New study asks: do all struggling newborns need breathing machines?
NCT ID NCT07390812
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This pilot study looks at whether full-term newborns with mild breathing problems can safely transition without a breathing tube called CPAP. Researchers will observe 22 babies born via scheduled C-section who show mild signs like flaring nostrils or light grunting. Half will receive standard CPAP care, while the other half will be monitored closely without it, only receiving CPAP if their condition worsens. The goal is to see if avoiding CPAP is safe and reduces complications like lung air leaks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transition without Continuous Positive Airway Pressure (CPAP)
- What this could lead to
- If successful, this could show that some newborns with mild breathing issues do not need CPAP, potentially reducing medical interventions and risks like pneumothorax.
- What could go wrong
- This is a very small early-phase pilot study with only 22 infants, so results may not apply broadly. The approach may fail if babies' breathing worsens without CPAP.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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22 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Dec 2026
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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37 to 41 weeks
- 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: * Full term infants (37 weeks + 0days to 41 weeks +6days gestational age) * Born via scheduled c-sections without labor * Who develop mild respiratory distress, defined as nasal flaring or, intermittent grunting, and/or mild retractions and/or +/- mild tachypnea ( respiratory rate 61-90). Exclusion Criteria: * Moderate to severe respiratory distress (continuous grunting, or moderate retractions or respiratory rate greater than 90 breaths per minute), * need for positive pressure ventilation (PPV) or advanced resuscitation in the first 5 minutes of life, * meconium stained amniotic fluid, * major congenital anomalies or chromosomal abnormalities.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hackensack Univeristy Medical Center
Hackensack, New Jersey, 07601, United States
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