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New treatment option for Respiratory Distress Syndrome, Newborn
Official title Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
ClinicalTrials.gov ID: NCT07251790
What this study is testing
- What it's testing
- Many babies born very preterm (\<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 and older
You may be able to join if
- The infant is admitted to participating NICU
- The infant is born between 22+0 to 29+6 weeks gestational age
- The infant has been on a form of invasive mechanical ventilation for at least 4 hours
- The infant is being electively extubated for the first time from invasive mechanical ventilation to nCPAP
- The infant is clinically stable (as per clinical and research team consensus)
You likely can't join if
- The infant is born \ 30 weeks gestational age
- The infant has a major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis...
- The infant has severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that...
- The infant is receiving invasive mechanical ventilation via nasotracheal intubation
- The infant is planned for extubation to any other mode of non-invasive respiratory support than nCPAP, or no respiratory support
- Refusal of informed consent from the parent(s), or the infant does not have a guardian who can provide informed consent.
See the full eligibility criteria
- The infant is admitted to participating NICU
- The infant is born between 22+0 to 29+6 weeks gestational age
- The infant has been on a form of invasive mechanical ventilation for at least 4 hours
- The infant is being electively extubated for the first time from invasive mechanical ventilation to nCPAP
- The infant is clinically stable (as per clinical and research team consensus)
- The parent(s) or legal guardian(s) provides prospective informed consent.
- The infant is born \ 30 weeks gestational age
- The infant has a major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes
- The infant has severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major...
- The infant is receiving invasive mechanical ventilation via nasotracheal intubation
- The infant is planned for extubation to any other mode of non-invasive respiratory support than nCPAP, or no respiratory support
- Refusal of informed consent from the parent(s), or the infant does not have a guardian who can provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
- Saint Albans, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 0 hours and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia; Saint Albans, Victoria, Australia. 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.