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Gentler breathing support may help preterm babies avoid breathing tubes

NCT ID NCT07693530

Disease control Sponsor: Kayseri City Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
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.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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)
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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
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Status unknown
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First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial compares two noninvasive breathing support methods—heated humidified high-flow nasal cannula (HHHFNC) and nasal continuous positive airway pressure (nCPAP)—in premature infants (born at 28-34 weeks) with moderate respiratory distress syndrome. The goal is to see which method better prevents the need for a breathing tube and mechanical ventilation in the first week of life. The study also tracks side effects like nasal injury and infections.

What this could mean

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

Active substance
Heated humidified high-flow nasal cannula (HHHFNC) and nasal continuous positive airway pressure (nCPAP)
What this could lead to
If one method works better, it could reduce the need for invasive breathing tubes in premature babies, lowering risks of injury and infection.
What could go wrong
This is a small, single-center trial, so results may not apply to all hospitals. Both methods are already used, so the difference may be small.

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

86 people

The number who actually took part.

Started

Jun 2020

Finished

May 2022

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

28 to 34 weeks

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 admitted to the NICU who fulfilled all of the following were eligible: 1. Gestational age (GA) 28+0 to 34+6 weeks and/or birth weight 1,000-2,000 g 2. Clinical and radiological diagnosis of moderate respiratory distress syndrome (RDS) 3. Silverman-Anderson score (SAS) 4 \< SAS \< 7 4. Eligibility for noninvasive ventilatory support Exclusion Criteria: 1. Parental refusal of consent 2. Outborn infants transferred from other centers 3. Infants who required immediate intubation in the delivery room 4. Major congenital anomalies, chromosomal disorders, gastrointestinal malformations, or life-threatening congenital cardiac defects 5. Nasal/pharyngeal anatomical anomalies (choanal atresia, cleft palate/lip) 6. Moderate-to-severe hypoxic-ischemic encephalopathy (Grade 2-3) 7. Infants who died unexpectedly shortly after admission without respiratory evaluation

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Premature Birth Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

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

Premature birth Respiratory distress syndrome, newborn

Contacts and locations

Locations

  • Kayseri City Hospital

    Kayseri, Kayseri, 38090, Turkey (Türkiye)

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