Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns (CORTISoL)
Hypoxic-Ischemic Encephalopathy, Asphyxia
About this trial
This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring Hypothermia treatment, Circulatory failure, Neonatal hypotension, Relative adrenal insufficiency, Hydrocortisone supplementation
Eligibility Criteria
Inclusion Criteria:
The infant will be assessed sequentially by criteria A, B and C, as described by the TOBY trial and listed below, to be eligible for hypothermia treatment.
A. Infants ≥ 36 completed weeks of gestation admitted to the NICU with at least one of the following:
- Apgar score of ≤ 5 at 10 minutes after birth
- Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
- Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord, arterial or capillary pH < 7.00)
- Base Deficit ≥ 16 mmol/L in umbilical cord or any blood sample (arterial, venous or capillary) within 60 minutes of birth
B. Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following:
- hypotonia
- abnormal reflexes including oculomotor or pupillary abnormalities
- absent or weak suck
- clinical seizures
C. At least 30 minutes duration of aEEG recording that shows abnormal background aEEG activity or seizures. There must be one of the following:
- normal background with some seizure activity
- moderately abnormal activity
- suppressed activity
- continuous seizure activity
- Invasive arterial blood pressure measurement: umbilical arterial catheter or peripheral arterial catheter to measure invasively the arterial blood pressure.
During hypothermia treatment low blood pressure was detected and treated with the following:
- fluid therapy: 10-20 ml/kg isotonic NaCl if hypotension is still present
- inotropic therapy: dopamine in parallel with study intervention
- A written informed consent has been obtained from a parent of each infant after explanation of the study.
Exclusion Criteria:
- Signed informed consent is unavailable.
- Infants who are expected to be > 6 hours of age (not suitable for cooling).
- Congenital abnormalities, cardiac anomalies, meconium aspiration syndrome.
- Low blood pressure coincides with high heart rate (>120/min) in cooled infants, suggesting hypovolaemia.
- Haematocrit level < 35%.
- Need for combined, ≥2 types of inotropic therapy.
Sites / Locations
- Semmelweis University, 1st Department of Paediatrics
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Hydrocortisone
Placebo
Hydrocortisone is the pharmaceutical term for cortisol, the principal glucocorticoid secreted by the adrenal gland
Isotonic sodium chloride is an aqueous solution of 0.9 percent sodium chloride which is isotonic with the blood and tissue fluid