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Related Experiment Video

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Remote Limb Ischemic Preconditioning: A Neuroprotective Technique in Rodents
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Remote ischemic conditioning in necrotizing enterocolitis: study protocol of a multi-center phase II feasibility

Niloofar Ganji1,2, Bo Li1, Irfan Ahmad3

  • 1The Hospital for Sick Children, University of Toronto, 1526-555 University Ave, Toronto, ON, M5G 1X8, Canada.

Pediatric Surgery International
|March 16, 2022
PubMed
Summary

Remote ischemic conditioning (RIC) is a safe and feasible intervention for neonates with necrotizing enterocolitis (NEC). This study established an international consortium and protocol to inform future trials on RIC efficacy in early-stage NEC.

Keywords:
FeasibilityNecrotizing enterocolitisPhase IIRCTRandomized clinical trialRemote ischemic conditioning

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Area of Science:

  • Neonatal medicine
  • Surgical research
  • Cardiovascular research

Background:

  • Remote ischemic conditioning (RIC) involves brief limb ischemia-reperfusion cycles.
  • RIC has shown promise in experimental necrotizing enterocolitis (NEC) by improving intestinal microcirculation.
  • Previous studies indicated RIC is safe in neonates with NEC.

Purpose of the Study:

  • Evaluate the safety and feasibility of RIC in neonates with NEC.
  • Identify challenges in patient recruitment and retention for RIC trials.
  • Inform the design of a future Phase III Randomized Controlled Trial (RCT) to assess RIC efficacy.

Main Methods:

  • A Phase II multicenter, masked, feasibility RCT involving 12 international centers.
  • RIC intervention: four cycles of 4-min limb ischemia followed by 4-min reperfusion on two consecutive days.
  • Primary endpoint: feasibility and acceptability of recruitment, randomization within 24 hours of NEC diagnosis, masking, and intervention completion.

Main Results:

  • An international NEC consortium was formed with consensus on diagnostic criteria and trial protocol.
  • Inclusion criteria: gestational age < 33 weeks, weight ≥ 750g, medically treated NEC diagnosed within 24 hours.
  • Expected recruitment: 40% of eligible patients (78 neonates) over 30 months, analyzed using Bayesian methods.

Conclusions:

  • A novel NEC consortium has been established, generating data on NEC diagnosis and defining feasibility parameters for RIC.
  • This Phase II RCT provides crucial information for designing a future Phase III RCT.
  • The study will inform the evaluation of RIC's efficacy and safety in early-stage NEC.