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New treatment option for Surfactant Deficiency Syndrome Neonatal
Official title deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants
ClinicalTrials.gov ID: NCT07522346
What this study is testing
- What it's testing
- Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant replacement therapy.
- 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 24 to 32
You may be able to join if
- Born between 24 to 31+6 weeks' gestation, by best obstetric estimate
- Admitted to a participating NICU
- A parent/guardian who can provide informed consent
- Receiving CPAP respiratory support
- Planned to receive MIST by clinicians as standard clinical care
You likely can't join if
- Receiving any form of respiratory support other than CPAP
- Receiving more than 8 cmH2O PEEP via CPAP in the 4 hours prior to surfactant administration (except in the Delivery Room as part of resuscitation at...
- The infant's clinical team has concern regarding clinical stability and side effects of EIT
- The infant's skin integrity will not tolerate the EIT belt and gel
- Refusal of informed consent by their parent/guardian/legally acceptable representative
- The infant does not have a parent/guardian who can provide informed consent.
See the full eligibility criteria
- Born between 24 to 31+6 weeks' gestation, by best obstetric estimate
- Admitted to a participating NICU
- A parent/guardian who can provide informed consent
- Receiving CPAP respiratory support
- Planned to receive MIST by clinicians as standard clinical care
- Clinically stable (as determined by clinical team)
- Infant less than 72 hours of age
- MIST can be administered within 90 min of allocating assigned treatment arm
- Receiving any form of respiratory support other than CPAP
- Receiving more than 8 cmH2O PEEP via CPAP in the 4 hours prior to surfactant administration (except in the Delivery Room as part of resuscitation at birth)
- The infant's clinical team has concern regarding clinical stability and side effects of EIT
- The infant's skin integrity will not tolerate the EIT belt and gel
- Refusal of informed consent by their parent/guardian/legally acceptable representative
- The infant does not have a parent/guardian who can provide informed consent.
- Major congenital anomaly involving the cardiac, respiratory, gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes
- Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 24 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem...
- Suspected or confirmed air leak or pneumothorax
- Previous treatment with surfactant or mechanical ventilation via an endotracheal tube
- Urgent need for intubation and mechanical ventilation as determined by the treating clinician
- Not receiving full active intensive care (i.e. palliative/comfort care)
The study team makes the final eligibility decision.
Where it's taking place
- 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, 24 weeks to 32 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.