Detection and Quantification of Neonatal Intraventricular Hemorrhage
Condition: Intraventricular Brain Hemorrhage
MeSH terms: Intracranial Hemorrhages; Hemorrhage
Study type: Observational

Summary: 
      Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add
      to information needed to diagnose neurological problems in infants - both preterm and term.
      The investigators propose a method to test these technologies in the preterm population to
      determine its safety and ease of use. The investigators will test on preterm infants of 30-34
      weeks gestation, starting first with the older infants (32-34 weeks) then moving down to the
      smaller population (30-32 weeks). In both groups the investigators will start with a short
      time period and gradually extend the time as safety is established.

      All studies will be conducted at Shands Teaching Hospital at the University of Florida.
    

Detailed description: 
      We propose to start with infants 32-34 weeks of gestation. Within this group, we will test
      the electrodes for increasing lengths of time. The first group will have the electrodes in
      place for 10 minutes. After doing this on two separate infants without issue, the length of
      time will increase to 1 hour, 4 hours, and end with 8 hours. To move up to the next time
      increment, safety will be documented in two infants. In all of the time groups tested we will
      enroll 2 infants, but with the final time group of 8 hours we will aim for 5 infants. Infants
      will be tested within the first 5 days of life. The neonate's gestational age will be
      recorded and the neonate assigned a study number. Information about the ease of use of the
      device, how it was fitted, and any effects it had on the skin. In addition, the head
      circumference, and the birth weight or weight at time of application will be collected. This
      will be the only medical information collected.

      After this group has been completed, we will enroll 30-32 week infants and follow the same
      protocol of time increments, with the same numbers needed to move up, and also with the goal
      of 5 infants in the final group of 8 hours.

      There will be a nursing evaluation form for the bedside nurse to complete accessing skin
      integrity and erythema after device removal, and also ease of use, and possible interference
      with cares and other devices. One clinical nurse will be the sole person placing and removing
      the net but the bedside nurse and will still do an evaluation evaluating the skin under and
      around the dense array every 30 minutes. The neonates head will be turned every 30 minutes
      following the skin check to avoid pressure injury related to the array. A brief optional
      questionnaire will be given to the bedside nurse to validate that the device did not
      interfere with the bedside nursing care (see questionnaire).

      Inclusion criteria will be infants 30-34 weeks gestation. Exclusion criteria will be any
      infants with evidence of pre-existing skin condition, breakdown, rashes, or problems with
      skin integrity. Infants with a known neurological condition (hydrocephalus, Dandy Walker
      malformation, craniosynostosis, AV malformation) will be excluded as well. Also, secondary to
      the nature of the device and the surface area it takes up, infants on CPAP will be excluded
      as well.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary Care Clinic We will not specifically exclude or include women or minorities from
        the research. We expect that the enrollment will include similar numbers of males and
        females. We anticipate that the racial mix of subjects will be broadly typical of their
        representation in the North Central Florida area. However, since minorities are seen
        disproportionately in the NICU we may find more minority representation in our pilot group.
        We have estimated that of our 20 subjects(2 less than the estimated enrollment due to
        attrition rate of 10%), 40% (8)will be Hispanic or Latino and 60% non-Hispanic, from which
        40% (8) will be Black or African American, 20% (4) will be Asian and 40% (8) will be
        classified as white.
      
Keywords: EEG; Brain; Infants; Preterm; Hemorrhage; Bleeding