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Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants

RecruitingNAAges 26 Weeks - 30 WeeksAllUniversity of British Columbia
NCT04911452 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin care (SSC) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSC; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSC; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 p

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📋 Eligibility rules (as published)
Inclusion Criteria: * Preterm infants admitted to the neonatal intensive care unit (NICU) at the British Columbia (BC) Women's Hospital born at 26-30 completed weeks gestational age (GA). GA is determined accurately using early gestation ultrasonogram (standard of care in BC), or calculated using the last menstrual period; * Infants who are on continuous positive airway pressure or are ventilated; * At least one parent/caregiver must speak sufficient English to provide consent Exclusion Criteria: * Infants who have congenital anomalies, small for GA (per medical admission history), or have a history of maternal abuse of controlled drugs and substances; - Infants with an ongoing infection at the time of enrolment; * Infants that have pre-existing cardiovascular instability defined by shock/hypotension/need for cardiovascular drugs * Infants receiving paralytic drugs; * Infants that have major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage/stroke); * Infants who are beyond the 30th completed week GA (30 weeks + 6 days) at enrolment.
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What it tests

  • Calmer
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Where

1 site
British Columbia Women's Hospital and Health Centre
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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