Could lying on the stomach help infants breathe easier?
NCT ID NCT05002478
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial investigates whether placing infants with severe acute respiratory distress syndrome (ARDS) on their stomachs (prone positioning) after surfactant treatment can improve their oxygen levels. The study involves 14 mechanically ventilated infants, comparing oxygenation and lung imaging measurements in prone versus supine positions. The goal is to see if this simple positioning change could be a beneficial supportive therapy for these critically ill infants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prone positioning (turning the infant onto their stomach) after surfactant administration
- What this could lead to
- If prone positioning improves oxygenation in these infants, it could become a standard supportive care strategy for severe ARDS in this age group.
- What could go wrong
- This is a very small, early-stage trial (14 infants), so results may not apply broadly. Prone positioning has potential risks, such as pressure sores or accidental tube displacement, and may not improve outcomes for all infants.
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
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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
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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Up to 12 months
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patients hospitalized at Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) of the Medical University Vienna. * Patients aged \>36 weeks (corrected gestational age) and \<24 months. * Patient intubated and mechanically ventilated for at least 6 hours, with an expected requirement of invasive ventilatory support for at least 12 hours. * Clinical picture strongly suggestive for acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation and/or findings of new infiltrates consistent with acute pulmonary parenchymal disease on chest X-ray). * Severe pediatric acute respiratory distress syndrome (ARDS), defined by OSI ≥12.3 (wean FIO2 to maintain SpO2 ≤ 97% to calculate oxygen saturation index). * Written informed consent obtained from parents. Exclusion Criteria: * Clinical context * Need for O2 supplementation to maintain SpO2\>94% in the 4 weeks preceding hospitalization in the PICU/NICU * Cyanotic congenital heart disease Cardiogenic pulmonary edema * Severe pulmonary hypertension * Untreated pneumothorax * Severe neurological abnormalities * Other severe congenital anomalies such as congenital diaphragmatic hernia * Ongoing cardiopulmonary resuscitation or limitation of life support * Contradictions for prone positioning (adapted from Guerin, C., et al., Prone positioning in severe acute respiratory distress syndrome. N Engl J Med, 2013. 368(23): p. 2159-68): * Intracranial pressure \>30 millimeters of mercury (mmHg) in supine position or cerebral perfusion pressure \<60 mmHg * Massive hemoptysis requiring an immediate surgical or interventional radiology procedure * Tracheal surgery or sternotomy during the previous 15 days * Serious facial trauma or facial surgery during the previous 15 days * Deep venous thrombosis treated for less than 2 days * Cardiac pacemaker inserted in the last 2 days * Unstable spine, femur, or pelvic fractures * Use of extracorporeal membrane oxygenation (ECMO) before inclusion * Lung transplantation * Burns on more than 20% of the body surface * Other non-inclusion criteria * Indication not to attempt resuscitation * Patient already recruited for other clinical studies * Patients who already received surfactant in the last 4 weeks * Thoracic skin lesions or wounds on the thorax, where the EIT-electrode-belt would be placed
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Medical University of Vienna
RECRUITINGVienna, 1090, Austria
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