Effects of Transitional Circulation in ELBW Infants

NCT02016599 | Active Not Recruiting

• 2 other identifiers: 2019111581K23HL130522-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Prematurity; Hypotension

Keywords

Hypotension; Low blood pressure; Neonate; Extremely Low Birth Weight Infant

Outcome Measures

Primary Outcomes (1)

• 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

  7 days

Secondary Outcomes (4)

• Quantify cardiac output

  7 days

• Quantify the differences in perfusion of end organs

  7 days

• Measure cardiopulmonary interaction patterns

  1 year

• Quantify the change in degree of systemic perfusion

  7 days

Study Arms (2)

Initial cohort

Initial cohort used to develop a series of multivariate clinical deterioration indices using monitoring modalities and biospecimen collection

Other: Monitoring and biospecimen collection

Validation cohort

Separate cohort of infants used to validate the clinical deterioration indices using monitoring modalities and biospecimen collection

Other: Monitoring and biospecimen collection

Interventions

Monitoring and biospecimen collection OTHER

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.

Initial cohort; Validation cohort

Eligibility Criteria

• Age: Up to 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Infant has life-threatening congenital defect
• Infant has congenital hydrops

Sponsors & Collaborators

• University of Iowa: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Danielle R Rios, MD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: September 22, 2017
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)