Trial Outcomes & Findings for Tortle Midliner and Intraventricular Hemorrhage (NCT NCT03543046)

Last Updated: 2022-06-02

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

IVH incidence and/or severity within the first week of life

Results posted on

2022-06-02

Participant Flow

Subjects were recruited in the NICU that met inclusion criteria

27 subjects were randomized. 13 enrolled into the control arm and 14 in the treatment arm. 5 subjects were withdrawn after randomization ( 2 in the control arm and 3 in the treatment arm). 22 Completed study

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	14	13
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	1	1
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

Tortle Midliner and Intraventricular Hemorrhage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tortle Midliner n=14 Participants 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.	Control Group n=13 Participants 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.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=39 Participants	13 Participants n=41 Participants	27 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Sex: Female, Male Female	6 Participants n=39 Participants	4 Participants n=41 Participants	10 Participants n=35 Participants
Sex: Female, Male Male	8 Participants n=39 Participants	9 Participants n=41 Participants	17 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	5 Participants n=39 Participants	5 Participants n=41 Participants	10 Participants n=35 Participants
Race (NIH/OMB) White	3 Participants n=39 Participants	6 Participants n=41 Participants	9 Participants n=35 Participants
Race (NIH/OMB) More than one race	5 Participants n=39 Participants	2 Participants n=41 Participants	7 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants

PRIMARY outcome

Timeframe: IVH incidence and/or severity within the first week of life

Outcome measures

Outcome measures
Measure	Tortle Midliner n=11 Participants 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.	Control Group n=11 Participants 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.
Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants Incidence of IVH	3 Participants	3 Participants
Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants Incidence of no IVH	8 Participants	8 Participants

Adverse Events

Tortle Midliner

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Tortle Midliner n=14 participants at risk 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.	Control Group n=13 participants at risk 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.
Vascular disorders Hypotensive shock unresponsive to aggressive vasopressor therapy	0.00% 0/14 • Adverse events were followed from enrollment to discharge. Both groups meet criteria for a head ultrasound at 6-8 days of life. The results of the last head ultrasound and/or magnetic resonance imaging (MRI) of the brain before discharge will be collected. The duration from birth to discharge depends on the subject's medical needs. A duration of "Hospital Stay in Days" was collected as a variable. From enrollment to hospital discharge, the average timeframe was 72 days. The device, Tortle Midliner, solely impacts the skin contact areas. Only adverse events related to skin breakdown requiring wound care consultation with wound treatment will be reported as an adverse event. The principal investigator will evaluate adverse events related to skin integrity. Any death will be reported as a serious adverse event according to Orlando Health IRB policy.	7.7% 1/13 • Number of events 1 • Adverse events were followed from enrollment to discharge. Both groups meet criteria for a head ultrasound at 6-8 days of life. The results of the last head ultrasound and/or magnetic resonance imaging (MRI) of the brain before discharge will be collected. The duration from birth to discharge depends on the subject's medical needs. A duration of "Hospital Stay in Days" was collected as a variable. From enrollment to hospital discharge, the average timeframe was 72 days. The device, Tortle Midliner, solely impacts the skin contact areas. Only adverse events related to skin breakdown requiring wound care consultation with wound treatment will be reported as an adverse event. The principal investigator will evaluate adverse events related to skin integrity. Any death will be reported as a serious adverse event according to Orlando Health IRB policy.
Respiratory, thoracic and mediastinal disorders Respiratory Distress Syndrome	7.1% 1/14 • Number of events 1 • Adverse events were followed from enrollment to discharge. Both groups meet criteria for a head ultrasound at 6-8 days of life. The results of the last head ultrasound and/or magnetic resonance imaging (MRI) of the brain before discharge will be collected. The duration from birth to discharge depends on the subject's medical needs. A duration of "Hospital Stay in Days" was collected as a variable. From enrollment to hospital discharge, the average timeframe was 72 days. The device, Tortle Midliner, solely impacts the skin contact areas. Only adverse events related to skin breakdown requiring wound care consultation with wound treatment will be reported as an adverse event. The principal investigator will evaluate adverse events related to skin integrity. Any death will be reported as a serious adverse event according to Orlando Health IRB policy.	7.7% 1/13 • Number of events 1 • Adverse events were followed from enrollment to discharge. Both groups meet criteria for a head ultrasound at 6-8 days of life. The results of the last head ultrasound and/or magnetic resonance imaging (MRI) of the brain before discharge will be collected. The duration from birth to discharge depends on the subject's medical needs. A duration of "Hospital Stay in Days" was collected as a variable. From enrollment to hospital discharge, the average timeframe was 72 days. The device, Tortle Midliner, solely impacts the skin contact areas. Only adverse events related to skin breakdown requiring wound care consultation with wound treatment will be reported as an adverse event. The principal investigator will evaluate adverse events related to skin integrity. Any death will be reported as a serious adverse event according to Orlando Health IRB policy.

Other adverse events

Adverse event data not reported

Additional Information

Corporate Director of Compliance and Regulations

Orlando Health

Phone: 3218413687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place