Dopamine versus norepinephrine for low blood pressure in newborns with pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, cluster-randomized pilot trial at UC Davis enrolling term and late‑preterm neonates with echocardiographic pulmonary hypertension, hypoxemic respiratory failure, and systemic hypotension that persists after a fluid bolus. Eligible infants on respiratory support and meeting blood pressure and oxygenation criteria are randomized to receive either dopamine or norepinephrine as first-line vasoactive therapy. The study measures short-term hemodynamic and oxygenation responses after initiation of the assigned vasopressor. The goal is to compare effects on systemic blood pressure and pulmonary vascular tone to inform choice of initial vasopressor in PPHN.

Why it matters

Who can join: the full rules

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

Where it's running

• UC Davis Children's Hospital
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Deepika Sankaran, MD — UC Davis Health
• Study coordinator: Solomon P Tatagiri, MBBS
• Email: solomontp@gmail.com
• Phone: 916-734-8672

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.