RIC-NEC Phase II RCT
Research type
Research Study
Full title
RIC-NEC Phase II Feasibility Randomized Controlled Trial: Remote Ischemic Conditioning in Necrotizing Enterocolitis
IRAS ID
312348
Contact name
Nigel Hall
Contact email
Sponsor organisation
The Hospital for Sick Children
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Necrotizing enterocolitis (NEC) is a serious intestinal disease of preterm infants with adverse morbidity and high mortality (30-50% in advanced cases), and in need of precision treatment. NEC is associated with impaired intestinal microcirculation.
Remote ischemic conditioning (RIC) is a simple maneuver involving brief cycles of ischemia-reperfusion in the neonate’s limb. RIC administered in early-stage experimental NEC, decreased intestinal injury and prolonged survival by enhancing intestinal microcirculation; highlighting a potential for RIC as a novel treatment for early-stage NEC. A Phase I pilot safety study was recently completed at the Hospital for Sick Children (Toronto, CA) and demonstrated that RIC is safe in neonates with NEC. The objective of this study is to perform a Phase II multicentre masked feasibility randomized controlled trial (RCT) that will identify unexpected challenges in recruitment, retainment, delivery and masking of intervention and measurement of clinical outcomes and will inform the successful conduct of a future efficacy Phase III RCT.
This study will be conducted at 12 centres in six countries (Canada, USA, Sweden, The Netherlands, UK, and Spain). Neonates with gestational age<33, weight ≥750 grams, and confirmed diagnosis of medical NEC established within 24-hours will be included. We expect to recruit and randomize 78 patients (39/group) in 30 months. Neonates will be randomized to one of two arms: RIC (intervention) or no RIC (control) and will continue to receive standard management of NEC. RIC will be performed by trained research personnel using a blood pressure cuff and will consist of 4 cycles of limb ischemia (5-min via cuff inflation) followed by reperfusion (5-min via deflation), repeated on two consecutive days post-randomization. The primary endpoint is the feasibility and acceptability of recruiting and randomizing neonates within 24 hours from NEC diagnosis as well as masking and completing the RIC intervention.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0115
Date of REC Opinion
16 May 2024
REC opinion
Further Information Favourable Opinion