Status:
RECRUITING
RIC-NEC Randomized Controlled Trial
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Thrasher Research Fund
Mount Sinai Hospital, Canada
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 ...
Detailed Description
Background: 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 pediat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05279664
Start Date
February 9 2023
End Date
May 1 2027
Last Update
July 25 2025
Active Locations (4)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
2
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4Y 3M5
3
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
4
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8