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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.


Recruitment information / eligibility

Status Terminated
Enrollment 27
Est. completion date January 9, 2020
Est. primary completion date January 9, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 31 Weeks
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Tortle Midliner
The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life.

Locations

Country Name City State
United States Orlando Health Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Orlando Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants Data analysis will include descriptive statistics with means and proportions. Comparative statistics will be used to compare IVH outcomes in the two groups. IVH outcome will be determined by a reduction in the incidence and/or severity of IVH. Any additional information on data points may be described in tables and/or graphs. IVH incidence and/or severity within the first week of life
See also
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Withdrawn NCT03390530 - Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage Phase 3
Terminated NCT01482559 - Management of Hypotension In the Preterm Infant Phase 3
Recruiting NCT06280872 - Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns N/A
Recruiting NCT05617833 - Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage Phase 1