New treatment option for Respiratory Distress Syndrome in Premature Infant
Official title Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
ClinicalTrials.gov ID: NCT07098910
What this study is testing
- What it's testing
- Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS).
- Time commitment: about 12 months
- 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 up to 48
You may be able to join if
- Inborn neonate (=born in the hospital), AND
- Gestational age \<34+0 weeks, AND
- Birth weight ≥750g, AND
- Age \<48 hours, AND
- Diagnosis of RDS, confirmed with a chest x-ray or lung ultrasound, except in cases where immediate treatment is necessary and imaging would cause a...
You likely can't join if
- Severe respiratory insufficiency in need of intubation at delivery room
- Severe respiratory insufficiency in need of intubation and invasive mechanical ventilation after arrival to NICU
- Previous surfactant administration
- Previous invasive mechanical ventilation
- Known pneumothorax
- Major malformations
See the full eligibility criteria
- Inborn neonate (=born in the hospital), AND
- Gestational age \<34+0 weeks, AND
- Birth weight ≥750g, AND
- Age \<48 hours, AND
- Diagnosis of RDS, confirmed with a chest x-ray or lung ultrasound, except in cases where immediate treatment is necessary and imaging would cause a delay AND
- Indication for surfactant treatment: Infant on non-invasive support (CPAP/NIPPV) and FiO2 \>0.30 to maintain oxygen saturation (SpO2) between 90% and 95%
- Severe respiratory insufficiency in need of intubation at delivery room
- Severe respiratory insufficiency in need of intubation and invasive mechanical ventilation after arrival to NICU
- Previous surfactant administration
- Previous invasive mechanical ventilation
- Known pneumothorax
- Major malformations
- Physician not confident with study intervention
- The physician decided not to include the patient due to a preference for performing INSURE
- Excluded due to time constraints preventing completion of informed consent and trial procedures
The study team makes the final eligibility decision.
Where it's taking place
- Hanoi, Vietnam
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, up to 48 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanoi, Vietnam. 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.