Project Details

RIC-NEC Phase II Feasibility Randomized Controlled Trial: Remote Ischemic Conditioning in Necrotizing Enterocolitis

Agostino Pierro, MD

Summary

BACKGROUND: Necrotizing enterocolitis (NEC) is a devastating intestinal disease with high morbidity and mortality which remains a major unsolved clinical challenge in neonatology, in dire need for novel treatments. Remote ischemic conditioning (RIC) is a simple and non-invasive treatment strategy involving brief cycles of intermittent ischemia and reperfusion which protects distant organs against ischemic damage. Preclinical studies have demonstrated that RIC, given in the early stages of NEC, improves the intestinal damage due to NEC by enhancing intestinal blood flow. RIC has also been shown to be safe in preterm infants with NEC, producing no adverse complications. GAP: Our plan is to translate these exciting data into clinical evaluation. A multicenter Phase III RCT is necessary to prove the efficacy of RIC in NEC. However, before embarking upon the design of such trial, it is necessary to determine whether it is feasible to perform a muti-center masked RCT to evaluate RIC in neonates with NEC. HYPOTHESIS: The hypothesis of this study is that it is feasible to conduct a multicenter masked randomized controlled trial to evaluate RIC in infants with medical NEC. METHODS: The RIC-NEC trial is an interventional, prospective, randomized, controlled, masked, multicenter, feasibility Phase II trial. Participants are preterm infants with medical NEC being treated in level III neonatal intensive care units in 12 academic centers in Canada, The United States, The United Kingdom, Sweden, The Netherlands, and Spain. Neonates recruited will be randomized to RIC (intervention) or no RIC (control) and will continue to receive standard management of NEC. RESULTS: Pending. IMPACT: NEC is a devastating neonatal disease with severe implications for patients, their families, and the healthcare system. RIC is a simple bedside intervention that can be performed with minimal invasiveness and cost in preterm neonates with NEC, with potential to improve outcome. This Phase II RCT will provide the scientific foundations for a larger efficacy RCT, which may ultimately introduce a change in the paradigm of care and transform the treatment of neonates with NEC worldwide. Website Link: https://www.ric-necrct.org/ https://www.clinicaltrials.gov/ct2/show/NCT05279664