RIC-NEC Randomized Controlled Trial (NCT05279664)
RIC-NEC Phase II Feasibility Randomized Controlled Trial: Remote Ischemic Conditioning in Necrotizing Enterocolitis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
Age range: 0 Weeks
🧪 Interventions in This Study
- Remote ischemic conditioning (RIC) + Standard of Care for NEC (OTHER)
- Standard of Care for NEC (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Sunnybrook Health Sciences Center — Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Necrotizing Enterocolitis
- IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study — Tucson, Arizona
- Early Predictors of Necrotizing Enterocolitis in Neonates — Columbus, Ohio
- A Cohort Study of the Intestinal Microbiota of Premature Infants — Sacramento, California
- WithHolding Enteral Feeds Around Blood Transfusion (International) — Halifax, Nova Scotia
- Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC) — Little Rock, Arkansas
Explore by condition: All Necrotizing Enterocolitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.