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NCT02016599 · ClinicalTrials.gov registry record
Effects of Transitional Circulation in ELBW Infants
A clinical trial of Hypotension and Neonatal Prematurity, sponsored by University of Iowa.
- Active
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT02016599: Active study of Hypotension and Neonatal Prematurity, sponsored by University of Iowa.
NCT02016599 is a study of Hypotension and Neonatal Prematurity that is active but no longer recruiting, run by University of Iowa. The registered enrollment target is 200 participants, above the 64-participant average among 12 other Hypotension trials with a reported enrollment target (213% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02016599, a study of Hypotension and Neonatal Prematurity, is active but no longer recruiting, sponsored by University of Iowa.
- ACTIVE NOT RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Develop a series of multivariate clinical deterioration indices which can be evaluated in real-time to provide continuous and calibrated measurements of likelihood of experiencing an outcome
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 |
What the registry record for NCT02016599 still lists
NCT02016599 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 64-participant average among 12 other Hypotension trials with a reported enrollment target (213% higher).
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.
NCT02016599 reports a single indexed study location in Iowa.
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.
What interventions are being tested in trial NCT02016599?
The interventions under investigation include: Monitoring and biospecimen collection (OTHER).
Who is sponsoring clinical trial NCT02016599?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02016599's enrollment target sits among peer trials
200 1st of 12 the highest of 12 other Hypotension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypotension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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