Using remote ischemic conditioning to treat necrotizing enterocolitis in neonates

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

This study is testing if a new treatment called remote ischemic conditioning can help newborns with necrotizing enterocolitis feel better when combined with standard care.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 0 Weeks and up
• Sex: All
• Sponsor: The Hospital for Sick Children (other)
• Locations: 4 sites (Cincinnati, Ohio and 3 other locations)
• Trial ID: NCT05279664 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of remote ischemic conditioning (RIC) as a treatment for necrotizing enterocolitis (NEC) in preterm and term neonates. The study is designed as a Phase II multicenter, masked, randomized controlled trial, where participants will receive either RIC combined with standard care or standard care alone. RIC involves applying brief cycles of non-lethal ischemia and reperfusion to a limb, which may protect the intestines from ischemic damage associated with NEC. The trial aims to assess the feasibility and safety of this innovative approach in a vulnerable patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm neonates weighing at least 750 grams who have been diagnosed with medical NEC within the last 24 hours.

Not a fit: Patients who have indications for surgical intervention or have previously experienced episodes of NEC may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality and improve long-term outcomes for neonates suffering from necrotizing enterocolitis.

How similar studies have performed: While remote ischemic conditioning has shown promise in experimental settings, this approach is novel in the context of treating necrotizing enterocolitis in neonates.

Eligibility criteria

Inclusion Criteria:

1. Preterm neonates with all gestational age at birth.
2. Current weight ≥750 g
3. 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).
4. NEC diagnosis established within the previous 24 hours.

Exclusion Criteria:

1. 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
2. Previous episodes of NEC
3. Diagnosis of NEC established \>24 hours ago
4. Major congenital heart disease which needs surgical repair
5. Antecedent limb ischemia/limb thrombotic events, occlusive arterial or venous thrombosis
6. Associated gastrointestinal anomalies including gastroschisis or congenital diaphragmatic hernia.

Where this trial is running

Cincinnati, Ohio and 3 other locations

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

Study contacts

• Principal investigator: Agostino Pierro, OBE, MD — The Hospital for Sick Children
• Study coordinator: Agostino Pierro, OBE, MD, FRCS, FAAP

Conditions: Necrotizing Enterocolitis, remote ischemic conditioning, prematurity