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Efficacy and safety of the intratracheal administration of budesonide with surfactant in very preterm infants to prevent bronchopulmonary dysplasia: randomized clinical trial.
EU CTIS ID: 2024-519980-16-00
What this study is testing
To evaluate the efficacy of endotracheal administration of budesonide combined with porcine pulmonary surfactant on the incidence of bronchopulmonary dysplasia (BPD) in preterm newborns ≤32 weeks of gestational age. - To evaluate the efficacy of endotracheal administration of the budesonide-porcine pulmonary surfactant mixture by comparing ultrasound markers (lung aeration score) and biological markers of inflammation (IL-6 concentration in nasopharyngeal aspirate) at 7 days of life between patients treated with budesonide and surfactant and those who received only surfactant. - To evaluate the safety of endotracheal administration of the budesonide-porcine pulmonary surfactant mixture.
- Therapeutic confirmatory (Phase III)
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
- All preterm newborns ≤32 weeks of gestational age, regardless of their birth weight, who are admitted to the Neonatal Unit, and whose parents/legal representative have signed the informed consent.
You likely can't join if
- Congenital malformations of the upper airway, hydrops, chromosomal abnormalities, neuromuscular disease, or patients admitted to palliative care.
- Patients transferred from another center who have received the first dose of endotracheal surfactant at the originating hospital.
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.