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Which drug works best for sick newborns? small trial aims to find out

NCT ID NCT07322133

Disease control Sponsor: University of California, Davis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This pilot study tests two medicines, dopamine and norepinephrine, in 30 full-term or near-term newborns with low blood pressure and lung problems caused by pulmonary hypertension. The goal is to see which drug better improves blood flow and oxygen levels. Results could help doctors choose the best first treatment for these fragile babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dopamine and norepinephrine
What this could lead to
If this trial shows one drug works better, it could guide doctors in choosing the best treatment for newborns with this serious condition.
What could go wrong
This is a small pilot study with only 30 babies, so results may not apply to all newborns. The drugs may also have side effects like affecting heart function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypotensive disorder persistent fetal circulation syndrome pulmonary hypertension respiratory failure Shock

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypotension and shock Hypoxemic respiratory failure Pulmonary hypertension of the newborn (PPHN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UC Davis Children's Hospital

    RECRUITING

    Sacramento, California, 95817, United States

More trials for these conditions

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