An observational study in Premature Infant, Chronic Respiratory Disease and Neuromuscular Diseases, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 14 Days to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-13.
Sponsored by University of Colorado, Denver · Observational
Among 741 studies in Premature Birth with a site in United States — 103 open to participants now, 135 under way, 9 of them phase 3. Premature Birth · United States.
Among the 741 studies in Premature Birth with a site in United States, this one is the 115th largest by planned enrollment of the 209 observational ones that give a count, is one of 41 that started in 2019, is one of 209 observational ones, reaches primary completion later than 44 of the 134 other live ones, and was the 524th registered.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
Browse Premature Birth studies →103 of the 741 studies in Premature Birth with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
University of South Carolina · Sites in United States
Columbia University · Sites in United States
University of Alabama at Birmingham · Sites in United States
The University of Texas Medical Branch, Galveston · Sites in United States
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 313 Premature Birth studies recruiting now, 87 (28%) set no upper age limit and 222 (71%) stop at 75 or younger; 239 take children under 18; 105 take healthy volunteers.
This study: 14 Days to 40 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
741 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. 41 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Median enrollment 86 across the 528 interventional studies, 104 across the 209 observational. Of the 542 that completed or were terminated, 145 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
74 of 741 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 4 studies filed under Premature Birth — fewer than ten, so there is no comparison to draw.
47 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 |
| NCT07060911Neola Medical IncPivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates | 2026-12 |
Among the 741 studies in Premature Birth with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.
The purpose of this study is to evaluate EIT for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls.
Researchers will use EIT to determine changes in regional ventilation with pulmonary interventions including airway clearance and invasive and noninvasive ventilation in a pediatric respiratory disease population.
pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. Populations who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Premature infants \>1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection
Participants ages \>1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease
Participants ages 21-40 years with confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of Duchenne muscular dystrophy (DMD) or other diagnoses associated with mild cardiomyopathy
Age and height matched healthy controls
Adults or children who are having or have recently had a V/Q scan
Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia
Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis
EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung.
These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified.
Time frame: 24 months
Regional conductivity changes due to ventilation
Describe regional ventilation in pediatric respiratory disease populations including neuromuscular weakness, skeletal/chest wall disorders, and chronic airway and parenchymal lung disease including bronchopulmonary dysplasia. This is a qualitative aim and will summarize EIT images pictorially. Pixel densities will be evaluated for normality and summarized as mean (SD) or median (interquartile range). EIT images will be qualitatively compared between cases and controls.
Time frame: 24 months
Waveform for a mesh element
Time-series waveform indicated by time in seconds compared to Recon signal (au).
Time frame: 24 months
Regional conductivity changes due to perfusion
This is a qualitative and quantitative aim. Results will qualitatively compare EIT images with CXR and CT scan images when available. Images will be displayed side by side and interpreted by both the clinician and the EIT study staff. Various summary measures of EIT outcomes will be calculated including pixel heterogeneity, summary changes over tidal breath and variation between tidal peaks. Pearson and Spearman correlation will be calculated between summary EIT outcomes and continuous primary clinical values. Linear and logistic regression will be used to estimate associations (with 95% CI) between EIT measures and clinical outcomes. Summary data will be presented in tables and figures using basic descriptive statistics stratified by study group.
Time frame: 24 months
Regional pulsatile perfusion imaging at the end of systole
Time frame: 5 minutes
Power waveform (computed as the inner product of measured voltages and applied currents)
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2019 (actual). Primary completion is estimated for Nov 2026, 90 months after the start.
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 planned 90 months is above 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.
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University of Colorado, Denver →