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Effects of Transitional Circulation in ELBW Infants
NCT02016599 · View on ClinicalTrials.gov ↗
Study Summary
Prematurity is a very important problem in this country. Prematurity can cause problems with organ (such as the brain, heart, kidneys) growth and development. A very important part of keeping premature babies healthy is ensuring good blood flow to all of these organs. Some premature babies have problems with their hearts and getting enough blood out to the rest of their bodies. This problem is referred to as hypotension (low blood pressure) and is found by looking at blood test values and while examining the baby. These babies will need medications to help their heart deliver blood to all of the important areas in their bodies. Babies who have hypotension requiring medications tend to have more problems than premature babies that don't need hypotension medication. Some of these problems include a higher risk of bleeding into their brain, kidney problems, liver problems, intestinal (gut) problems causing difficulty tolerating feeds, and a very dangerous infection of their intestines. Some long term effects include hearing loss, developmental delay, and learning problems in the future that are worse than other premature babies who did not have hypotension. Hypotensive premature babies also have a higher risk of death. The cause of hypotension in the first week of life is still not known. We know that babies have to get used to being in the outside world instead of in the womb. A lot of changes with the heart and lungs have to happen for them to not be affected by that transition. If we could gain a better understanding of those changes, we might be able to prevent some of these issues from happening. This study will look closely at premature babies with and without hypotension to assess the heart and lung changes in the first week of life. To do this, we will use monitoring machines and tests to get a better idea of all the changes that happen. This information will help all neonatologists who care for premature babies.
Conditions Studied
Interventions
- OTHER Monitoring and biospecimen collection
Study Locations (1)
Iowa
- University of Iowa — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-09-22 |
| Est. Completion | 2026-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02016599
The ClinicalTrials.gov registry entry for NCT02016599 describes a study currently listed as active not recruiting. 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 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 156 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 Hypotension appearing as the primary indexed condition, and to 1 intervention — of which Monitoring and biospecimen collection 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: NCT02016599 reports 1 study location spanning 1 distinct geographic area — top geographies include Iowa. 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 NCT02016599 about?
NCT02016599 is a clinical study titled "Effects of Transitional Circulation in ELBW Infants". Prematurity is a very important problem in this country. Prematurity can cause problems with organ (such as the brain, heart, kidneys) growth and development. A very important part of keeping premature babies healthy is ensuring good blood flow to all of these organs. Some premature babies have pro...
What is the current status of trial NCT02016599?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2017-09-22. Estimated completion is 2026-12.
What conditions does trial NCT02016599 study?
This clinical trial studies the following conditions: Hypotension, Neonatal Prematurity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02016599?
The interventions under investigation include: Monitoring and biospecimen collection (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02016599?
This trial is sponsored by University of Iowa, which has 156 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02016599 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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