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NCT01042600 · ClinicalTrials.gov registry record · Phase 4
Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation
A Phase 4 study of Respiratory Distress Syndrome, Newborn, sponsored by Albany Medical College.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT01042600: Completed Phase 4 study of Respiratory Distress Syndrome, Newborn, sponsored by Albany Medical College.
NCT01042600 is a Phase 4 study of Respiratory Distress Syndrome, Newborn that has completed, run by Albany Medical College. The registered enrollment target is 61 participants, below the 200-participant average among 8 other Respiratory Distress Syndrome, Newborn trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01042600, a Phase 4 study of Respiratory Distress Syndrome, Newborn, has completed, sponsored by Albany Medical College.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to nasal CPAP, after surfactant is given. The primary outcome measure is the rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a) early, if the baby is unable to be placed back on CPAP (needs mechanical ventilation) or, b) late, if the baby requires retreatment with surfactant within 8 hours or more than 2 doses of surfactant. The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA, while achieving comparable efficacy of surfactant treatment. The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation, when compared with standard surfactant treatment following sedation and endotracheal intubation.
Conditions Studied
Interventions
- DEVICE Endotracheal tube insertion
- DEVICE Laryngeal mask airway insertion
Study Locations (1)
New York
- Albany Medical Center - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
What the finished NCT01042600 record still lists
NCT01042600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 200-participant average among 8 other Respiratory Distress Syndrome, Newborn trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Respiratory Distress Syndrome, Newborn appearing as the primary indexed condition, and to 2 interventions - of which Endotracheal tube insertion is the first listed.
NCT01042600 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01042600 about?
NCT01042600 is a clinical study titled "Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation". In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to surfactant delivery via lary...
What is the current status of trial NCT01042600?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2009-12. Estimated completion is 2012-11.
What conditions does trial NCT01042600 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Newborn.
What interventions are being tested in trial NCT01042600?
The interventions under investigation include: Endotracheal tube insertion (DEVICE), Laryngeal mask airway insertion (DEVICE).
Who is sponsoring clinical trial NCT01042600?
This trial is sponsored by Albany Medical College, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01042600 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01042600's enrollment target sits among peer trials
61 6th of 8 higher than 3 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.
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