Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation

What Was Tested

In this phase 1 trial, researchers set out to test Vasopressin.

When a baby is born with a low heart rate or no heart rate, the clinical team must provide breathing support and chest compressions (what is call cardiopulmonary resuscitation or CPR).

During CPR, the most common medication given is called epinephrine.

It had two arms (groups): Epinephrine (active comparator) and Vasopressin (experimental).

The registry classes the interventions as drug.

More on the Plan

Guidelines for neonatal resuscitation recognized the lack of neonatal data and extrapolate data from studies with adults and adult/pediatric animal studies.

Those data may not apply wholly to the neonatal population.

Therefore, neonatal data are needed to determine the optimal vasopressor therapy during neonatal resuscitation.

Justification Most newborn infants successfully make the transition from fetal to neonatal life without help.

Who Took Part

8 planned participants were the target.

It was open to people of any sex aged from 0 Minutes up to 20 Minutes.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

Each person switched between Vasopressin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Vasopressin.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2023-11-27 with completion listed for 2026-01-13.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to ROSC (Return of spontaneous Circulation) (time frame: up to 60 Minutes of chest compression).

It also tracked 13 secondary outcomes, for example Mortality, Number of Patients who have brain injury, Admission temperature, Use of therapeutic cooling, Mode of mechanical ventilation and Cerebral regional oxygen saturation.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Vasopressin in 8 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.