Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Flow-synchronized Nasal IMV in Preterm Infants
NCT02085499 · View on ClinicalTrials.gov ↗
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 667 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02085499 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02085499?
The interventions under investigation include: non-synchronized NIMV (OTHER), Synchronized NIMV (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02085499?
This trial is sponsored by University of Miami, which has 667 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.