Detection and Quantification of Neonatal Intraventricular Hemorrhage

NCT ID: NCT01899651

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-08-31

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.

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.

Conditions

Intraventricular Brain Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Electrical Geodesics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Weiss, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

UF Health Shands Hospital NICU

Gainsville, Florida, United States

Countries

United States

Other Identifiers

1R43NS077598-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

77598-01

Identifier Type: -

Identifier Source: org_study_id