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ICON
Sponsor study identifier
observational
99
1 country
1
Study Start
July 21, 2023
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2022
Actual (reported)October 20, 2022
Actual (reported)July 21, 2023
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Term/Near-Term Group: Primary Outcome 1
Mean cerebral oxygenation calculated over 1 hour periods at pre-defined time points during therapeutic hypothermia and after completion of rewarming compared to presence/absence of brain injury on magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) performed between 5-15 days after birth. Brain injury will be defined as: * NICHD NRN MRI score of ≥2A * Lactate to n-acetylaspartate peak ratio of \>0.39 on MRS
Birth-15 days
Term/Near-Term Group: Primary Outcome 2
Maximum change in cerebral oxygenation from baseline occurring during electrical seizures detected on aEEG and cerebral hypoxic burden (expressed in % hours) for any periods of cerebral hypoxia associated with seizures.
Birth-5 days
Preterm Group - Skin-to-skin sub-study: Primary Outcomes
Cohort of term/near-term infants undergoing therapeutic hypothermia for moderate to severe HIE. Data collected from NIRS monitoring and other assessments/investigations that are part of routine clinical care. There are no additional study specific interventions or exposures for this group.
Cohort of infants born at less than 28 weeks gestational age. Data collected from NIRS monitoring, other physiological monitoring, cranial ultrasound scans and neurodevelopmental follow up assessments that are part of routine clinical care. This data will be analysed to fulfil secondary study objectives. There are no additional study specific interventions or exposures for this group.
Cohort of infants born at less than 28 weeks gestational age who are considered by clinical team to be suitable to undergo period of skin-to-skin care. Participants will undergo additional research-specific period(s) of NIRS monitoring before, during and after period(s) of skin-to-skin care. Participants with and without severe brain injury on cranial ultrasound will be recruited to allow comparison.
Cohort of infants born at less than 28 weeks gestational age who will undergo an additional research-specific period of NIRS monitoring at 36 weeks corrected gestational age. Participants with and without bronchopulmonary dysplasia (BPD) will be recruited to allow comparison.
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.
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.
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA, United Kingdom
Helen L Turner, MBChB (Hons)
University of Edinburgh/NHS Lothian
First Submitted
October 17, 2022
First Posted
October 20, 2022
Study Start
July 21, 2023
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in mean cerebral oxygenation (calculated every 5 minutes) and in variability of cerebral oxygenation during a period of skin-to-skin care compared to periods of incubator care before (pre-intervention) and after (post-intervention) skin-to-skin care. These measures will be compared in infants with and without severe brain injury detected on routine cranial ultrasound scans. Severe brain injury will be defined as: * Grade III or IV intraventricular haemorrhage * Cystic periventricular leucomalacia
2.5 hours
Preterm Group - BPD sub-study: Primary Outcomes
Mean cerebral oxygenation measured over a 24-hour period at 36 weeks corrected gestational age and cerebral hypoxic burden (expressed in % hours) of any periods of cerebral hypoxia over this 24-hour epoch. These measures will be compared in infants with and without a diagnosis of bronchopulmonary dysplasia. Bronchopulmonary dysplasia will be defined as the need for any additional respiratory support (including supplementary oxygen) at 36 weeks corrected gestational age.
24 hours
Term/Near-Term Group: Secondary Outcome 1
Birth-12 to 15 weeks
Term/Near-Term Group: Secondary Outcome 2
2 years
Preterm Group: Secondary Outcome 1
Birth-max 14 weeks
Preterm Group: Secondary Outcome 2
Birth-12 to 15 weeks
Preterm Group: Secondary Outcome 3
2 years
Masimo O3 neonatal sensor will be applied: ▪ For 24 hours once the participant reaches 36 weeks corrected gestational age.
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Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 17, 2026
Record last verified: 2026-03
Following completion of the study and after primary publications by the study team, all collected anonymous IPD will be shared in line with the FAIR principles (findable, accessible, interoperable and resuable). Parents will have the option to opt out of their child's anonymous data being shared for the purposes of further research at the time of consent. Data will be made available through DataShare, a data respository run by The University of Edinburgh. This will be maintained indefinitely by the University of Edinburgh Data Library staff. Associated metadata will be created in Pure (the University's Current Research Information System) which will be linked to the dataset in DataShare.
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Source: ClinicalTrials.gov.
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