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Detection and Quantification of Neonatal Intraventricular Hemorrhage (DQNIH)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Florida
Information provided by (Responsible Party):
Electrical Geodesics, Inc.
ClinicalTrials.gov Identifier:
NCT01899651
First received: July 11, 2013
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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.


Condition
Intraventricular Brain Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Quantification of Neonatal Intraventricular Hemorrhage

Resource links provided by NLM:


Further study details as provided by Electrical Geodesics, Inc.:

Primary Outcome Measures:
  • Safety of Dense Array EEG monitoring systems in preterm infant population. [ Time Frame: Few days after Dense Array EEG session. ] [ Designated as safety issue: No ]
    There will be a nursing evaluation form for the clinical 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 and 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 per accepted preterm neonatal skin care protocols.


Estimated Enrollment: 22
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants of 30-34 weeks gestation.
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, arteriovenous malformation) will be excluded as well. Also, secondary to the nature of the device and the surface area it takes up, infants on continuous positive airway pressure will be excluded as well.

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.

  Eligibility

Ages Eligible for Study:   30 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

Preterm infants 30-34 weeks gestation.

Exclusion Criteria:

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, arteriovenous malformation) will be excluded as well. Also, secondary to the nature of the device and the surface area it takes up, infants on continuous positive airway pressure will be excluded as well.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899651

Locations
United States, Florida
UF Health Shands Hospital NICU
Gainsville, Florida, United States, 32608
Sponsors and Collaborators
Electrical Geodesics, Inc.
University of Florida
Investigators
Principal Investigator: Michael Weiss, M.D. University of Florida College of Medicine Department of Pediatric, Division of Neonatalgy
  More Information

No publications provided

Responsible Party: Electrical Geodesics, Inc.
ClinicalTrials.gov Identifier: NCT01899651     History of Changes
Other Study ID Numbers: 77598-01, 1R43NS077598-01A1
Study First Received: July 11, 2013
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Electrical Geodesics, Inc.:
EEG
Brain
Infants
Preterm
Hemorrhage
Bleeding

Additional relevant MeSH terms:
Cerebral Hemorrhage
Fetal Diseases
Hemorrhage
Infant, Newborn, Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Pregnancy Complications
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014