78
Participants
Start Date
February 9, 2023
Primary Completion Date
February 1, 2027
Study Completion Date
May 1, 2027
Remote ischemic conditioning (RIC) + Standard of Care for NEC
RIC will consist of 4 cycles of limb ischemia (5 min) followed by reperfusion (5 min), repeated on two consecutive days. An appropriately sized blood pressure cuff (covering 2/3 of the distance between the shoulder and the elbow) will be applied by a trained research fellow or nurse to an arm (or leg if the arm is not available because of medical reasons such as central line insertion). The systolic blood pressure will be measured before the first RIC cycle using a different cuff of same size connected to a monitor. During ischemia time, the cuff will be inflated to a pressure of 15 mmHg above the child's systolic pressure. Neonates in this arm will continue to receive standard of care for NEC.
Standard of Care for NEC
Neonates in this arm (i.e. the control arm) will receive standard of care for NEC.
RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
RECRUITING
Sunnybrook Health Sciences Center, Toronto
RECRUITING
Mount Sinai Hospital, Toronto
RECRUITING
The Hospital for Sick Children, Toronto
Thrasher Research Fund
OTHER
Mount Sinai Hospital, Canada
OTHER
Sunnybrook Health Sciences Centre
OTHER
McMaster Children's Hospital
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Children's Hospital of Orange County
OTHER
Karolinska University Hospital
OTHER
Sophia Kindergeneeskunde
OTHER
UCL Great Ormond Street Institute of Child Health
OTHER
Hospital Universitario La Paz
OTHER
University of Southampton
OTHER
Xiamen Children's Hospital, Fujian of China
OTHER
Shanghai Children's Hospital
OTHER
The Hospital for Sick Children
OTHER