Remote Ischemic Conditioning in Necrotizing Enterocolitis

NCT03860701 | Completed DMC

• 1 other identifier: REB1000061144
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Enterocolitis, Necrotizing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cutaneous injury

  1 days

• Persistent pain

  1 days

Interventions

Remote ischemic conditioning PROCEDURE

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).

Eligibility Criteria

• Age: 0 Months - 3 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants \< 36 weeks with NEC (stages I-III as per Bell's modified classification).

You may qualify if:

• 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.

You may not qualify if:

• Patients with major congenital anomalies
• No antecedent of limb ischemia/limb thrombotic events.
• No antecedent diagnosis of occlusive arterial or venous thrombosis
• Hemodynamic instability

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Zozaya C, Ganji N, Li B, Janssen Lok M, Lee C, Koike Y, Gauda E, Offringa M, Eaton S, Shah PS, Pierro A. Remote ischaemic conditioning in necrotising enterocolitis: a phase I feasibility and safety study. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):69-76. doi: 10.1136/archdischild-2022-324174. Epub 2022 Aug 8.

  PMID: 35940871 DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of The Division of General and Thoracic Surgery

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: March 4, 2019
• Study Start: December 17, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)