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NCT01116921 · ClinicalTrials.gov registry record · NA
Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT01116921: Completed NA study, sponsored by University of Minnesota.
NCT01116921 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 103 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116921, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study Summary
The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.
Primary Outcome
"Treatment Failure" criteria were the same for both groups. "Treatment Failure" required two of the following: 1) FiO2 \>40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 \>65mmHg on ABG/CBG or \>70 on VBG, or 3) pH\<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 \>40%, or 4) deemed necessary by medical provider.
Interventions
- DEVICE Nasal continuous positive airway pressure (nCPAP)
- DEVICE Laryngeal Mask Airway (LMA) to deliver surfactant
- DRUG Surfactants, Pulmonary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01116921 record still lists
NCT01116921 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Nasal continuous positive airway pressure (nCPAP) is the first listed.
NCT01116921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116921 about?
NCT01116921 is a clinical study titled "Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates". The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) w...
What is the current status of trial NCT01116921?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2011-02. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01116921?
The interventions under investigation include: Nasal continuous positive airway pressure (nCPAP) (DEVICE), Laryngeal Mask Airway (LMA) to deliver surfactant (DEVICE), Surfactants, Pulmonary (DRUG).
Who is sponsoring clinical trial NCT01116921?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01116921's enrollment target sits among peer trials
103 837th of 2000 higher than 1,164 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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