NCT07322133 Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
| NCT ID | NCT07322133 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Davis |
| Condition | Hypotension and Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-30 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-06-30 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 gestational age despite a 10-20 mL/kg fluid bolus Permissible Comorbidities: CDH, trisomy 21, HIE on hypothermia, PDA, PFO/ASD, VSD \< 2 mm Exclusion Criteria: 1. Gestational age \< 32 weeks 2. Severe hypoxic respiratory failure (OI \> 35 or SpO2 \< 75% on 100% FiO2 for \> 60 minutes) 3. Lethal anomalies (e.g., trisomy 13 or 18) 4. Complex congenital heart disease beyond specified criteria
Contact & Investigator
Deepika Sankaran, MD
PRINCIPAL INVESTIGATOR
UC Davis Health
Frequently Asked Questions
Who can join the NCT07322133 clinical trial?
This trial is open to participants of all sexes, up to 28 Days, studying Hypotension and Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07322133 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07322133 currently recruiting?
Yes, NCT07322133 is actively recruiting participants. Contact the research team at solomontp@gmail.com for enrollment information.
Where is the NCT07322133 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT07322133 clinical trial?
NCT07322133 is sponsored by University of California, Davis. The principal investigator is Deepika Sankaran, MD at UC Davis Health. The trial plans to enroll 30 participants.