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Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
NCT03277768 · View on ClinicalTrials.gov ↗
Study Summary
The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at \< 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.
Conditions Studied
Interventions
- DEVICE Resonance Raman Spectroscopy (RRS)
Study Locations (2)
Florida
- University of Florida — Gainesville
Massachusetts
- Boston Children's Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-05-01 |
| Est. Completion | 2018-08-23 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03277768
The ClinicalTrials.gov registry entry for NCT03277768 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,066 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Premature Infant appearing as the primary indexed condition, and to 1 intervention — of which Resonance Raman Spectroscopy (RRS) 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: NCT03277768 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Massachusetts. 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 NCT03277768 about?
NCT03277768 is a clinical study titled "Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.". The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at \< 30 weeks of gestation. The primary aim of this study is to...
What is the current status of trial NCT03277768?
This trial is currently completed. The enrollment target is 55 participants. The study started on 2015-05-01. Estimated completion is 2018-08-23.
What conditions does trial NCT03277768 study?
This clinical trial studies the following conditions: Premature Infant, Patent Ductus Arteriosus, Hemodynamic Instability. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03277768?
The interventions under investigation include: Resonance Raman Spectroscopy (RRS) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03277768?
This trial is sponsored by University of Florida, which has 1,066 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03277768 being conducted?
This trial has 2 study locations across Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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