Neonatal PrematurityNCT02016599
Effects of Transitional Circulation in ELBW Infants
An observational study of Neonatal Prematurity and Hypotension, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 week
- Conditions the study is for
- Neonatal Prematurity, Hypotension
- What is being tested?
- Monitoring and biospecimen collection
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 week
- All sexes
- No healthy volunteers
- Child
Study population: All ELBW infants are eligible for enrollment. There will not be a placebo group. Data from the first 100 patients will be used to develop the clinical deterioration indices and data from the next 100 patients will be used to validate the indices.
Who may be able to join
- Infant born at less than or equal to 1000 grams
- Admitted to NICU
Who cannot join
- Infant does not meet inclusion criteria
- Infant has life-threatening congenital defect
- Infant has congenital hydrops
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delineating the Effects of Transitional Circulation Physiology on Extremely Low Birth Weight (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 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.
Read more
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.
Read the detailed description
Screening Phase: The subject's parents/guardians/legally authorized representative will be approached if the infant's birth weight makes them eligible for this research study.
Study Phase: During this study, we will use the monitoring methods normally used in the Neonatal Intensive Care Unit (NICU) and some new monitoring methods to find out all the changes that the infant's heart and lungs go through during the first week after delivery. During this period the study doctor and staff will:
- Collect demographic (age, race, ethnicity) and labor/delivery information.
- Perform serial physical exams to evaluate the infant's skin.
- Take several blood samples (2-3 drops per sample) to measure the lactate, troponin, and creatinine levels. These blood samples will be taken 1-4 times a day.
- Perform Echocardiograms (ultrasound of the heart) on a daily or more or less frequent basis. In between echocardiograms, we will monitor cardiac output with a non-invasive monitor using leads similar to those used for regular heart rate monitoring in the NICU. These tests are being done solely for research purposes and will be paid for by the study.
- Measure the amount of blood flow reaching the infant's brain and kidneys using a near-infrared spectroscopy (NIRS) machine. This test is being done solely for research purposes and will be paid for by the study.
- Perform Electrocardiograms (ECGs) to monitor how much blood flow is reaching the infant's heart. The sticky pads required for this test will be attached to the infant's chest as part of his/her routine care. For the purposes of this study, we will continuously monitor the machine to record the results.
- Measure the amount of blood flowing in one of the arteries in the brain using cerebral Doppler ultrasound
- Record results from any other monitoring tools the infant's doctor is using as part of his/her routine care. This will help us identify patterns that might lead to issues in premature babies. We will also be studying the effects of any medications the infant's doctor prescribes; especially those used for low blood pressure.
- Conditions
- Neonatal Prematurity, Hypotension
- Being tested
- Monitoring and biospecimen collection
- Keywords
- Hypotension, Low blood pressure, Neonate, Extremely Low Birth Weight Infant
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring and biospecimen collectionOther
The study team will use monitoring methods normally used in the NICU (physical exams, echocardiograms, and ECG) and some new monitoring methods (Near-infrared spectroscopy or NIRS) to find out all the changes that a baby's heart and lungs go through during the first week after delivery. In addition, blood samples will be taken to assess lactate, troponin, and creatinine levels.
| Study group | Role | What they receive |
|---|---|---|
| Initial cohort | Initial cohort used to develop a series of multivariate clinical deterioration indices using monitoring modalities and biospecimen collection Receives: Other: Monitoring and biospecimen collection | |
| Validation cohort | Separate cohort of infants used to validate the clinical deterioration indices using monitoring modalities and biospecimen collection Receives: Other: Monitoring and biospecimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify physiologic changes during transitional circulation
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
Measured: 7 days
Secondary outcomes (4)
Quantify cardiac output
Quantify cardiac output during normal transitional circulation
Measured: 7 days
Quantify the differences in perfusion of end organs
Quantify the differences in perfusion of end organs during transitional circulation
Measured: 7 days
Measure cardiopulmonary interaction patterns
Measure cardiopulmonary interaction patterns during the transitional circulation and periods of hemodynamic instability to serve as forewarning of impending crisis
Measured: 1 year
Quantify the change in degree of systemic perfusion
Quantify the change in the degree of systemic perfusion prior to and after vasoactive medication usage.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study start22 Sep 2017
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Danielle R Rios, University of Iowa
- Investigators
- Danielle R Rios, MD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016599
- Sponsor's protocol ID
- 201911158
- Other IDs
- 1K23HL130522-01
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2013
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delineating the Effects of Transitional Circulation Physiology on Extremely Low Birth Weight (ELBW) Infants
- ClinicalTrials.gov ID
- NCT02016599
- Acronym / sponsor ID
- 201911158
- Conditions
- Neonatal Prematurity, Hypotension
- Keywords
- Hypotension, Low blood pressure, Neonate, Extremely Low Birth Weight Infant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Screening Phase: The subject's parents/guardians/legally authorized representative will be approached if the infant's birth weight makes them eligible for this research study.
