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Ultrasound may help doctors time lifesaving lung treatment for preterm infants

NCT ID NCT06446453

Diagnosis Sponsor: Connecticut Children's Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether using a lung ultrasound score can help doctors decide when to give surfactant therapy to premature infants with respiratory distress syndrome. Surfactant is a substance that helps babies' lungs stay open, but giving it too late can reduce its benefit. The trial will compare ultrasound-guided treatment decisions with current standard guidelines in 52 preterm infants born between 27 and 36 weeks of gestation. The goal is to see if this approach leads to earlier treatment and better breathing outcomes.

What this could mean

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

Active substance
surfactant therapy guided by lung ultrasound score
What this could lead to
If successful, this approach could help doctors give surfactant earlier to premature babies with breathing problems, potentially improving their short-term recovery.
What could go wrong
This is a small, early-stage study (52 infants) comparing a new ultrasound-guided method to current guidelines. The results may not apply to all preterm infants or settings.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 52 people

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

Started

Jun 2024

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

0 to 2 hours

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: * The infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study * Birth gestational age between 27w0d-36w6d * Diagnosis of respiratory failure secondary to RDS requiring respiratory support with non-invasive positive pressure ventilation Exclusion Criteria: * Unable to obtain lung ultrasound between 1-2 hours of life * Infants already intubated or received surfactant before the point of care lung ultrasound * Infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations * Infants born with chromosomal abnormalities * Infants with APGARs ≤ 5 at 10 minutes of life * Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

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

Intensive care units, neonatal Pulmonary surfactants Respiratory distress syndrome, newborn

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

  • Connecticut Children's

    RECRUITING

    Hartford, Connecticut, 06106, United States

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