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 range

1 Day – 14 Weeks

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is actively enrolling but no longer recruiting new participants, is there any chance my baby could still be considered for enrollment, or are there similar observational studies on cerebral oxygenation that we might look into instead?
2This study seems to include both full-term newborns with hypoxic ischemic encephalopathy and premature babies — which group would my baby most likely fall into, and how does that affect what would actually be measured or done during the study?
3Since this is listed as Phase NA, which often means it's an observational or device study rather than a treatment trial, can you explain whether participating would change my baby's care at all, or would it mainly involve monitoring like sensors measuring oxygen levels in the brain?
4The study includes a skin-to-skin sub-study for premature infants — if my baby qualifies for that part, what would skin-to-skin contact look like in practice given my baby's current condition, and are there any risks to consider?
5If my baby has been diagnosed with hypoxic ischemic encephalopathy, would you recommend focusing on established treatments like therapeutic cooling first, and how would participating in this observational study fit alongside that standard care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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