Study Phase: During this study, we will use the monitoring methods normally used in the Neonatal Intensive Care Unit (NICU) and some new monitoring methods to find out all the changes that the infant's heart and lungs go through during the first week after delivery. During this period the study doctor and staff will:
- Collect demographic (age, race, ethnicity) and labor/delivery information.
- Perform serial physical exams to evaluate the infant's skin.
- Take several blood samples (2-3 drops per sample) to measure the lactate, troponin, and creatinine levels. These blood samples will be taken 1-4 times a day.
- Perform Echocardiograms (ultrasound of the heart) on a daily or more or less frequent basis. In between echocardiograms, we will monitor cardiac output with a non-invasive monitor using leads similar to those used for regular heart rate monitoring in the NICU. These tests are being done solely for research purposes and will be paid for by the study.
- Measure the amount of blood flow reaching the infant's brain and kidneys using a near-infrared spectroscopy (NIRS) machine. This test is being done solely for research purposes and will be paid for by the study.
- Perform Electrocardiograms (ECGs) to monitor how much blood flow is reaching the infant's heart. The sticky pads required for this test will be attached to the infant's chest as part of his/her routine care. For the purposes of this study, we will continuously monitor the machine to record the results.
- Measure the amount of blood flowing in one of the arteries in the brain using cerebral Doppler ultrasound
- Record results from any other monitoring tools the infant's doctor is using as part of his/her routine care. This will help us identify patterns that might lead to issues in premature babies. We will also be studying the effects of any medications the infant's doctor prescribes; especially those used for low blood pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial cohort | – | Other: Monitoring and biospecimen collectionInitial cohort used to develop a series of multivariate clinical deterioration indices using monitoring modalities and biospecimen collection |
| Validation cohort | – | Other: Monitoring and biospecimen collectionSeparate cohort of infants used to validate the clinical deterioration indices using monitoring modalities and biospecimen collection |
Who may qualify
- Ages
- Up to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All ELBW infants are eligible for enrollment. There will not be a placebo group. Data from the first 100 patients will be used to develop the clinical deterioration indices and data from the next 100 patients will be used to validate the indices.
Key inclusion criteria (2 listed)
- Infant born at less than or equal to 1000 grams
- Admitted to NICU
Key exclusion criteria (3 listed)
- Infant does not meet inclusion criteria
- Infant has life-threatening congenital defect
- Infant has congenital hydrops
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring and biospecimen collectionThe study team will use monitoring methods normally used in the NICU (physical exams, echocardiograms, and ECG) and some new monitoring methods (Near-infrared spectroscopy or NIRS) to find out all the changes that a baby's heart and lungs go through during the first week after delivery. In addition, blood samples will be taken to assess lactate, troponin, and creatinine levels. | Other | Initial cohort, Validation cohort |
Primary outcome
Quantify physiologic changes during transitional circulation
Time frame: 7 days
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
4 secondary outcomes
Quantify cardiac output
Time frame: 7 days
Quantify the differences in perfusion of end organs
Time frame: 7 days
Measure cardiopulmonary interaction patterns
Time frame: 1 year
Quantify the change in degree of systemic perfusion
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle R Rios, MD, MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Prematurity and Hypotension, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify physiologic changes during transitional circulation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.