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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 28 Days
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares dopamine and norepinephrine as the first medicines used to raise low blood pressure in newborns. It is for babies born at or near full term who have high blood pressure in the lungs, trouble getting enough oxygen, and low blood pressure in the body. The study checks short-term changes in blood flow and oxygen levels.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age since the start of pregnancy plus time since birth is over 34 weeks and 6 days; the baby is no more than 28 days old.
  • Needs a breathing machine or other breathing support and at least 30% oxygen. If using high-flow oxygen through the nose, the flow must be at least 2 liters per minute.
  • A heart ultrasound shows high blood pressure in the lungs.
  • Average blood pressure stays below the cutoff for the baby's age at birth, even after getting 10–20 milliliters of fluid per kilogram of body weight.
  • Babies may have a hole in the muscle below the lungs, Down syndrome, or brain injury from low oxygen being treated with cooling.
  • Some heart openings are allowed: PDA, PFO, or ASD. A VSD, a hole between the heart's lower chambers, must be smaller than 2 millimeters.

Who can't join

  • Born before 32 weeks of pregnancy.
  • Very severe trouble getting oxygen: an oxygenation index score above 35, or blood oxygen below 75% while receiving 100% oxygen for more than 60 minutes.
  • A condition present at birth that is expected to cause death, such as trisomy 13 or 18.
  • A complex heart defect present at birth beyond the types allowed in this study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA