Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
Recruiting
Phase 4
Interventional Study
Hypotension and Shock
Pulmonary Hypertension of the Newborn (PPHN)
Hypoxemic Respiratory Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 28 Days
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- University of California, Davis · Other
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About This Trial
This pilot randomized clinical trial compares dopamine and norepinephrine as first-line vasoactive therapies in term and late preterm neonates with pulmonary hypertension associated with hypoxemic respiratory failure and systemic hypotension. Systemic hypotension is a common and clinically significant complication of persistent pulmonary hypertension of the newborn (PPHN) and frequently requires v…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Postmenstrual age \> 34 6/7 weeks and Postnatal age ≤ 28 days
2. On respiratory support (Invasive mechanical ventilation, NIPPV, CPAP, HFNC ≥ 2 LPM) and FiO2 ≥ 0.3
3. Echocardiographic evidence of pulmonary hypertension
4. Mean arterial pressure below the threshold for gestat…
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