NCT07322133RecruitingPhase 4
Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
Dopamine vs. Norepinephrine in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure and Systemic Hypotension Due to Pulmonary Hypertension: A Pilot Trial
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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 vasopressor support to maintain adequate systemic perfusion. Dopamine is commonly used in this setting; however, prior animal experimental and clinical data suggest it may increase pulmonary vascular resistance, potentially worsening right ventricular afterload and hypoxemia. Norepinephrine may preferentially increase systemic vascular resistance with less effect on the pulmonary circulation. This study evaluates short-term hemodynamic and oxygenation responses following initiation of dopamine or norepinephrine.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of California, Davis
- NCT number
- NCT07322133
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 30 Oct 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe hypoxic respiratory failure (OI \> 35 or SpO2 \< 75% on 100% FiO2 for \> 60 minutes)
- Complex congenital heart disease beyond specified criteria
Age
- Gestational age \< 32 weeks
Other
- Lethal anomalies (e.g., trisomy 13 or 18)
Who the study is looking for
- Postmenstrual age \> 34 6/7 weeks and Postnatal age ≤ 28 days
- On respiratory support (Invasive mechanical ventilation, NIPPV, CPAP, HFNC ≥ 2 LPM) and FiO2 ≥ 0.3
- Echocardiographic evidence of pulmonary hypertension
- Mean arterial pressure below the threshold for gestational age despite a 10-20 mL/kg fluid bolus
- Permissible Comorbidities: CDH, trisomy 21, HIE on hypothermia, PDA, PFO/ASD, VSD \< 2 mm
Age in the registry: - to 28 days · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UC Davis Children's Hospital Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.