RIC-NEC Randomized Controlled Trial

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Necrotizing Enterocolitis

In brief

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.

Key facts

Study ID

NCT05279664

Run by

The Hospital for Sick Children

People needed

78

Starts

2023-02-09

Expected to finish

2026-03-18

Last updated by the study team

2026-02-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All gestational age at birth.
• Current weight ≥600 g
• Confirmed diagnosis of "medical" NEC based on the joint opinion of two attending experts in the field (two neonatologists or one neonatologist and one pediatric surgeon).
• NEC diagnosis established within the previous 24 hours.

You may not qualify if…

• Indication for surgery in the joint opinion of the attending neonatologist and pediatric surgeon (i.e. surgical NEC). This diagnosis is based on the presence of pneumoperitoneum in the abdominal radiograph and/or failure of medical treatment for NEC
• Previous episodes of NEC
• Diagnosis of NEC established >24 hours ago
• Major congenital heart disease which needs surgical repair
• Antecedent limb ischemia/limb thrombotic events, occlusive arterial or venous thrombosis
• Associated gastrointestinal anomalies including gastroschisis or congenital diaphragmatic hernia.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Sunnybrook Health Sciences Center — Toronto, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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