Tortle Midliner and Intraventricular Hemorrhage
Tortle Midliner and Intraventricular Hemorrhage
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).
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.
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