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NCT02085499 · ClinicalTrials.gov registry record · NA
Flow-synchronized Nasal IMV in Preterm Infants
A NA study of Respiratory Insufficiency and Premature Infant Disease, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT02085499 is a NA study of Respiratory Insufficiency and Premature Infant Disease that has completed, run by University of Miami. The registered enrollment target is 11 participants, below the 750-participant average among 10 other Respiratory Insufficiency trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02085499, a NA study of Respiratory Insufficiency and Premature Infant Disease, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased. The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. This has been achieved by using techniques to detect the infant's spontaneous inspiration. The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to be determined. This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on ventilation and gas exchange in premature infants who require supplemental oxygen. The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and reduce breathing effort. The objective of the study is to compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.
Conditions Studied
Interventions
- OTHER non-synchronized NIMV
- OTHER Synchronized NIMV
Study Locations (1)
Florida
- Holtz Childrens Hospital-Jackson Health System-University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-03 |
| Est. Completion | 2018-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02085499
The ClinicalTrials.gov registry entry for NCT02085499 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 750-participant average among 10 other Respiratory Insufficiency trials with a reported enrollment target (99% lower). The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Respiratory Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which non-synchronized NIMV is the first listed.
NCT02085499 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02085499 about?
NCT02085499 is a clinical study titled "Flow-synchronized Nasal IMV in Preterm Infants". The use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased. The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is det...
What is the current status of trial NCT02085499?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2014-03. Estimated completion is 2018-06-01.
What conditions does trial NCT02085499 study?
This clinical trial studies the following conditions: Respiratory Insufficiency, Premature Infant Disease.
What interventions are being tested in trial NCT02085499?
The interventions under investigation include: non-synchronized NIMV (OTHER), Synchronized NIMV (OTHER).
Who is sponsoring clinical trial NCT02085499?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02085499 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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