Hypoxic-Ischemic EncephalopathyPhase 2/3CORTISoLNCT02700828
Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns
A Phase 2/3 study testing Hydrocortisone in people with Hypoxic-Ischemic Encephalopathy and Asphyxia, run by Semmelweis University at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Asphyxia
- What is being tested?
- Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteHungary
- Study dates
- Feb 2016to 15 Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- 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
Show all 21Show fewer
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, 1st Department of Paediatrics
Budapest, Pest County, 1083
About this study
Official title: Prospective, Randomized, Double-blind, Cohort Study of Hydrocortisone vs Placebo in Systemic Low Blood Pressure During Hypothermia Treatment in Asphyxiated Newborns
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.
Read the detailed description
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:
- To study initial serum cortisol levels in asphyxiated newborns undergoing therapeutic hypothermia with late onset hypotension.
- To demonstrate that in asphyxiated newborns undergoing therapeutic hypothermia and presenting with systemic hypotension resistant to optimized pharmacological support, low dose hydrocortisone supplementation restores normal blood pressure when compared to placebo.
Methodology:
- Prospective, randomized, double-blind, single center, cohort study
- 1st Department of Paediatrics, NICU, Semmelweis University, Hungary
- Starting date: 02/14/2016
- Patient number: 16 vs 16 (hydrocortisone vs placebo - based on previous observational study results)
- Intervention (hydrocortisone vs placebo) applied only during therapeutic hypothermia (max. 72 hours)
- Neurodevelopmental follow-up visit: Bayley II/III scale to evaluate the effect of hydrocortisone treatment on the neurological development at the age between 18 and 22 months.
Drugs for hypotension, the hydrocortisone protocol:
- Fluid replacement (volume bolus: 10-20 ml/kg isotonic saline, over 15 minutes, according to the clinician's decision)
- In case of persisting hypotension: serum sample is collected for cortisol measurement.
- 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.
- Inotropic therapy (dopamine, following the standard titration protocol)
- AND (at start of dopamine) hydrocortisone: 4 * 0,5 mg/kg /24 hours (in every 6 hours) or placebo administration (the corresponding amount of isotonic saline)
- After randomization, intervention is continued until the end of hypothermia treatment (max. 72 hours), with the same dose. Inotropic therapy will be titrated as needed.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Asphyxia
- Being tested
- Hydrocortisone, Placebo
- Keywords
- Hypothermia treatment, Circulatory failure, Neonatal hypotension, Relative adrenal insufficiency, Hydrocortisone supplementation
- Medical subject headings
- Hypoxia-Ischemia, Brain, Asphyxia, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Solu-Cortef
4 * 0,5 mg/kg /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
PlaceboDrug
Also called Isotonic saline
4 * 2 ml isotonic sodium chloride solution /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Active comparator | Hydrocortisone is the pharmaceutical term for cortisol, the principal glucocorticoid secreted by the adrenal gland Receives: Drug: Hydrocortisone |
| Placebo | Placebo comparator | Isotonic sodium chloride is an aqueous solution of 0.9 percent sodium chloride which is isotonic with the blood and tissue fluid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (6)
Frequency of initially low serum cortisol in hypotensive asphyxiated newborns undergoing therapeutic hypothermia
Initially low serum cortisol - proven relative adrenal insufficiency
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 18-22 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2017
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Jermendy MD PhD MPH, Semmelweis University
- Investigators
- Miklós Szabó, MD, PhD, Study director, Semmelweis University, 1st Department of Paediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700828
- Sponsor's protocol ID
- 1Ped-AsphCort 001
- Acronym
- CORTISoL
- Status last verified
- Apr 2023
- First submitted
- 24 Feb 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854.
PubMed 19797281Noori S, Friedlich P, Wong P, Ebrahimi M, Siassi B, Seri I. Hemodynamic changes after low-dosage hydrocortisone administration in vasopressor-treated preterm and term neonates. Pediatrics. 2006 Oct;118(4):1456-66. doi: 10.1542/peds.2006-0661.
PubMed 17015536Ibrahim H, Sinha IP, Subhedar NV. Corticosteroids for treating hypotension in preterm infants. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD003662. doi: 10.1002/14651858.CD003662.pub4.
PubMed 22161379Rios DR, Moffett BS, Kaiser JR. Trends in pharmacotherapy for neonatal hypotension. J Pediatr. 2014 Oct;165(4):697-701.e1. doi: 10.1016/j.jpeds.2014.06.009. Epub 2014 Jul 16.
PubMed 25039051Hebbar KB, Stockwell JA, Leong T, Fortenberry JD. Incidence of adrenal insufficiency and impact of corticosteroid supplementation in critically ill children with systemic inflammatory syndrome and vasopressor-dependent shock. Crit Care Med. 2011 May;39(5):1145-50. doi: 10.1097/CCM.0b013e31820eb4e4.
