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NCT05279664 · ClinicalTrials.gov registry record · Phase 2
RIC-NEC Randomized Controlled Trial
A Phase 2 study of Necrotizing Enterocolitis, sponsored by The Hospital for Sick Children.
- Active
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 4
- Study locations
NCT05279664: Active Phase 2 study of Necrotizing Enterocolitis, sponsored by The Hospital for Sick Children.
NCT05279664 is a Phase 2 study of Necrotizing Enterocolitis that is active but no longer recruiting, run by The Hospital for Sick Children. The registered enrollment target is 78 participants, below the 308-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (75% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05279664, a Phase 2 study of Necrotizing Enterocolitis, is active but no longer recruiting, sponsored by The Hospital for Sick Children.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
The investigators will determine the proportion (% total) of screened patients who meet the inclusion criteria and do not meet the exclusion criteria and are therefore eligible for enrollment in this study.
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 |
What the registry record for NCT05279664 still lists
NCT05279664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 308-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (75% lower).
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.
NCT05279664 reports a single indexed study location in Ontario, Ohio.
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.
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).
Who is sponsoring clinical trial NCT05279664?
This trial is sponsored by The Hospital for Sick Children, which has 23 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05279664's enrollment target sits among peer trials
78 10th of 14 higher than 5 of 14 other Necrotizing Enterocolitis trials
participants (enrollment target), bucketed by value
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