Trials / Completed
CompletedNCT04315636
Surfactant Nebulization for the Early Aeration of the Preterm Lung
Surfactant Nebulization for the Early Aeration of the Preterm Lung: a Single Blinded, Parallel, Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- University of Zurich · Academic / Other
- Sex
- All
- Age
- 3 Minutes
- Healthy volunteers
- Not accepted
Summary
Respiratory distress syndrome is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered via an endotracheal tube during mechanical ventilation. However, mechanical ventilation is considered an important risk factor for developing bronchopulmonary dysplasia. Surfactant nebulisation during noninvasive ventilation may offer an alternative method for surfactant administration and has been shown to be promising in terms of physiological as well as clinical changes. In preterm infants with respiratory distress syndrome, the effect of intratracheally administered surfactant on lung function during invasive ventilation has been studied extensively. However, the effect of early postnatal surfactant nebulization remains unclear. Therefore, the investigators plan to conduct a randomized controlled trial in order to investigate the effect of surfactant nebulization immediately after birth on early postnatal lung volume and short-term respiratory stability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Surfactant nebulisation | 200 mg/kg body weight nebulised surfactant (Poractant alfa, Chiesi Farmaceutici SpA, Parma, Italy) via a customised vibrating membrane nebuliser (eFlow neonatal nebuliser system, PARI Pharma, Starnberg). |
Timeline
- Start date
- 2021-03-19
- Primary completion
- 2021-11-01
- Completion
- 2022-01-16
- First posted
- 2020-03-19
- Last updated
- 2024-07-08
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04315636. Inclusion in this directory is not an endorsement.