Investigating Cerebral Oxygenation in the Newborn

Active, not recruitingOBSERVATIONAL
Enrollment

99

Participants

Timeline

Start Date

July 21, 2023

Primary Completion Date

January 31, 2027

Study Completion Date

May 31, 2027

Conditions
Hypoxic Ischemic Encephalopathy of NewbornNeonatal EncephalopathyPremature Infant Disease
Interventions
DEVICE

Near-infrared spectroscopy monitoring (Masimo O3 Regional Oximeter with Neonatal Sensor)

"Masimo O3 neonatal sensor will be applied:~* At least 30 minutes before a period of skin-to-skin care with a caregiver commences (baseline condition).~* Throughout the period of skin-to-skin care, which should continue for a minimum of 1 hour.~* For at least 1 hour after the participant is returned to their incubator (post-intervention condition).~The protocol accounts for a 30 minute washout period between each study epoch. Therefore, at least 30 minutes of study data will be collected for each epoch."

DEVICE

Near-infrared spectroscopy monitoring (Masimo O3 Regional Oximeter with Neonatal Sensor)

"Masimo O3 neonatal sensor will be applied:~▪ For 24 hours once the participant reaches 36 weeks corrected gestational age."

Trial Locations (1)

EH16 4SA

Royal Infirmary of Edinburgh, Edinburgh

All Listed Sponsors
collaborator

NHS Lothian

OTHER_GOV

collaborator

Prism Training and Consultancy

UNKNOWN

collaborator

Simpsons Special Care Babies

UNKNOWN

lead

University of Edinburgh

OTHER