Remote Ischemic Conditioning in Necrotizing Enterocolitis: Feasibility and Safety Pilot Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Enterocolitis, Necrotizing
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Limb perfusion after Remote Ischemic Conditioning
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 pathogenesis is multifactorial, but bowel ischemia plays an essential role in NEC development. Remote ischemic conditioning (RIC) consists in inducing brief periods of non-lethal ischemia in a limb distant to an organ suffering from ischemia. RIC has been used in adults, children and term neonates with a variety of diagnosis. However, no study has been done including preterm infants with NEC.
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 relation to duration of ischemia time, number of cycles of RIC and whether it is feasible and safe to perform RIC on consecutive days.
Investigators
Agostino Pierro
Head of The Division of General and Thoracic Surgery
The Hospital for Sick Children
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Patients with major congenital anomalies
- •No antecedent of limb ischemia/limb thrombotic events.
- •No antecedent diagnosis of occlusive arterial or venous thrombosis
- •Hemodynamic instability
Outcomes
Primary Outcomes
Limb perfusion after Remote Ischemic Conditioning
Time Frame: 1 days
Limb perfusion will be assessed before (baseline) and after Remote Ischemic Conditioning (RIC). Limb perfusion will be determined by oxygen saturation using pulse oximetry. RIC will be considered feasible and safe if the procedure is completed as planned with no failure of limb re-perfusion. Failure is defined as no return of limb arterial oxygen saturation to baseline 4 minutes after the ischemic phase (re-perfusion time).
Secondary Outcomes
- Cutaneous injury(1 days)
- Persistent pain(1 days)