Remote Ischemic Conditioning in Necrotizing Enterocolitis

Completed

• Conditions: Enterocolitis, Necrotizing

• Registration Number: NCT03860701
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2018-12-17
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Limb perfusion after Remote Ischemic Conditioning	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 Outcome Measures

Name	Time	Method
Cutaneous injury	1 days	Defined as new-onset skin breakdown, bruising, ecchymosis or petechiae.
Persistent pain	1 days	Pain measured according to the premature infant pain profile (PIPP) scores (range 0-21). Pain scores will be obtained immediately before (baseline) and 6 hours after RIC. Persistent pain will be defined as a PIPP score higher than the baseline score.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada