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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Other Locations
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Center
RECRUITING
Toronto
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
Agostino Pierro, OBE, MD, FRCS, FAAP
agostino.pierro@sickkids.ca
4168137654
Backup
Niloofar Ganji, BSc, MSc
niloofar.ganji@sickkids.ca
6478702781
Time Frame
Start Date: 2023-02-09
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 78
Treatments
Experimental: Intervention (RIC + standard of care for NEC)
Neonates randomized to the intervention arm will receive RIC and will continue to receive the standard of care for NEC.
Sham_comparator: Control (Standard of care for NEC)
Neonates randomized to the control arm will receive the standard of care for NEC. The research fellow or nurse responsible for performing RIC will be performing sham inflation/deflation of the blood pressure cuff connected to a dummy arm to mimic the noise of the cuff for neonates in the control arm.
Sponsors
Collaborators: Karolinska University Hospital, Hospital Universitario La Paz, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Orange County, Sunnybrook Health Sciences Centre, Shanghai Children's Hospital, Sophia Kindergeneeskunde, Thrasher Research Fund, McMaster Children's Hospital, Mount Sinai Hospital, Canada, UCL Great Ormond Street Institute of Child Health, University of Southampton, Xiamen Children's Hospital, Fujian of China
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov