Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 72
SponsorSemmelweis University

About this trial

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.

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

infants who are expected to be > 6 hours of age (not suitable for cooling)

critical congenital abnormalities

genetic disease

signed informed consent is unavailable

Trial design

Treatments tested in this trial

  • Hydrocortisone

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Semmelweis University Department of Pediatrics (Bókay street Unit)Recruiting1083, Budapest, Pest CountyHungaryHungary

Sponsors and collaborators