A Phase 2/3 interventional study of Hydrocortisone and Placebo in Hypoxic-Ischemic Encephalopathy and Asphyxia, sponsored by Semmelweis University. Completed at 1 site in Hungary. Open to participants aged Up to 72 Hours. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Semmelweis University · Phase 2/3, Interventional, and Treatment
This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed.
The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency that may contribute to hypotension and lower efficacy of inotropic therapy in this patient population. Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation besides conventional inotropic therapy in a placebo-controlled fashion.
Hypothesis:
The researchers hypothesized that asphyxiated neonates undergoing therapeutic hypothermia develop relative adrenal insufficiency that contributes to "late onset" (>24 hours after birth) hypotension resistant to optimized pharmacological support.
Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation.
Specific aims:
Methodology:
Drugs for hypotension, the hydrocortisone protocol:
Randomization, irrespective of actual cortisol level. As the study is blinded, enrollment in the clinical trial will/shall not influence the clinical decision making about further interventions. A dedicated study assistant will be available to prepare the drug / placebo for the newborns.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's enrollment of 32 is below the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
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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.
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:
B. Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following:
C. At least 30 minutes duration of aEEG recording that shows abnormal background aEEG activity or seizures. There must be one of the following:
During hypothermia treatment low blood pressure was detected and treated with the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hydrocortisone is the pharmaceutical term for cortisol, the principal glucocorticoid secreted by the adrenal gland
Drug: Hydrocortisone
Isotonic sodium chloride is an aqueous solution of 0.9 percent sodium chloride which is isotonic with the blood and tissue fluid
Drug: Placebo
4 \* 0,5 mg/kg /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
Also known as: Solu-Cortef
4 \* 2 ml isotonic sodium chloride solution /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
Also known as: Isotonic saline
Compare mean arterial blood pressure (MAP) change in the patients receiving hydrocortisone vs placebo
Circulatory stability as measured by an increased MAP (5 mmHg) within two hours after drug administration
Time frame: 2 hours
Frequency of initially low serum cortisol in hypotensive asphyxiated newborns undergoing therapeutic hypothermia
Initially low serum cortisol - proven relative adrenal insufficiency
Time frame: before hydrocortisone administration within max. 72 hours
Length of dopamine treatment in the patients receiving hydrocortisone vs placebo
Compare dopamine treatment's length (in hours) in the patients receiving hydrocortisone vs placebo
Time frame: 72 hours
Cumulative dopamine dose in the patients receiving hydrocortisone vs placebo
Compare cumulative dopamine dose (mcg/kg) in the patients receiving hydrocortisone vs placebo
Time frame: 72 hours
Change in hourly diuresis in the patients receiving hydrocortisone vs placebo
Measure and compare the hourly diuresis (ml/kg/hour) in the patients receiving hydrocortisone vs placebo
Time frame: 72 hours
Change in the echocardiography parameters (fractional shortening and cardiac output) in the patients receiving hydrocortisone vs placebo
Fractional shortening (FS%) and cardiac output (CO in ml/kg/min) measurements before and after hydrocortisone or placebo, during the first 72 hours (during hypothermia treatment)
Time frame: 72 hours
Long term neurodevelopmental outcome in the patients receiving hydrocortisone vs placebo
Performance on motor and mental scales of Bayley II/III scales of infant development
Time frame: 18-22 month
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone