Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
90

Summary

Conditions
  • Hypotension
  • Neonatal Prematurity
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Younger than 1 years
Gender
Both males and females

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) ...

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.

Tracking Information

NCT #
NCT02016599
Collaborators
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Danielle R Rios, MD, MS University of Iowa