An interventional study of Xenon gas in Hypoxic Ischaemic Encephalopathy, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 1 Hour to 12 Hours. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Imperial College London · Not applicable, Interventional, and Treatment
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Among 16 studies in Hypoxia-Ischemia, Brain with a site in United Kingdom — 3 open to participants now, 5 under way, none of them phase 3. Hypoxia-Ischemia, Brain · United Kingdom.
Among the 16 studies in Hypoxia-Ischemia, Brain with a site in United Kingdom, this one is one of 3 that started in 2012, is one of 5 with no phase, and was the 2nd registered.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
Browse Hypoxia-Ischemia, Brain studies →3 of the 16 studies in Hypoxia-Ischemia, Brain with a site in United Kingdom are open now. Recruiting first, the newest first:
Medway NHS Foundation Trust · Sites in United Kingdom
Ages 16+ · Women only · Healthy volunteers
University of Michigan · Sites in United Kingdom, United States, Australia and 2 more countries
Ages 2 days–17 yrs
Birmingham Women's NHS Foundation Trust · Sites in United Kingdom
Ages 0 min–8 wk · Healthy volunteers
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 60 Hypoxia-Ischemia, Brain studies recruiting now, 21 (35%) set no upper age limit and 37 (62%) stop at 75 or younger; 46 take children under 18; 7 take healthy volunteers.
This study: 1 Hour to 12 Hours · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3
First in 2009; this study’s year is marked. 3 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 92 is above the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Median enrollment 53 across the 8 interventional studies, 195 across the 8 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
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None of the 16 has an industry lead sponsor. The 10 most frequent:
Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Imperial College London has 3 studies filed under Hypoxia-Ischemia, Brain — fewer than ten, so there is no comparison to draw.
1 of the studies in Hypoxia-Ischemia, Brain with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05588960University of EdinburghInvestigating Cerebral Oxygenation in the Newborn | 2027-01 |
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Among the 16 studies in Hypoxia-Ischemia, Brain with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a randomised controlled trial in newborn infants with perinatal asphyxial encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve cerebral metabolism and structure.
The study hypothesis is that: Following perinatal asphyxia treatment with a combination of hypothermia and inhaled xenon preserves cerebral metabolism and structure. Following informed parental consent, infants that continue to require endotracheal tube ventilation following resuscitation will be randomised to treatment with hypothermia only or hypothermia and xenon. All infants in both groups will be treated with hypothermia for 72 hours started within 6 hours of delivery and infants allocated to hypothermia and xenon will also receive 30% xenon (balanced with oxygen and air) for 24 hours through a purpose designed delivery system. Structured neurological examination will be done daily during the 1st week after birth and at discharge. MRS and MRI will be performed once between 4-10 days of age. MRS/MRI data analysis will be by investigators blinded to the allocated intervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Infants will be eligible for enrolment into the trial if each of the following criteria is fulfilled:
Infants 36 to 43 weeks gestation with at least one of the following:
Exclusion Criteria:
Combination of hypothermia and inhaled xenon
Other: Xenon gas
Hypothermia and standard intensive care
30% Xenon gas inhaled for 24 hours
Also known as: LENOXe
Lactate (Lac) / N Acetyl Aspartate (NAA) Ratio on Magnetic Resonance Spectroscopy
Cerebral Lac/NAA ratio measured by magnetic resonance spectroscopy in patents
Time frame: 10 days
Cerebral Fractional Anisotropy Measured by Diffusion Weighted Magnetic Resonance Imaging
Fractional anisotropy (FA) is a measure of tissue integrity in white matter tracts measured by diffusion tensor MRI, and it has been used in work in animals to assess potential neuroprotectants and can be used to predict subsequent neurological outcomes after birth asphyxia, including in infants treated with moderate hypothermia. It is a scalar value between 0-1 that describe anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions" or similar. Fractional anisotropy data were extracted froma mask of the posterior limb of the internal capsule via tract-based spatial statistics. \*Coefficient of variation=√(exp(var)-1), where var is the variance on the log scale
Time frame: 10 days
Amiel Tison Evaluation at Hospital Discharge
Amiel Tison neurological assessment at discharge from hospital. Amiel Tison evaluation was developed to detect transient and permanent abnormalities in an infant's neuromotor development. Its main focus is to examine active and passive muscle tone.
Time frame: At discharge from hospital
| Milestone | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care |
|---|---|---|
| Started | 46 | 46 |
| Completed | 33 | 34 |
| Not completed | 13 | 12 |
| Withdrew: Missing scan | 5 | 9 |
| Withdrew: Death | 8 | 3 |
Cerebral Lac/NAA ratio measured by magnetic resonance spectroscopy in patents
| ratio | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care |
|---|---|---|
| Lactate (Lac) / N Acetyl Aspartate (NAA) Ratio on Magnetic Resonance Spectroscopy | 0.25 ± 1.30 | 0.28 ± 1.45 |
Fractional anisotropy (FA) is a measure of tissue integrity in white matter tracts measured by diffusion tensor MRI, and it has been used in work in animals to assess potential neuroprotectants and can be used to predict subsequent neurological outcomes after birth asphyxia, including in infants treated with moderate hypothermia. It is a scalar value between 0-1 that describe anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions" or similar. Fractional anisotropy data were extracted froma mask of the posterior limb of the internal capsule via tract-based spatial statistics. \*Coefficient of variation=√(exp(var)-1), where var is the variance on the log scale
| units on a scale | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care |
|---|---|---|
| Cerebral Fractional Anisotropy Measured by Diffusion Weighted Magnetic Resonance Imaging | 0.40 ± 0.05 | 0.40 ± 0.05 |
Amiel Tison neurological assessment at discharge from hospital. Amiel Tison evaluation was developed to detect transient and permanent abnormalities in an infant's neuromotor development. Its main focus is to examine active and passive muscle tone.
| Participants | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care |
|---|---|---|
| Normal or mildly abnormal | 30 | 29 |
| Moderately abnormal | 3 | 7 |
| Very abnormal | 2 | 1 |
Collected over 10days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combination of Hypothermia and Xenon | 11/46 (23.9%) | 0/46 (0%) | 2/46 (4.3%) |
| Hypothermia and Standard Intensive Care | 9/46 (19.6%) | 0/46 (0%) | 0/46 (0%) |
| Event | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care |
|---|---|---|
| Subcutaneous fat necrosisSkin and subcutaneous tissue disorders | 1/46 | 0/46 |
| Transient desaturation during MRI scanGeneral disorders | 1/46 | 0/46 |
| Age, Continuous(weeks, gestation) | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care | Total |
|---|---|---|---|
| Mean | 39.8 ± 1.7 | 39.8 ± 1.3 | 39.8 ± 1.5 |
| Sex: Female, Male(Participants) | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care | Total |
|---|---|---|---|
| Female | 20 | 25 | 45 |
| Male | 26 | 21 | 47 |
| Race and Ethnicity Not Collected(Participants) | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Combination of Hypothermia and Xenon | Hypothermia and Standard Intensive Care | Total |
|---|---|---|---|
| United Kingdom | 46 | 46 | 92 |
Plan to share: No
The record gives a start of Feb 2012, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2022, 7 years 7 months after primary completion.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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