Active — Not RecruitingNot Applicable

Investigating Cerebral Oxygenation in the Newborn

United Kingdom99 participantsStarted 2023-07-21

Plain-language 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.

Who can participate

Age range1 Day – 14 Weeks

SexALL

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Inclusion criteria

✓. 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:
✓. Signed parental consent form.

Exclusion criteria

✕. Lack of signed parental consent form and/or parental decision not to participate.
✕. Infants with life threatening congenital malformations.
✕. Infants with encephalopathy caused by differing pathology to hypoxia-ischaemia.
✕. Infants born at less than 28 weeks completed gestation.
✕. Signed informed parental consent form for each specific section/sub-study.
✕. For skin-to-skin sub-study: considered by responsible clinical team to be eligible for skin-to-skin care as per usual local practice.
✕. 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.

What they're measuring

Term/Near-Term Group: Primary Outcome 1

Timeframe: Birth-15 days

Term/Near-Term Group: Primary Outcome 2

Timeframe: Birth-5 days

Preterm Group - Skin-to-skin sub-study: Primary Outcomes

Timeframe: 2.5 hours

Preterm Group - BPD sub-study: Primary Outcomes

Timeframe: 24 hours

Trial details

NCT IDNCT05588960

SponsorUniversity of Edinburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Hypoxic Ischemic Encephalopathy of Newborn trials