RIC-NEC Randomized Controlled Trial

Necrotizing enterocolitis (NEC) is a serious intestinal disease of preterm and term neonates which remains a major cause of intestinal failure, and an unsolved clinical challenge in pediatrics. While overall mortality of preterm infants continues to decrease due to improvements in general neonatal care, mortality caused by NEC remains high (up to 30-50%) and survivors suffer from reduced quality of life, and long-term disabilities such as debilitating complications of intestinal failure, poor growth and neurodevelopmental delay. Besides prevention, there have been hardly any innovations in the treatment of NEC which underwent trial evaluation. NEC pathogenesis is multifactorial, but bowel ischemia is known to play an essential role in the development of NEC. Remote ischemic conditioning (RIC) is a therapeutic maneuver that involves brief cycles of non-lethal ischemia and reperfusion applied to a limb, which protects distant organs (such as the intestine) from ischemic damage. The investigators have shown that in preclinical models of NEC, RIC effectively reduces intestinal damage and prolongs survival. The investigators have also demonstrated the safety of RIC in preterm neonates with NEC. Before the investigators can evaluate the effectiveness of RIC in treating neonates with NEC in a Phase III randomized clinical trial (RCT), a Phase II Feasibility RCT must be conducted to evaluate issues related to the enrollment and randomization of neonates, masking of the RIC intervention, and measurement of clinical outcomes. The investigators hypothesize that it is feasible to conduct a multicenter RCT to evaluate RIC during the management of neonates with medical NEC.

NCT Number	NCT05279664
Lead Sponsor	The Hospital for Sick Children Collaborators: Thrasher Research Fund, Mount Sinai Hospital, Canada, Sunnybrook Health Sciences Centre, McMaster Children's Hospital, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Orange County, Karolinska University Hospital, Sophia Kindergeneeskunde, UCL Great Ormond Street Institute of Child Health, Hospital Universitario La Paz, University of Southampton, Xiamen Children's Hospital, Fujian of China, Shanghai Children's Hospital
Conditions	Necrotizing Enterocolitis
Enrollment	78 participants
Start Date	2023-02-09
Primary Completion	2025-12-20 (estimated)
Study Completion	2026-03-18 (estimated)
Updated on ClinicalTrials.gov	2026-02-03