were enrolled in the CIRCA DIEM Study (ACTRN12618000371291) during their initial hospitalisation after birth. The CIRCA DIEM study (ACTRN12618000371291) aimed to determine whether cycling light and noise during initial hospital care improve brain development and overall well-being compared with routine care with constant levels of light and noise during both daytime and nighttime. This follow-up study aims to establish if exposure to this cycled environmental care in the neonatal period has longer term benefits including improved intellectual performance at 5-7 years, and improved vision, hearing, breathing, sleep, school performance and general quality of life.

Interventions

Infants were randomised to either cycled light and noise or to routine non-cycled environmental care during the initial hospitalisation after preterm birth as participants in the parent CIRCA DIEM Study (ACTRN12618000371291). The CIRCA DIEM KIDS study will follow the CIRCA DIEM participant cohort as they reach 5-8 years of age to assess their neurodevelopment, growth, and general wellbeing including sleep and chronotype. Parents or caregivers of study participants will be asked to bring their

Infants were randomised to either cycled light and noise or to routine non-cycled environmental care during the initial hospitalisation after preterm birth as participants in the parent CIRCA DIEM Study (ACTRN12618000371291). The CIRCA DIEM KIDS study will follow the CIRCA DIEM participant cohort as they reach 5-8 years of age to assess their neurodevelopment, growth, and general wellbeing including sleep and chronotype. Parents or caregivers of study participants will be asked to bring their child to a core clinical assessment for general well being (approximately 1 hour) by a research nurse or physician, as well to have a developmental assessment (Weschler Preschool and Primary Scale of Intelligence - WPPSI; approximately 1.5-2 hours) to assess intelligence, performed by appropriately qualified staff (psychologist, medical practictioner, child therapist). Assessments will be undertaken at clinical assessment centres. Parents will also be asked to complete questionnaires relating to their child's behaviour, sleep patterns, quality of life, and general development and well-being. Additionally, participants will be asked to be involved in one or more CIRCA DIEM KIDS Substudies (to be described under additional linked ANZCTRN) to assess vision, hearing, and respiratory function, and to quantify sleep using actigraphy. Some children will also be enrolled in a biological substudy to contribute biological samples (blood, saliva, buccal swabs, nasal lining fluid, nasal brushings, urine and faeces) to investigate immune, microbiological, circadian and respiratory biology after early exposure to cycled light and noise.

Sponsors

The Kids Research Institute Australia
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
All
Age
5 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

• Participant in the parent CIRCA DIEM Study (ACTRN12618000371291) • Informed parental/guardian consent • Age at least 5 years postnatal age (PNA): (range 60 to 95 months) • Survival to 5 years chronological age

Exclusion criteria

• Parents/guardians previously indicated non-willingness to be contacted for future research projects related to The CIRCA DIEM Study. (ACTRN12618000371291). • Post-discharge survival to 5 years (or date of initial recruitment contact – whichever is the later) not confirmed or known death.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 29, 2026