Remote Ischemic Conditioning in Necrotizing Enterocolitis

Enterocolitis, Necrotizing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860701
• Other study ID #: REB1000061144
• Status: Completed
• Start date: December 17, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: October 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing

Intervention

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).

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limb perfusion after Remote Ischemic Conditioning	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).	1 days
Secondary	Cutaneous injury	Defined as new-onset skin breakdown, bruising, ecchymosis or petechiae.	1 days
Secondary	Persistent pain	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.	1 days