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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Hydrocortisone

    Drug

    intravenous bolus hydrocortisone therapy during hypothermia treatment

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard dose hydrocortisoneActive comparator 1 intervention
Group B: Modified dose hydrocortisoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean blood pressure increase

5 mmHg increase in mean arterial blood pressure after drug administration

Time frame
2 hours

Secondary outcomes

1

Cardiovascular management

Length, cumulative and peak dose of inotrope treatment

Time frame
72 hours
2

Presence of relative adrenal insufficiency at baseline

Low serum cortisol level at baseline

Time frame
Before hydrocortisone administration within max. 72 hours
3

MRI outcome

Brain injury on MRI examinations

Time frame
4-10 days
4

Long term neurodevelopmental outcome

Performance on motor and mental scales of Bayley III scales of infant development

Time frame
18-42 month

Other outcomes

1

Multiorgan failure

Presence of multiorgan failure during hypothermia

Time frame
72 hours

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 contacts

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