Remote ischaemic conditioning in necrotising enterocolitis: a phase I feasibility and safety study

• Published in: Archives of Disease in Childhood - Fetal and Neonatal Edition Vol. 108; no. 1; pp. 69 - 76
• Main Authors: Zozaya, Carlos, Ganji, Niloofar, Li, Bo, Janssen Lok, Maarten, Lee, Carol, Koike, Yuhki, Gauda, Estelle, Offringa, Martin, Eaton, Simon, Shah, Prakeshkumar S, Pierro, Agostino
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health 01.01.2023; BMJ; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Birth weight; Child; Enterocolitis, Necrotizing; Feasibility Studies; gastroenterology; Gastrointestinal diseases; Gestational age; Humans; Infant, Newborn; Infant, Newborn, Diseases; Infant, Premature; Infants; Intensive care; Ischemia; Mortality; Necrosis; Neonatal care; Neonates; neonatology; Newborn babies; Original Research; Oxygen saturation; Pain; Pediatrics; Pilot Projects; Population; Premature babies; Pulse oximetry; Safety; Thoracic surgery; Urine; United States > US; neonatology; gastroenterology
• ISSN: 1359-2998; 1468-2052; 1468-2052
• DOI: 10.1136/archdischild-2022-324174

ObjectiveRemote ischaemic conditioning (RIC) improves the outcome of experimental necrotising enterocolitis (NEC) by preserving intestinal microcirculation. The feasibility and safety of RIC in preterm infants with NEC are unknown. The study aimed to assess the feasibility and safety of RIC in preterm infants with suspected or confirmed NEC.DesignPhase I non-randomised pilot study conducted in three steps: step A to determine the safe duration of limb ischaemia (up to 4 min); step B to assess the safety of 4 repeated cycles of ischaemia-reperfusion at the maximum tolerated duration of ischaemia determined in step A; step C to assess the safety of applying 4 cycles of ischaemia-reperfusion on two consecutive days.SettingLevel III neonatal intensive care unit, The Hospital for Sick Children (Toronto, Canada).PatientsFifteen preterm infants born between 22 and 33 weeks gestational age.InterventionFour cycles of ischaemia (varying duration) applied to the limb via a manual sphygmomanometer, followed by reperfusion (4 min) and rest (5 min), repeated on two consecutive days.OutcomesThe primary outcomes were (1) feasibility defined as RIC being performed as planned in the protocol, and (2) safety defined as perfusion returning to baseline within 4 min after cuff deflation.ResultsFour cycles/day of limb ischaemia (4 min) followed by reperfusion (4 min) and a 5 min gap, repeated on two consecutive days was feasible and safe in all neonates with suspected or confirmed NEC.ConclusionsThis study is pivotal for designing a future randomised controlled trial to assess the efficacy of RIC in preterm infants with NEC.Trial registration number NCT03860701.