Clinical trial NCT03543046: Tortle Midliner and Intraventricular Hemorrhage
Official title: An Evaluation of Early Use of the Tortle Midliner and Intraventricular Hemorrhage (IVH) Outcomes in Premature Babies: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intraventricular Hemorrhage of Prematurity
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 27
Sex: ALL
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Gestational age less than or equal to 30 6/7 weeks at birth
2. Less than 3 hours from birth
3. Informed consent obtained from parent or legal guardian prior to reaching time point for randomization

Exclusion Criteria:

1. Presence of genetic/chromosomal abnormality, congenital hydrocephalus, congenital neuromuscular disorder, or other diagnosis determined to impact survival or generalizability of results
2. Unable to participate for any reason based on the decision of the principal investigator.
3. Infants born outside Winnie Palmer Hospital for Women and Babies

Primary outcomes:
measure: Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants
timeFrame: IVH incidence and/or severity within the first week of life
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health
name: Adrienne C Alexander, RRT MHA DPT
role: PRINCIPAL_INVESTIGATOR
References: