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NCT03058666 · ClinicalTrials.gov registry record · Phase 3

Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

A Phase 3 study, sponsored by ONY.

Completed
Registry status
Phase 3
Development phase
477
Enrollment target

NCT03058666: Completed Phase 3 study, sponsored by ONY.

NCT03058666 is a Phase 3 study that has completed, run by ONY. The registered enrollment target is 477 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03058666, a Phase 3 study, has completed, sponsored by ONY.

COMPLETED
Registry status
Phase 3
Development phase
477 participants
Enrollment target

Study Summary

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

Primary Outcome

Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.

Interventions

  • DRUG Aerosolized Calfactant
  • DEVICE Solarys

Trial Details

FieldValue
Enrollment Target 477 participants
Start Date 2017-03-29
Est. Completion 2018-07-31
Phase Phase 3
ONY

3 total trials

What the finished NCT03058666 record still lists

NCT03058666 is an interventional study that assigns participants to a tested intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 2 interventions - of which Aerosolized Calfactant is the first listed.

NCT03058666 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03058666 about?

NCT03058666 is a clinical study titled "Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients". Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

What is the current status of trial NCT03058666?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 477 participants. The study started on 2017-03-29. Estimated completion is 2018-07-31.

What interventions are being tested in trial NCT03058666?

The interventions under investigation include: Aerosolized Calfactant (DRUG), Solarys (DEVICE).

Who is sponsoring clinical trial NCT03058666?

This trial is sponsored by ONY, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03058666's enrollment target sits among peer trials

477 807th of 2000 higher than 1,193 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03058666, the US trial registry maintained by the National Library of Medicine. NCT03058666 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.