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New treatment option for Hypoxic-Ischemic Encephalopathy
Official title Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
ClinicalTrials.gov ID: NCT05836610
What this study is testing
What is Hydrocortisone?
Hydrocortisone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hypoxic-ischemic encephalopathy.
Also referred to as Solu-Cortef.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to hydrocortisone supplementation while receiving conventional inotropic therapy as needed.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 72
You may be able to join if
- gestational age ≥ 36 weeks
- 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
You likely can't join if
- infants who are expected to be \> 6 hours of age (not suitable for cooling)
- critical congenital abnormalities
- genetic disease
- signed informed consent is unavailable
See the full eligibility criteria
- gestational age ≥ 36 weeks
- 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
- infants who are expected to be \> 6 hours of age (not suitable for cooling)
- critical congenital abnormalities
- genetic disease
- signed informed consent is unavailable
The study team makes the final eligibility decision.
Where it's taking place
- Budapest, Pest County, Hungary
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 72 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Budapest, Pest County, Hungary. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.