Hypotension and Shock study: Dopamine administration vs Norepinephrine
Official title Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
ClinicalTrials.gov ID: NCT07322133
What this study is testing
What is Dopamine administration?
An investigational drug being studied as a potential treatment for hypotension and shock in term and late preterm neonates with pulmonary hypertension associated with hypoxemic respiratory failure. Dopamine is designed to stimulate dopamine receptors, which can increase heart contractility and raise blood pressure.
Also referred to as dopamine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how each drug affects blood pressure and oxygen levels right after it is started in these infants.
- Who it's for
- Term or late‑preterm babies who have pulmonary hypertension of the newborn and low systemic blood pressure.
- What's involved
- Infants will be randomly given either dopamine or norepinephrine, and doctors will monitor heart function, blood pressure, oxygen levels and other routine labs.
- Time commitment
- The trial lasts only the short hospital stay needed for the initial treatment, with daily monitoring and a few study visits.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 28
You may be able to join if
- 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...
You likely can't join if
- Gestational age \< 32 weeks
- Severe hypoxic respiratory failure (OI \> 35 or SpO2 \ 60 minutes)
- Lethal anomalies (e.g., trisomy 13 or 18)
- Complex congenital heart disease beyond specified criteria
The study team makes the final eligibility decision.
Where it is enrolling
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 28 days. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sacramento, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.