Intraventricular Hemorrhage of Prematurity
Conditions
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.
Interventions
DEVICETortle 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.
Sponsors
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 31 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants | IVH incidence and/or severity within the first week of life | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited in the NICU that met inclusion criteria
Pre-assignment details
27 subjects were randomized. 13 enrolled into the control arm and 14 in the treatment arm. 5 subjects were withdrawn after randomization ( 2 in the control arm and 3 in the treatment arm). 22 Completed study
Participants by arm
| Arm | Count |
|---|---|
| Tortle Midliner The use of the Tortle Midliner will be in addition to the NICU department process guidelines for positioning relevant to the gestational age of the subject. The Tortle Midliner will be applied no later than 3 hours following birth under the supervision of a study investigator. The size/fit and application of the device will be according to the manufacturer's guidelines. The neutral midline head position, supine or slightly side-lying, with a bed elevation between 15° and 30° will be maintained during the first 72 hours of life.
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. | 14 |
| Control Group All clinical care for the control group will be within NICU department process guidelines relevant to the gestational age of the subject and as ordered by physician and/or ARNP providers. The neutral midline head position with the aid of nesting and/or rolls with a bed elevation between 15° and 30° will be maintained throughout position changes during the first 72 hours of life, which is standard practice. Caregivers will document the NICU integrated flowsheet and the Sunrise electronic record with interventions regarding positioning, handling, skin assessment etc. per standard practice requirements. | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Tortle Midliner | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 13 Participants | 27 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 1 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 1 / 14 | 2 / 13 |
Outcome results
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.
Time frame: IVH incidence and/or severity within the first week of life
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tortle Midliner | Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants | Incidence of IVH | 3 Participants |
| Tortle Midliner | Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants | Incidence of no IVH | 8 Participants |
| Control Group | Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants | Incidence of IVH | 3 Participants |
| Control Group | Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants | Incidence of no IVH | 8 Participants |