Tiny study tests smarter ventilator for babies born with diaphragm defect
NCT ID NCT03250793
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This pilot study looked at 8 newborns with congenital diaphragmatic hernia (a hole in the diaphragm) after surgery. Researchers compared two types of breathing machines: standard ventilation and a newer method called NAVA, which senses the baby's own breathing signals to provide synchronized support. The goal was to measure how hard the babies had to work to breathe with each machine, using a small pressure sensor in the esophagus. This early study aims to understand the physiology before testing if NAVA leads to better outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NAVA (Neurally Adjusted Ventilatory Assist) ventilation and conventional pressure-controlled ventilation
- What this could lead to
- If successful, this study could provide physiological evidence to support using NAVA ventilation to improve breathing mechanics in newborns with CDH, potentially reducing ventilation duration and complications.
- What could go wrong
- This is a very small pilot study with only 8 participants, so results may not apply to all newborns. It measures short-term breathing effort, not long-term outcomes like survival or hospital stay.
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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8 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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Jan 2021
- 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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1 year and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Neonate admitted to neonatal intensive care beyond 34 weeks of amenorrhea * With a diagnosis of congenital diaphragmatic hernia having undergone a repair surgery. * Necessary invasive ventilatory support by conventional ventilation * Informed and signed consent of parents (and / or holders of parental authority) Exclusion Criteria: * Refusal of parents (and / or holders of parental authority) to participate in the study * Contra-indication to the use of an oro or naso-gastric tube (oesophageal surgery) * Child at risk of poor tolerance to the placement of the oesophageal pressure transducer (history of discomfort when placing a tube, weight \<1500g) * Central or neuromuscular neurological pathology which may affect respiratory control
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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.
Contacts and locations
Locations
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Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
Bron, 69500, France
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Other studies related to the condition(s) this trial covers.