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New study tests gentler way to give lung medicine to preterm infants

NCT ID NCT07350018

Disease control Sponsor: Uludag University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compares two medications (calfactant and poractant alfa) given through a thin tube to help premature babies breathe. The babies are born before 30 weeks and have respiratory distress syndrome. The goal is to see which drug works better at reducing the need for a breathing tube in the first 72 hours of life.

What this could mean

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

Active substance
surfactants (calfactant and poractant alfa)
What this could lead to
If this trial succeeds, it could show that one surfactant works better than the other when given through a thin tube, potentially improving breathing outcomes for premature babies without needing a breathing tube.
What could go wrong
This is a phase 4 study, so both treatments are already used in practice. The main risk is that the study may not find a clear difference between the two surfactants, or that the less invasive method may not work for all babies.

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 234 people

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

Started

Jan 2026

Expected to finish

Feb 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 6 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: * Born at a participating study center hospital. * Gestational age between 24 1/7 and 29 6/7 weeks (\<30 0/7 weeks). * Postnatal age within the first 6 hours of life. * Being on non-invasive respiratory support. * Presence of clinical and radiological findings consistent with respiratory distress syndrome (RDS). * Indication for surfactant therapy defined as a requirement for FiO₂ \>30% to achieve target oxygen saturation (SpO₂ 90-94%) while receiving noninvasive respiratory support with a minimum pressure of 6 cmH₂O. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Infants who were intubated for any reason before the decision to administer surfactant. * Severe birth asphyxia, defined as the need for advanced resuscitation after birth, 10th minute Apgar score ≤5, and arterial blood gas within the first hour of life showing pH \<7.0 and base excess (BE) ≤-12. * Presence of major congenital anomalies. * Respiratory distress due to causes other than respiratory distress syndrome (RDS). * Congenital heart disease. * Congenital diaphragmatic hernia. * Pulmonary hypoplasia. * Chromosomal abnormalities. * Presence of pneumothorax. * Lack of informed consent. * Neonatal seizures presence. * Postnatal age greater than 6 hours. * Infants born outside of gestational weeks 24 1/7 - 29 6/7. * Requirement for invasive mechanical ventilation at enrollment. * Infants receiving noninvasive respiratory support with an FiO₂ requirement \<0.30.

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome Premature Birth respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Respiratory distress syndrome (RDS) Respiratory distress syndrome in premature infants Surfactant

How to take part

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

  1. The places running it

    5 sites. 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

  • Bursa City Hospital

    RECRUITING

    Bursa, Turkey (Türkiye)

  • Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine

    RECRUITING

    Bursa, Turkey (Türkiye)

  • Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital

    RECRUITING

    Bursa, Turkey (Türkiye)

  • Dörtçelik Children's Diseases Hospital

    RECRUITING

    Bursa, Turkey (Türkiye)

  • Medicana Bursa Hospital

    RECRUITING

    Bursa, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.