Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia. MedDRA version: 12 Level: LLT Classification code 10028923 Term: Neonatal asphyxia MedDRA version: 12 Level: PT Classification code 10028923 Term: Neonatal asphyxia MedDRA version:
Conditions
Interventions
Product Name: Xenon
Product Code: from BOC
Pharmaceutical Form: Inhalation gas
Sponsors
University Hospital Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants will be eligible for xenon if the St Michael’s standard inclusion criteria for cooling are met Standard Hypothermia Treatment Criteria for 72 hrs of cooling — all of criteria A, B, and C. A Infants > 36.0 weeks gestation (clinical assessment) with at least ONE of the following: 1 Apgar score of 10µV and lower margin 2.3 kg. 4) No evidence of infection. 5) Stable cardiovascular parameters; Mean arterial pressure >45mmHg. 6) Oxygen requirement via mechanical ventilator =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for cooling 1. Infants expected to be greater than 12 hours of age at the time of starting cooling treatment. 2. Futility. Where prognosis is considered to be hopeless e.g. no cardiac output for 20 minutes. Failure to meet the additional inclusion criteria for xenon: Before being considered for additional inhaled xenon therapy via the breathing gas mixture, the infant would need to meet further additional entry criteria: 1) Intubated, ventilated, sedated, being cooled. 2) Any seizures under control. 3) Weight > 2.3 kg. 4) No evidence of infection. 5) Stable cardiovascular parameters; Mean arterial pressure >45mmHg. 6) Oxygen requirement via mechanical ventilator < 35%. 7) Positive End Expiratory Pressure (PEEP) requirement < 6mmHg 8) Arterial pCO2 within the accepted range (4.5-6.5 kPa) 9) Postnatal age <18 hours 10) Major congenital abnormalities, imperforate anus and congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is designed to explore the technical feasibility of delivering the inhaled gas xenon in neonatal intensive care and to detect the unlikely event of derangement of body function not previously detected in its use with adults during anaesthesia and in the newborn of two animal species.; Primary end point(s): This is a feasibility study of adding xenon inhalation to the the established treatment of cooling the body down to 33.5 C for days. 1)Our hypothesis is that we will observe no changes in those clinical and biochemical markers that we routinely monitor in infants who receive cooling therapy. We have local comparable data (infants recruited with same entry criteria) from 50 cooled infants (in the anomyised database described in REC09/Ho106/3). 2)We will monitor a number of variables: Gas exchange: Oxygen saturation, end-tidal carbon dioxide concentration, blood gas data, mechanical ventilation requirements (rate, peak inspiratory pressure, PEEP settings). Alveolar-arterial oxygen gradient [P(A - a)O2]. Haemodynamic: Mean arterial pressure, heart rate. Any problems during weaning and extubation, such as post-extubation stridor. In addition we have looked at other variables in our own cooled babies which we also intend to record in this study: 1] Inotrope requirement, TroponinI 2] Hepatic impairment, [raised Alanine aminotransferase > 40, Alkaline phospatase > 100] 3] Renal impairment, oliguria [urine output 100] 4] Infection [culture proven, need for antibiotics ~ 5 days, raised CRP ~ within 4 days of life] 5] Length of hospital stay 6] Coagulopathy [INR >2, APTT> 50] 7] Seizures (from EEG recording) The study is designed to explore the technical feasibility of delivering the inhaled gas xenon in ne | — |
Countries
United Kingdom
Outcome results
None listed