Detection and Quantification of Neonatal Intraventricular Hemorrhage

NCT01899651 | Completed

• 2 other identifiers: 77598-011R43NS077598-01A1
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraventricular Brain Hemorrhage

Keywords

EEG; Brain; Infants; Preterm; Hemorrhage; Bleeding

Outcome Measures

Primary Outcomes (1)

• Safety of Dense Array EEG monitoring systems in preterm infant population.

  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.

  Few days after Dense Array EEG session.

Study Arms (1)

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.

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Preterm infants 30-34 weeks gestation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Electrical Geodesics, Inc.: lead
• University of Florida: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

UF Health Shands Hospital NICU

Gainsville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Premature Birth; Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Weiss, M.D.

  University of Florida College of Medicine Department of Pediatric, Division of Neonatalgy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 15, 2013
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2014-11

Locations

US (1)