PubMed 21336126Ng PC, Lam CW, Fok TF, Lee CH, Ma KC, Chan IH, Wong E. Refractory hypotension in preterm infants with adrenocortical insufficiency. Arch Dis Child Fetal Neonatal Ed. 2001 Mar;84(2):F122-4. doi: 10.1136/fn.84.2.f122.
PubMed 11207229Ng PC, Lee CH, Bnur FL, Chan IH, Lee AW, Wong E, Chan HB, Lam CW, Lee BS, Fok TF. A double-blind, randomized, controlled study of a "stress dose" of hydrocortisone for rescue treatment of refractory hypotension in preterm infants. Pediatrics. 2006 Feb;117(2):367-75. doi: 10.1542/peds.2005-0869.
PubMed 16452355Seri I, Tan R, Evans J. Cardiovascular effects of hydrocortisone in preterm infants with pressor-resistant hypotension. Pediatrics. 2001 May;107(5):1070-4. doi: 10.1542/peds.107.5.1070.
PubMed 11331688Kovacs K, Szakmar E, Meder U, Szakacs L, Cseko A, Vatai B, Szabo AJ, McNamara PJ, Szabo M, Jermendy A. A Randomized Controlled Study of Low-Dose Hydrocortisone Versus Placebo in Dopamine-Treated Hypotensive Neonates Undergoing Hypothermia Treatment for Hypoxic-Ischemic Encephalopathy. J Pediatr. 2019 Aug;211:13-19.e3. doi: 10.1016/j.jpeds.2019.04.008. Epub 2019 May 30.
PubMed 31155392Kovacs K, Szakmar E, Dobi M, Varga Z, Meder U, Szabo AJ, McNamara PJ, Szabo M, Jermendy A. Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial. J Perinatol. 2025 Dec;45(12):1788-1794. doi: 10.1038/s41372-025-02428-5. Epub 2025 Sep 22.
PubMed 40983658
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind, Cohort Study of Hydrocortisone vs Placebo in Systemic Low Blood Pressure During Hypothermia Treatment in Asphyxiated Newborns
- ClinicalTrials.gov ID
- NCT02700828
- Acronym / sponsor ID
- CORTISoL / 1Ped-AsphCort 001
- Conditions
- Hypoxic-Ischemic Encephalopathy, Asphyxia
- Keywords
- Hypothermia treatment, Circulatory failure, Neonatal hypotension, Relative adrenal insufficiency, Hydrocortisone supplementation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To study initial serum cortisol levels in asphyxiated newborns undergoing therapeutic hypothermia with late onset hypotension.
- To demonstrate that in asphyxiated newborns undergoing therapeutic hypothermia and presenting with systemic hypotension resistant to optimized pharmacological support, low dose hydrocortisone supplementation restores normal blood pressure when compared to placebo.
Methodology:
- Prospective, randomized, double-blind, single center, cohort study
- 1st Department of Paediatrics, NICU, Semmelweis University, Hungary
- Starting date: 02/14/2016
- Patient number: 16 vs 16 (hydrocortisone vs placebo - based on previous observational study results)
- Intervention (hydrocortisone vs placebo) applied only during therapeutic hypothermia (max. 72 hours)
- Neurodevelopmental follow-up visit: Bayley II/III scale to evaluate the effect of hydrocortisone treatment on the neurological development at the age between 18 and 22 months.
Drugs for hypotension, the hydrocortisone protocol:
- Fluid replacement (volume bolus: 10-20 ml/kg isotonic saline, over 15 minutes, according to the clinician's decision)
- In case of persisting hypotension: serum sample is collected for cortisol measurement.
- 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.
- Inotropic therapy (dopamine, following the standard titration protocol)
- AND (at start of dopamine) hydrocortisone: 4 * 0,5 mg/kg /24 hours (in every 6 hours) or placebo administration (the corresponding amount of isotonic saline)
- After randomization, intervention is continued until the end of hypothermia treatment (max. 72 hours), with the same dose. Inotropic therapy will be titrated as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Active comparator | Drug: HydrocortisoneHydrocortisone is the pharmaceutical term for cortisol, the principal glucocorticoid secreted by the adrenal gland |
| Placebo | Placebo comparator | Drug: PlaceboIsotonic sodium chloride is an aqueous solution of 0.9 percent sodium chloride which is isotonic with the blood and tissue fluid |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- 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.
- 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:
- A written informed consent has been obtained from a parent of each infant after explanation of the study.
