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Which score best predicts breathing trouble in newborns?

NCT ID NCT07183956

Knowledge-focused Sponsor: Muğla Sıtkı Koçman University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two scoring systems—the Silverman-Andersen score and the Downes score—to see which better predicts when a newborn with breathing problems will need a breathing tube. Researchers will follow 220 preterm and term infants receiving noninvasive breathing support. The goal is to find a more reliable way to assess breathing distress and guide treatment decisions.

What this could mean

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

What this could lead to
If successful, this study could help doctors more accurately predict which newborns need a breathing tube, potentially reducing unnecessary intubations and improving outcomes.
What could go wrong
This is an observational study, not a treatment trial. It only compares existing scoring methods, so it won't directly change care. Results may not apply to all hospitals or newborn groups.

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.

Participants

About 220 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

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.

Who is studied

Preterm infants born at \>28 weeks of gestation and term infants born at ≥37 weeks of gestation who developed respiratory distress within the first 6 hours after birth.

Ages

2 to 12 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: * Preterm infants born at \>28 weeks of gestation or term infants born at ≥37 weeks of gestation. * Development of respiratory distress within the first 6 hours after birth, defined as the presence of at least two of the following: Respiratory rate ≥60/min, Subcostal/intercostal retractions, Grunting. * Persistence of respiratory distress for more than 6 hours. * Age within the first 12 hours of life. * Silverman-Andersen score ≥3. * Receiving NIPPV support. Exclusion Criteria: * Major congenital malformations. * Airway or pulmonary anomalies. * Cardiovascular or respiratory instability due to sepsis. * Cyanotic congenital heart disease. * Severe intraventricular hemorrhage. * Contraindications for NIPPV therapy (e.g., congenital nasal anomalies, congenital diaphragmatic hernia, abdominal wall defects). * Requirement of intubation or chest compressions in the delivery room. * Requirement of intubation within the first hour of life. * Death within the first 24 hours of life. * Gestational age ≤28 weeks. * Diagnosis of air leak syndrome (pneumothorax) prior to initiation of NIPPV therapy.

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Conditions

The condition(s) this trial relates to.

Dyspnea Hyaline Membrane Disease neonatal respiratory failure newborn respiratory distress syndrome

As listed by the trial registrant

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

Intubation Noninvasive ventilation Respiratory distress neonatal Scoring systems

How to take part

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

  1. The places running it

    4 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

  • Akdeniz University School of Medicine, Department of Neonatology

    Antalya, Antalya, Turkey (Türkiye)

  • Antalya Training and Research Hospital, Department of Neonatology

    Antalya, Antalya, Turkey (Türkiye)

  • Mugla Training and Research Hospital, Department of Neonatology

    Muğla, Mentese, 48000, Turkey (Türkiye)

  • Sanliurfa Training and Research Hospital, Department of Neonatology

    Sanliurfa, Şanlıurfa, Turkey (Türkiye)

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