Status:
COMPLETED
Remote Ischemic Conditioning in Necrotizing Enterocolitis
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Enterocolitis, Necrotizing
Eligibility:
All Genders
Up to 3 years
Brief Summary
Necrotizing enterocolitis (NEC) affects up to 10% of very preterm infants. NEC mortality is high (30-50 %) and has remained unchanged over the last decades. New treatments are urgently needed. NEC pat...
Detailed Description
An appropriately sized blood pressure cuff will be applied to an arm or leg and inflated to promote RIC. This study will be conducted in three phases to assess the feasibility and safety of RIC in rel...
Eligibility Criteria
Inclusion
- Patients with NEC (stages I-III Bell's Classification)
- Weight greater or equal to 750 g.
- Gestational age \< 36 weeks.
- Patients whose parents consent to participate in the study.
Exclusion
- Patients with major congenital anomalies
- No antecedent of limb ischemia/limb thrombotic events.
- No antecedent diagnosis of occlusive arterial or venous thrombosis
- Hemodynamic instability
Key Trial Info
Start Date :
December 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 20 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03860701
Start Date
December 17 2018
End Date
August 20 2019
Last Update
October 22 2020
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8