Key exclusion criteria (6 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: Solu-Cortef4 * 0,5 mg/kg /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours) | Drug | Hydrocortisone |
| PlaceboAlso: Isotonic saline4 * 2 ml isotonic sodium chloride solution /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours) | Drug | Placebo |
Primary outcome
Compare mean arterial blood pressure (MAP) change in the patients receiving hydrocortisone vs placebo
Time frame: 2 hours
Circulatory stability as measured by an increased MAP (5 mmHg) within two hours after drug administration
6 secondary outcomes
Frequency of initially low serum cortisol in hypotensive asphyxiated newborns undergoing therapeutic hypothermia
Time frame: before hydrocortisone administration within max. 72 hours
Length of dopamine treatment in the patients receiving hydrocortisone vs placebo
Time frame: 72 hours
Cumulative dopamine dose in the patients receiving hydrocortisone vs placebo
Time frame: 72 hours
Change in hourly diuresis 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
Time frame: 72 hours
Long term neurodevelopmental outcome in the patients receiving hydrocortisone vs placebo
Time frame: 18-22 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Background: PubMed 19797281Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854.
- Background: PubMed 17015536Noori S, Friedlich P, Wong P, Ebrahimi M, Siassi B, Seri I. Hemodynamic changes after low-dosage hydrocortisone administration in vasopressor-treated preterm and term neonates. Pediatrics. 2006 Oct;118(4):1456-66. doi: 10.1542/peds.2006-0661.
- Background: PubMed 22161379Ibrahim H, Sinha IP, Subhedar NV. Corticosteroids for treating hypotension in preterm infants. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD003662. doi: 10.1002/14651858.CD003662.pub4.
- Background: PubMed 25039051Rios DR, Moffett BS, Kaiser JR. Trends in pharmacotherapy for neonatal hypotension. J Pediatr. 2014 Oct;165(4):697-701.e1. doi: 10.1016/j.jpeds.2014.06.009. Epub 2014 Jul 16.
- Background: PubMed 21336126Hebbar KB, Stockwell JA, Leong T, Fortenberry JD. Incidence of adrenal insufficiency and impact of corticosteroid supplementation in critically ill children with systemic inflammatory syndrome and vasopressor-dependent shock. Crit Care Med. 2011 May;39(5):1145-50. doi: 10.1097/CCM.0b013e31820eb4e4.
- Background: PubMed 11207229Ng PC, Lam CW, Fok TF, Lee CH, Ma KC, Chan IH, Wong E. Refractory hypotension in preterm infants with adrenocortical insufficiency. Arch Dis Child Fetal Neonatal Ed. 2001 Mar;84(2):F122-4. doi: 10.1136/fn.84.2.f122.
- Background: PubMed 16452355Ng PC, Lee CH, Bnur FL, Chan IH, Lee AW, Wong E, Chan HB, Lam CW, Lee BS, Fok TF. A double-blind, randomized, controlled study of a "stress dose" of hydrocortisone for rescue treatment of refractory hypotension in preterm infants. Pediatrics. 2006 Feb;117(2):367-75. doi: 10.1542/peds.2005-0869.
- Background: PubMed 11331688Seri I, Tan R, Evans J. Cardiovascular effects of hydrocortisone in preterm infants with pressor-resistant hypotension. Pediatrics. 2001 May;107(5):1070-4. doi: 10.1542/peds.107.5.1070.
- Results publication: PubMed 31155392Kovacs K, Szakmar E, Meder U, Szakacs L, Cseko A, Vatai B, Szabo AJ, McNamara PJ, Szabo M, Jermendy A. A Randomized Controlled Study of Low-Dose Hydrocortisone Versus Placebo in Dopamine-Treated Hypotensive Neonates Undergoing Hypothermia Treatment for Hypoxic-Ischemic Encephalopathy. J Pediatr. 2019 Aug;211:13-19.e3. doi: 10.1016/j.jpeds.2019.04.008. Epub 2019 May 30.
- Derived from this study: PubMed 40983658Kovacs K, Szakmar E, Dobi M, Varga Z, Meder U, Szabo AJ, McNamara PJ, Szabo M, Jermendy A. Neurodevelopmental outcome in infants with neonatal encephalopathy receiving hydrocortisone during therapeutic hypothermia: follow-up of the extended-CORTISoL trial. J Perinatol. 2025 Dec;45(12):1788-1794. doi: 10.1038/s41372-025-02428-5. Epub 2025 Sep 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miklós Szabó, MD, PhD study director
Semmelweis University, 1st Department of Paediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydrocortisone in people with Hypoxic-Ischemic Encephalopathy and Asphyxia, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare mean arterial blood pressure (MAP) change in the patients receiving hydrocortisone vs placebo (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700828, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.