Remote ischemic conditioning in necrotizing enterocolitis
| Autor: | Niloofar Ganji, Bo Li, Irfan Ahmad, Alan Daneman, Poorva Deshpande, Vijay Dhar, Simon Eaton, Ricardo Faingold, Estelle B. Gauda, Nigel Hall, Salhab el Helou, Mustafa H. Kabeer, Jae H. Kim, Alice King, Michael H. Livingston, Eugene Ng, Martin Offringa, Elena Palleri, Mark Walton, David E. Wesson, Tomas Wester, Rene M. H. Wijnen, Andrew Willan, Rosanna Yankanah, Carlos Zozaya, Prakesh S. Shah, Agostino Pierro |
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| Přispěvatelé: | Pediatric Surgery |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Clinical Trials
Phase I as Topic Infant Newborn Infant Bayes Theorem General Medicine Intestines Clinical Trials Phase II as Topic Treatment Outcome Enterocolitis Necrotizing Ischemia Pediatrics Perinatology and Child Health Feasibility Studies Humans Multicenter Studies as Topic Surgery Randomized Controlled Trials as Topic |
| Zdroj: | Pediatric Surgery International, 38(5), 679-694. Springer-Verlag |
| ISSN: | 1437-9813 0179-0358 |
| Popis: | Purpose: Remote ischemic conditioning (RIC) is a maneuver involving brief cycles of ischemia reperfusion in an individual’s limb. In the early stage of experimental NEC, RIC decreased intestinal injury and prolonged survival by counteracting the derangements in intestinal microcirculation. A single-center phase I study demonstrated that the performance of RIC was safe in neonates with NEC. The aim of this phase II RCT was to evaluate the safety and feasibility of RIC, to identify challenges in recruitment, retainment, and to inform a phase III RCT to evaluate efficacy. Methods: RIC will be performed by trained research personnel and will consist of four cycles of limb ischemia (4-min via cuff inflation) followed by reperfusion (4-min via cuff deflation), repeated on two consecutive days post randomization. The primary endpoint of this RCT is feasibility and acceptability of recruiting and randomizing neonates within 24 h from NEC diagnosis as well as masking and completing the RIC intervention. Results: We created a novel international consortium for this trial and created a consensus on the diagnostic criteria for NEC and protocol for the trial. The phase II multicenter-masked feasibility RCT will be conducted at 12 centers in Canada, USA, Sweden, The Netherlands, UK, and Spain. The inclusion criteria are: gestational age < 33 weeks, weight ≥ 750 g, NEC receiving medical treatment, and diagnosis established within previous 24 h. Neonates will be randomized to RIC (intervention) or no-RIC (control) and will continue to receive standard management of NEC. We expect to recruit and randomize 40% of eligible patients in the collaborating centers (78 patients; 39/arm) in 30 months. Bayesian methods will be used to combine uninformative prior distributions with the corresponding observed proportions from this trial to determine posterior distributions for parameters of feasibility. Conclusions: The newly established NEC consortium has generated novel data on NEC diagnosis and defined the feasibility parameters for the introduction of a novel treatment in NEC. This phase II RCT will inform a future phase III RCT to evaluate the efficacy and safety of RIC in early-stage NEC. |
| Databáze: | OpenAIRE |
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