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Single-blind randomized clinical trial in premature infants with Respiratory Distress Syndrome (RDS) eligible for treatment with exogenous surfactant identified early by lung ultrasonography.
EU CTIS ID: 2024-515641-42-00
What this study is testing
Compare the efficacy of two administration schemes of exogenous pulmonary surfactant in preterm newborns with Respiratory Distress Syndrome (one indicated based on lung ultrasound criteria versus the other following current guideline recommendations) in terms of reducing the number of intubations in the first 72 hours of life.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Premature newborns of both sexes, between 24 and 32 weeks and/or ≤ 1500 grams at birth, who do not meet any of the exclusion criteria, will be included.
You likely can't join if
- Lack of parental informed consent.
- Patients presenting with any of the following conditions: • Chromosomal abnormalities or complex congenital malformations.
- Patients presenting with any of the following conditions: Congenital lung diseases.
- Patients presenting with any of the following conditions: Severe sepsis or septic shock.
- Patients presenting with any of the following conditions: Meconium aspiration syndrome.
- Patients presenting with any of the following conditions: Administration of surfactant in the delivery room.
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.