Remote Ischemic Conditioning in Necrotizing Enterocolitis

The Hospital for Sick Children

Status: Completed

Conditions: Enterocolitis, Necrotizing

Treatments: Procedure: Remote ischemic conditioning

Study type: Observational

Funder types: Other

Identifiers

NCT03860701

REB1000061144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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