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RIC-NEC Randomized Controlled Trial
NCT05279664 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Remote ischemic conditioning (RIC) + Standard of Care for NEC
- OTHER Standard of Care for NEC
Study Locations (4)
Ontario
- Sunnybrook Health Sciences Center — Toronto
- Mount Sinai Hospital — Toronto
- The Hospital for Sick Children — Toronto
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2026-03-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05279664
The ClinicalTrials.gov registry entry for NCT05279664 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Hospital for Sick Children, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Necrotizing Enterocolitis appearing as the primary indexed condition, and to 2 interventions — of which Remote ischemic conditioning (RIC) + Standard of Care for NEC is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05279664 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Ontario, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05279664 about?
NCT05279664 is a clinical study titled "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 c...
What is the current status of trial NCT05279664?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2023-02-09. Estimated completion is 2026-03-18.
What conditions does trial NCT05279664 study?
This clinical trial studies the following conditions: Necrotizing Enterocolitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05279664?
The interventions under investigation include: Remote ischemic conditioning (RIC) + Standard of Care for NEC (OTHER), Standard of Care for NEC (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05279664?
This trial is sponsored by The Hospital for Sick Children, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05279664 being conducted?
This trial has 4 study locations across Ohio, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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