Status:
COMPLETED
The Calmer Project
Lead Sponsor:
Children's & Women's Health Centre of British Columbia
Conditions:
Acute Pain
Eligibility:
All Genders
27-36 years
Phase:
NA
Brief Summary
The purpose of this study is to see if the Calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit. Hypothesis:...
Detailed Description
60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
Eligibility Criteria
Inclusion
- Stable infants admitted to the Neonatal Intensive Care Unit at Children's and Women's Health Centre of British Columbia (C\&W)
- Preterm infants born at 27 to 36+6 completed weeks gestational age (GA) will be included
- GA is determined on the basis of the first day of the last menstrual period, early gestation ultrasonogram (in most cases) or best estimate based on neonatal examination
- Mothers must speak enough English to provide consent
Exclusion
- Infants who have congenital anomalies, active, ongoing infection, or have undergone surgery
- Infants who have received pharmacological analgesics or sedatives within 72 hours of the assessment
- History of maternal abuse of controlled drugs and substances; blood collection that occurs beyond the 35th completed week (35 weeks + 6 days) GA
- Small for GA defined as a birth weight at least 2 standard deviations below mean for GA
- Higher order multiples (e.g. triplets)
- Infants in a cot
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01433588
Start Date
October 1 2014
End Date
May 1 2018
Last Update
July 17 2018
Active Locations (1)
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1
BC Children's and Women's Health Centre
Vancouver, British Columbia, Canada, V6H3V4