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NCT02294630 · ClinicalTrials.gov registry record · Phase 1
Aerosolized Surfactant in Neonatal RDS
A Phase 1 study of Respiratory Distress Syndrome, Newborn, sponsored by Sood, Beena G., MD, MS.
- Completed
- Registry status
- Phase 1
- Development phase
- 159
- Enrollment target
- 1
- Study location
NCT02294630: Completed Phase 1 study of Respiratory Distress Syndrome, Newborn, sponsored by Sood, Beena G., MD, MS.
NCT02294630 is a Phase 1 study of Respiratory Distress Syndrome, Newborn that has completed, run by Sood, Beena G., MD, MS. The registered enrollment target is 159 participants, below the 188-participant average among 8 other Respiratory Distress Syndrome, Newborn trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02294630, a Phase 1 study of Respiratory Distress Syndrome, Newborn, has completed, sponsored by Sood, Beena G., MD, MS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 159 participants
- Enrollment target
- 1
- Study location
Study Summary
Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants. Intratracheal instillation, the only approved means of surfactant delivery, requires endotracheal intubation and mechanical ventilation with their attendant risks. Interventions that decrease need for intubation and mechanical ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are increasingly being used for initial respiratory support in preterm neonates with RDS to improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar recruitment while obviating the risks of intubation and mechanical ventilation. The investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in preterm infants undergoing NIV is safe and feasible and will result in short-term improvement in oxygenation and ventilation. The objective of this proposal is to perform a single-center unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.
Primary Outcome
Since surfactant reflux is typically considered to be one of the most likely adverse events associated with the intervention, it was planned to report the number of participants specifically with surfactant reflux for this Outcome Measure
Conditions Studied
Interventions
- DRUG Surfactant
Study Locations (1)
Michigan
- Hutzel Women's Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2014-12 |
| Est. Completion | 2020-07 |
| Phase | Phase 1 |
What the finished NCT02294630 record still lists
NCT02294630 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 188-participant average among 8 other Respiratory Distress Syndrome, Newborn trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Respiratory Distress Syndrome, Newborn appearing as the primary indexed condition, and to 1 intervention - of which Surfactant is the first listed.
NCT02294630 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02294630 about?
NCT02294630 is a clinical study titled "Aerosolized Surfactant in Neonatal RDS". Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants. Intratracheal instillation, the only approved means of surfactant delivery, requires endotracheal intubation and mechanical ventilation with their attendant risks...
What is the current status of trial NCT02294630?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 159 participants. The study started on 2014-12. Estimated completion is 2020-07.
What conditions does trial NCT02294630 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Newborn.
What interventions are being tested in trial NCT02294630?
The interventions under investigation include: Surfactant (DRUG).
Who is sponsoring clinical trial NCT02294630?
This trial is sponsored by Sood, Beena G., MD, MS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02294630 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Respiratory Distress Syndrome, Newborn
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02294630's enrollment target sits among peer trials
159 4th of 8 higher than 5 of 8 other Respiratory Distress Syndrome, Newborn trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Distress Syndrome, Newborn 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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