Detection and Quantification of Neonatal Intraventricular Hemorrhage
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Neurology, Women's Studies |
| Therapuetic Areas: | Neurology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | August 2016 |
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.
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.
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.
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.
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.
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