NCT03860701

Remote Ischemic Conditioning in Necrotizing Enterocolitis

Remote Ischemic Conditioning in Necrotizing Enterocolitis: Feasibility and Safety Pilot Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 0 Months – 3 Months
• Healthy volunteers: —

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.

Conditions

• Enterocolitis, Necrotizing

Interventions

Type	Name	Description
PROCEDURE	Remote ischemic conditioning	An appropriately sized blood pressure cuff will be inflated around a limb (systolic blood pressure + 15 mmHg) for different periods of time (1 to up to 4 minutes), times (1 to up to 4 times) and consecutive days (1 to up to 2).

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-08-20
• Completion: 2019-08-20
• First posted: 2019-03-04
• Last updated: 2020-10-22

Locations

1 site across 1 country: Canada