Investigating Cerebral Oxygenation in the Newborn

Summary

The goal of this single centre observational study is to use near-infrared spectroscopy (NIRS) monitoring to investigate cerebral oxygenation in two groups of newborn infants who are at high risk of brain injury. The NIRS monitor used in this study will be the Masimo O3 regional oximeter with neonatal sensors.

Near-infrared spectroscopy (NIRS) monitoring uses near-infrared light to measure oxygen levels in the brain tissue (cerebral oxygenation). It provides information about blood flow to the brain and the balance between oxygen supply and demand in the brain tissue. It is non-invasive, safe and used routinely to monitor term and premature babies in the neonatal intensive care unit (NICU).

This study will recruit two groups of infants admitted to the NICU who are at risk of brain injury in the newborn period, namely:

* Term and near-term babies who are undergoing cooling treatment (therapeutic hypothermia) for moderate to severe hypoxic ischaemic encephalopathy (HIE).
* Preterm babies who are born extremely prematurely (before 28 weeks of pregnancy).

In the term/near-term group, the primary aims of the study are:

* To investigate if cerebral oxygenation during and after cooling treatment relates to markers of brain injury detected on detailed brain scans (MRI and MRS scans).
* To describe any changes in cerebral oxygenation which occur during and after seizures (fits) in babies undergoing cooling treatment.

In the preterm group, the primary aims of the study are:

* To investigate if any changes in cerebral oxygenation occurring during skin-to-skin care are different in premature babies with brain injury (bleeding or cysts in the brain seen on ultrasound scan) compared to babies without these changes.
* To investigate if cerebral oxygenation at 36 weeks corrected gestational age differs in babies with bronchopulmonary dysplasia (BDP, a chronic lung disease of prematurity) compared to babies without BPD.

Conditions

• Hypoxic Ischemic Encephalopathy of Newborn
• Neonatal Encephalopathy
• Premature 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.

Sponsors & Collaborators

• NHS Lothian

  collaborator OTHER_GOV

• Prism Training and Consultancy

  collaborator UNKNOWN

• Simpsons Special Care Babies

  collaborator UNKNOWN

• University of Edinburgh

  lead OTHER

Principal Investigators

• Helen L Turner, MBChB (Hons) · University of Edinburgh/NHS Lothian

Eligibility

Min Age

1 Day

Max Age

14 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-21

Primary Completion

2027-01-31

Completion

2027-05-31

Countries

• United Kingdom

Study Locations