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
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.
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
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Imperial College London