Effects of Transitional Circulation in ELBW Infants

• ClinicalTrials.gov Identifier: NCT02016599
• Recruitment Status: Active, not recruiting
• First Posted: December 20, 2013
• Last Update Posted: December 21, 2022
• Sponsor: University of Iowa
• Collaborators: National Institutes of Health (NIH); National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Danielle R Rios, University of Iowa

Tracking Information

• First Submitted Date: December 16, 2013
• First Posted Date: December 20, 2013
• Last Update Posted Date: December 21, 2022
• Actual Study Start Date: September 22, 2017
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2016)

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

Original Primary Outcome Measures (submitted: December 16, 2013)

Quantify the change in degree of systemic perfusion [ Time Frame: 7 days ]

Quantify the change in the degree of systemic perfusion prior to and after vasoactive medication usage.

Current Secondary Outcome Measures (submitted: November 12, 2019)

• Quantify cardiac output [ Time Frame: 7 days ]
  Quantify cardiac output during normal transitional circulation
• Quantify the differences in perfusion of end organs [ Time Frame: 7 days ]
  Quantify the differences in perfusion of end organs during transitional circulation
• Measure cardiopulmonary interaction patterns [ Time Frame: 1 year ]
  Measure cardiopulmonary interaction patterns during the transitional circulation and periods of hemodynamic instability to serve as forewarning of impending crisis
• Quantify the change in degree of systemic perfusion [ Time Frame: 7 days ]
  Quantify the change in the degree of systemic perfusion prior to and after vasoactive medication usage.

Original Secondary Outcome Measures (submitted: December 16, 2013)

• Quantify cardiac output [ Time Frame: 7 days ]
  Quantify cardiac output during normal transitional circulation, during hypotensive episodes, and while receiving vasoactive medications.
• Quantify the differences in perfusion of end organs [ Time Frame: 7 days ]
  Quantify the differences in perfusion of end organs during times of hemodynamic instability
• Measure cardiopulmonary interaction patterns [ Time Frame: 1 year ]
  Measure cardiopulmonary interaction patterns during the transitional circulation and periods of hemodynamic instability to serve as forewarning of impending crisis

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Transitional Circulation in ELBW Infants
• Official Title: Delineating the Effects of Transitional Circulation Physiology on Extremely Low Birth Weight (ELBW) Infants

Brief 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.

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:

1. Collect demographic (age, race, ethnicity) and labor/delivery information.
2. Perform serial physical exams to evaluate the infant's skin.
3. 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.
4. 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.
5. 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.
6. 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.
7. Measure the amount of blood flowing in one of the arteries in the brain using cerebral Doppler ultrasound
8. 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Blood samples will be taken to assess the lactate, troponin, and creatinine levels. These samples will be destroyed once analysis is complete.

• Sampling Method: Non-Probability Sample
• 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.

Condition

• Neonatal Prematurity
• Hypotension

Intervention

Other: Monitoring and biospecimen collection

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 Groups/Cohorts

• Initial cohort
  Initial cohort used to develop a series of multivariate clinical deterioration indices using monitoring modalities and biospecimen collection
  Intervention: Other: Monitoring and biospecimen collection
• Validation cohort
  Separate cohort of infants used to validate the clinical deterioration indices using monitoring modalities and biospecimen collection
  Intervention: Other: Monitoring and biospecimen collection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 15, 2016): 200
• Original Estimated Enrollment (submitted: December 16, 2013): 90
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Infant born at less than or equal to 1000 grams
• Admitted to NICU

Exclusion Criteria:

• Infant does not meet inclusion criteria
• Infant has life-threatening congenital defect
• Infant has congenital hydrops

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 1 Week (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02016599
• Other Study ID Numbers: 201911158; 1K23HL130522-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Danielle R Rios, University of Iowa
• Original Responsible Party: Danielle Rios, Baylor College of Medicine, Assistant Professor
• Current Study Sponsor: University of Iowa
• Original Study Sponsor: Baylor College of Medicine

Collaborators

• National Institutes of Health (NIH)
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Danielle R Rios, MD, MS; University of Iowa

• PRS Account: University of Iowa
• Verification Date: December 2022