Remote ischaemic conditioning in necrotising enterocolitis: a phase I feasibility and safety study.
Arch Dis Child Fetal Neonatal Ed
; 108(1): 69-76, 2023 Jan.
Article
en En
| MEDLINE
| ID: mdl-35940871
ABSTRACT
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 threesteps:
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.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Enterocolitis Necrotizante
/
Enfermedades del Recién Nacido
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Arch Dis Child Fetal Neonatal Ed
Asunto de la revista:
PEDIATRIA
/
PERINATOLOGIA
Año:
2023
Tipo del documento:
Article