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

OBJECTIVE

Remote 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.

DESIGN

Phase 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.

SETTING

Level III neonatal intensive care unit, The Hospital for Sick Children (Toronto, Canada).

PATIENTS

Fifteen preterm infants born between 22 and 33 weeks gestational age.

INTERVENTION

Four 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.

OUTCOMES

The 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.

RESULTS

Four 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.

CONCLUSIONS

This 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.