Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
NCT ID: NCT05836610
Last Updated: 2023-05-03
Study Results
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Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2021-09-21
2027-09-30
Brief Summary
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The hypothesis is that a detailed study of hydrocortisone pharmacokinetics during therapeutic hypothermia would help to personalize steroid supplementation in asphyxiated neonates. As the overall metabolic rate decreases with lower body temperature, drug metabolism is likely to be reduced as well, and lower doses, or less frequent dosing will be sufficient to achieve the targeted steroid range and biological effects in asphyxiated neonates with relative adrenal insufficiency. Thus, the investigators are planning to measure initial, baseline serum cortisol levels and serial serum cortisol levels after hydrocortisone supplementation in cooled asphyxiated neonates.
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Detailed Description
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Asphyxiated infants often present with multiorgan failure and low blood pressure. Therapeutic hypothermia, the standard of care, could worsen hemodynamic instability; therefore, treatment of cardiovascular impairment represents a major challenge in this clinical setting. An association was previously described between hypotension and low serum cortisol values in this patient population, and it was suggested that relative adrenal insufficiency (RAI) is an important factor in the circulatory compromise of these patients. In the "CORTISoL" clinical trial, it was also demonstrated that low-dose hydrocortisone therapy was effective in the treatment of cardiovascular impairment in asphyxiated neonates; however, some gaps remain in the knowledge on optimal dosing. Importantly, steroid therapy should be administered at the lowest effective dose and for the shortest possible duration in this vulnerable population.
In the current pharmacokinetic study, the investigators propose a stepwise approach to more detailed understanding of RAI and hydrocortisone pharmacokinetics in asphyxiated neonates. The findings would certainly aid clinical decision-making and allow for more personalized therapeutic interventions for the treatment of hemodynamic instability.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Standard dose hydrocortisone
The standard dose of hydrocortisone therapy in neonates for hypotension is 0.5 mg/kg every 6 hours.
Hydrocortisone
intravenous bolus hydrocortisone therapy during hypothermia treatment
Modified dose hydrocortisone
The modified dose of hydrocortisone therapy will be determined based on the pharmacokinetic results.
Hydrocortisone
intravenous bolus hydrocortisone therapy during hypothermia treatment
Interventions
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Hydrocortisone
intravenous bolus hydrocortisone therapy during hypothermia treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* provision of whole-body hypothermia treatment (as described by Azzopardi et al.)
* presence of systemic hypotension (defined as a mean arterial pressure less than the gestational age in weeks)
* indication for hydrocortisone treatment during hypothermia by the attending physician
* indwelling arterial catheter to take blood samples without additional painful punctures: umbilical arterial catheter or peripheral arterial catheter
* written informed parental consent
Exclusion Criteria
* critical congenital abnormalities
* genetic disease
* signed informed consent is unavailable
72 Hours
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Kata Kovacs
Assistant lecturer
Principal Investigators
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Kata Kovacs, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University
Miklós Szabó, MD, PhD
Role: STUDY_DIRECTOR
Semmelweis University
Locations
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Semmelweis University Department of Pediatrics (Bókay street Unit)
Budapest, Pest County, Hungary
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Kovacs 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.
Kovacs K, Szakmar E, Meder U, Cseko A, Szabo AJ, Szabo M, Jermendy A. Serum cortisol levels in asphyxiated infants with hypotension. Early Hum Dev. 2018 May;120:40-45. doi: 10.1016/j.earlhumdev.2018.03.003. Epub 2018 Apr 4. No abstract available.
Watterberg KL. Hydrocortisone Dosing for Hypotension in Newborn Infants: Less Is More. J Pediatr. 2016 Jul;174:23-26.e1. doi: 10.1016/j.jpeds.2016.04.005. Epub 2016 May 4. No abstract available.
Concepcion KR, Zhang L. Corticosteroids and perinatal hypoxic-ischemic brain injury. Drug Discov Today. 2018 Oct;23(10):1718-1732. doi: 10.1016/j.drudis.2018.05.019. Epub 2018 May 17.
Sarkar S, Barks JD. Systemic complications and hypothermia. Semin Fetal Neonatal Med. 2010 Oct;15(5):270-5. doi: 10.1016/j.siny.2010.02.001. Epub 2010 Mar 12.
Other Identifiers
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SU-Ped-AsphCort 002
Identifier Type: -
Identifier Source: org_study_id
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