N/A
Completed N=92
Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Hypoxic Ischaemic Encephalopathy
Source: ClinicalTrials.gov NCT00934700 ↗
Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Lactate (Lac) / N Acetyl Aspartate (NAA) Ratio on Magnetic Resonance Spectroscopy — 0.25; 0.28 ratio
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lactate (Lac) / N Acetyl Aspartate (NAA) Ratio on Magnetic Resonance Spectroscopy |
0.25; 0.28 | — |
| PRIMARY Cerebral Fractional Anisotropy Measured by Diffusion Weighted Magnetic Resonance Imaging |
0.40; 0.40 | — |
| SECONDARY Amiel Tison Evaluation at Hospital Discharge |
30; 29; 3; 7; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
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:
- Apgar score of 15 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood).
- Moderate to severe encephalopathy consisting of altered state of consciousness (reduced or absent response to stimulation) and hypotonia, and abnormal primitive reflexes (weak or absent suck or Moro response). Clinical severity of HIE will be assessed by Thompson encephalopathy score, and modified Sarnat score.
- At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows moderately abnormal or suppressed background aEEG activity or seizures
Exclusion Criteria
- If treatment with hypothermia is delayed beyond 6 hours, or infants are expected to be >12 hours of age at the time of randomisation; Infants with ventilatory oxygen requirement > 70%; Attending clinician considers infant not suitable to participate because of other serious congenital abnormalities, or the infant's condition appears terminal.
Data sourced from ClinicalTrials.gov (NCT00934700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.