Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A… (NCT04056741) | Clinical Trial Compass
SuspendedPhase 2
Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study
Stopped: alteration of study required
United States55 participantsStarted 2025-02-07
Plain-language summary
A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.
Who can participate
Age range
24 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Gestational age at the time of enrollment ≥ 24 0/7 weeks
* Weight at the time of enrollment 500- 5000 grams
* Age ≤ 24 hours old
* Require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation)
* Require FiO2 ≤ 40%
* Clinical diagnosis of RDS
Exclusion Criteria:
* Prior surfactant administration
* Prior mechanical ventilation
* Major congenital anomaly
* Abnormality of the airway
* Respiratory distress secondary to an etiology other than RDS (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
* Apgar score \< 5 at 5 minutes of age
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Instillation failures
Timeframe: First 10 minutes after surfactant instillation.