New Light-Based monitor could help protect newborn brains
NCT ID NCT05588960
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is observing brain oxygen levels in two groups of newborns at high risk of brain injury: full-term babies undergoing cooling treatment for oxygen deprivation, and extremely premature babies. Researchers use a non-invasive light sensor (near-infrared spectroscopy) to measure oxygen in brain tissue. The goal is to see how oxygen levels relate to brain injury and other health issues, which could improve monitoring and care in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors better understand how to monitor brain health in vulnerable newborns, potentially leading to improved care and early detection of brain injury.
- What could go wrong
- This is an observational study, not a treatment trial. It does not test a new therapy, so it cannot directly improve outcomes. Results may not apply to all newborns or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will recruit a cohort of term/near-term and preterm infants who admitted to the neonatal intensive care unit at the Simpson Centre for Reproductive Health (Edinburgh, NHS Lothian, UK) and are at risk of brain injury or brain dysmaturation. Potential participants will be identified through admission to the neonatal intensive care unit. Once eligibility is confirmed, a member of the research team will approach parents to discuss the study and invite the baby to enter the study. Participants will be recruited over a 2 year period. Preterm infants may be enrolled in more than one sub-study should their parents provide informed consent for this.
- Ages
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1 day to 14 weeks
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA, United Kingdom
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Other studies related to the condition(s) this trial covers.
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