Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03543046 |
| Other study ID # |
IRB# 17.093.08 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 24, 2018 |
| Est. completion date |
January 9, 2020 |
Study information
| Verified date |
May 2022 |
| Source |
Orlando Health, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to determine if early application of the Tortle Midliner for
preterm infants, ≤ 3 hours following birth and with subsequent continuous use through 72 hrs.
of life to ensure maintenance of optimal midline positioning (Tortle group), will impact the
IVH outcome as determined by a reduction in the rate and/or severity of IVH when compared to
infants receiving the standard regimen of care (Control group).
Description:
Intraventricular hemorrhage (IVH) is defined as bleeding into the ventricles of the premature
infant brain-the highest risk for the lowest gestational ages. IVH almost always occurs
between birth and the first 72 hours of life. The four grades of IVH are based on the degree
of bleeding; the greater the severity of the bleed, the more likely to have a poor outcome.
Complications can include hydrocephalus, mental retardation, cerebral palsy and seizures.
Neurologic sequelae can lead to death. Even for low grade bleeds the studies show the
negative effects on cognitive scores and an increased incidence of learning disabilities. In
addition, these same children often suffer from attention deficit disorder and other
behavioral dysfunctions, which require intervention in order for the child to successfully
integrate into school and society.
Since increased risk of IVH can be associated with changes of intracranial pressure, many
medical protocols have established IVH bundles which are designed to help reduce fluctuations
in intracranial pressure while managing the micro-preemie infant during the first few days of
life.
The correlation between IVH and head positioning of the extremely low birth weight infants
has made its way into research literature suggesting that venous obstruction can result from
increased external pressure on the venous system when the micro-preemie infant has their head
positioned to the side rather than maintaining a neutral position.
Therefore, the investigators are aiming to conduct a prospective randomized controlled trial
in order to answer the research question: Does early use of the Tortle Midliner reduce the
incidence and/or level of severity of intraventricular hemorrhage if used in infants born at
≤ 30 6/7 weeks and neutral position is maintained for the first 72 hours of life? The
investigators hypothesize that the use of early consistent neutral positioning compared to
the standard care (nested positioning) practiced in the Neonatal Intensive Care Unit (NICU)
will reduce the risk of intraventricular hemorrhage in preterm infants born at ≤ 30 6/7 weeks
and have a positive effect on the incidence and/or level of severity of intraventricular
hemorrhage in this population.
