Status:
RECRUITING
Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Women's Health Research Institute of British Columbia
Conditions:
Prematurity
Eligibility:
All Genders
26-30 years
Phase:
NA
Brief Summary
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...
Detailed Description
Pilot trial implementation targets: Targets for success would be that the informed consent rate will be at least 40%, 30 patients will be enrolled in 48 months, 95% of infants will receive the 3 hour...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04911452
Start Date
September 27 2021
End Date
December 31 2025
Last Update
January 1 2025
Active Locations (1)
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1
British Columbia Women's Hospital and Health Centre
Vancouver, British Columbia, Canada, V6H 3N1