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ACTIVE NOT RECRUITING

NCT05588960

Investigating Cerebral Oxygenation in the Newborn

Sponsor: University of Edinburgh

View on ClinicalTrials.gov

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.

Official title: Investigating Cerebral Oxygenation in the Newborn: An Observational Study Investigating Cerebral Oxygenation in Newborn Infants at High Risk of Brain Injury

Key Details

Gender

All

Age Range

1 Day - 14 Weeks

Study Type

OBSERVATIONAL

Enrollment

Start Date

2023-07-21

Completion Date

2027-05

Last Updated

2026-03-17

Healthy Volunteers

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.

TERM/NEAR-TERM GROUP INCLUSION CRITERIA: 1. Infants born at greater than or equal to 34 weeks gestational age undergoing therapeutic hypothermia as an intervention for moderate to severe neonatal encephalopathy. These infants will meet the following criteria for treatment: * Evidence of intrapartum asphyxia as defined by ANY of the following features: Apgar score of 5 or less at 10 minutes after birth; ongoing need for endotracheal or mask ventilation at 10 minutes after birth; pH \<7.00 in cord or baby sample within 60 minutes of birth; base deficit greater than or equal to 16mmol/L in cord or baby sample within 60 minutes of birth. * Moderate or severe encephalopathy, including ALL of the following criteria OR altered consciousness plus seizures: altered consciousness (reduced or absent response to stimulation); abnormal primitive reflexes (weak or absent suck or Moro response); abnormal tone (hypotonia, flaccid). 2. Signed parental consent form. EXCLUSION CRITERIA: 1. Lack of signed parental consent form and/or parental decision not to participate. 2. Infants with life threatening congenital malformations. 3. Infants with encephalopathy caused by differing pathology to hypoxia-ischaemia. PRETERM GROUP INCLUSION CRITERIA: 1. Infants born at less than 28 weeks completed gestation. 2. Signed informed parental consent form for each specific section/sub-study. 3. For skin-to-skin sub-study: considered by responsible clinical team to be eligible for skin-to-skin care as per usual local practice. 4. For BPD sub-study: infants born at less than 28 weeks gestational age surviving to 36 weeks corrected gestational age. Infants with and without a diagnosis of BPD will be recruited to allow for comparison of cerebral oxygenation between these groups. EXCLUSION CRITERIA: 1. Lack of signed parental consent form and/or parental decision not to participate. 2. Decision not to provide active (survival focussed) neonatal management. 3. Infants with life threatening congenital malformation. 4. Infants in whom there is a particularly high level of concerns regarding skin fragility or loss of skin integrity resulting in application of NIRS probe being contraindicated. 5. Infants who are transferred back to local centres will be excluded from the BPD sub-study if transferred back to local centre prior to 36 weeks corrected gestational age and from follow-up data collection due to difficulties achieving acquisition of full data set for babies followed up in health boards outwith NHS Lothian.

Locations (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom