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New treatment option for Neonatal Respiratory Distress
Official title DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)
ClinicalTrials.gov ID: NCT07513051
What this study is testing
- What it's testing
- The hypothesis behind the study is that the performance of constant flow CPAP (Continuous Positive Airway Pressure) devices (CF-CPAP) is not inferior to that of variable flow CPAP devices (VF-CPAP) in terms of respiratory efforts assessed by swing EAdi (Electrical activity of diaphragm) in a population of premature neonates born ≤ 32 weeks of gestational age.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 72 to 10
You may be able to join if
- Above mentioned age limits (72 hours to 10 weeks) apply to postnatal age. apply to gestational age at birth and postmenstrual age (in weeks).
- Neonates born at ≤ 32 weeks GA (gestational age)
- Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit)
- Receiving CPAP since \> 24 hours at inclusion
- Equipped with EAdi catheters.
See the full eligibility criteria
- Above mentioned age limits (72 hours to 10 weeks) apply to postnatal age. apply to gestational age at birth and postmenstrual age (in weeks).
- Neonates born at ≤ 32 weeks GA (gestational age)
- Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit)
- Receiving CPAP since \> 24 hours at inclusion
- Equipped with EAdi catheters.
- Aged more than 72 hours
- With parental consent
- Affiliated to or benefiting from a social security system Non
- More than 1 episode of apnea / hour and/or hypercapnic acidosis (defined as pH \ 65)
- FiO2 \> 60%
- Neonatal ARDS (acute respiratory distress syndrome) according to the Montreux definition
- Pneumothorax/ pneumomediastinum
- Nasal lesions contraindicating nasal noninvasive ventilation
- Major congenital malformation/Chromosomopathies
- Congenital neuromuscular diseases
- Hemodynamic instability
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 72 hours to 10 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.