An observational study in Premature Infant, Patent Ductus Arteriosus and Hemodynamic Instability, sponsored by University of Florida. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by University of Florida · Observational
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Among 742 studies in Premature Birth with a site in United States — 104 open to participants now, 136 under way, 9 of them phase 3. Premature Birth · United States.
Among the 742 studies in Premature Birth with a site in United States, this one is the 144th largest by enrollment of the 209 observational ones that give a count, is one of 36 that started in 2015, is one of 209 observational ones, and was the 458th registered.
2,554 studies on the registry are indexed under Premature Birth; 503 are open to participants now.
Browse Premature Birth studies →104 of the 742 studies in Premature Birth with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 0 days–9 mo
University of South Carolina · Sites in United States
Ages 18+ · Women only
Columbia University · Sites in United States
Ages 18–40 · Women only
University of Alabama at Birmingham · Sites in United States
Ages 1 days–3 days
The University of Texas Medical Branch, Galveston · Sites in United States
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: all sexes.
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742 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 49 · Phase 2 68 · Phase 3 66 · Phase 4 23
First in 1987; this study’s year is marked. 36 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 55 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Median enrollment 85 across the 529 interventional studies, 104 across the 209 observational. Of the 542 that completed or were terminated, 145 (27%) have results posted.
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74 of 742 have an industry lead sponsor. The 10 most frequent:
University of Florida is the lead sponsor of 1,288 studies on the registry; 200 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
University of Florida has 7 studies filed under Premature Birth — fewer than ten, so there is no comparison to draw.
46 of the studies in Premature Birth with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04614714Phase 3University of California, DavisMilk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants | 2027-08-30 |
| NCT03797183University of Colorado, DenverGenesis Electrical Impedance Tomography (EIT): A Preliminary Study | 2026-11 |
| NCT04372953Murdoch Childrens Research InstitutePositive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). | 2026-11-30 |
| NCT01483079Baylor College of MedicinePost-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU) | 2026-12 |
| NCT07674953University of ArkansasHow Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants | 2026-12 |
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Among the 742 studies in Premature Birth with a site in United States, from their registry updates:
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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.
Premature infants born \<30 weeks gestational age and admitted to the Boston Children's Hospital neonatal intensive care unit (NICU), Brigham and Women's NICU, and the University of Florida NICU.
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Exclusion Criteria:
Device: Resonance Raman Spectroscopy (RRS)
Device: Resonance Raman Spectroscopy (RRS)
Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.
Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.
Time frame: Up to a maximum of 14 data collection times
Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.
RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event.
Time frame: Up to a maximum of 14 data collection times
Plan to share: No — The analysis of the data will be shared with other research. Individual patient data will not be shared.
No publications or documents are linked to this record.
Ran from May 2015 to primary completion in Sep 2017, 28 months.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's 28 months is below that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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