Intraventricular Hemorrhage of PrematurityIVHNCT03543046
Tortle Midliner and Intraventricular Hemorrhage
A study testing Tortle Midliner in people with Intraventricular Hemorrhage of Prematurity, run by Orlando Health, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 31 weeks
- Conditions the study is for
- Intraventricular Hemorrhage of Prematurity
- What is being tested?
- Tortle Midliner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2018to 9 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age less than or equal to 30 6/7 weeks at birth
- Less than 3 hours from birth
- Informed consent obtained from parent or legal guardian prior to reaching time point for randomization
Who cannot join
- Presence of genetic/chromosomal abnormality, congenital hydrocephalus, congenital neuromuscular disorder, or other diagnosis determined to impact survival or generalizability of results
- Unable to participate for any reason based on the decision of the principal investigator.
- Infants born outside Winnie Palmer Hospital for Women and Babies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Early Use of the Tortle Midliner and Intraventricular Hemorrhage (IVH) Outcomes in Premature Babies: A Randomized Controlled Trial
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).
Read the 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.
- Being tested
- Tortle Midliner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tortle MidlinerDevice
The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life.
| Study group | Role | What they receive |
|---|---|---|
| Tortle Midliner | Experimental | 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. Receives: Device: Tortle Midliner |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: IVH incidence and/or severity within the first week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start24 Aug 2018
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraventricular Hemorrhage of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrienne C Alexander, RRT MHA DPT, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543046
- Sponsor's protocol ID
- IRB# 17.093.08
- Acronym
- IVH
- Status last verified
- May 2022
- First submitted
- 2 May 2018
- Last updated
- 2 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study data will be shared by publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Early Use of the Tortle Midliner and Intraventricular Hemorrhage (IVH) Outcomes in Premature Babies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03543046
- Acronym / sponsor ID
- IVH / IRB# 17.093.08
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Posted 2 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tortle Midliner | Experimental | Device: Tortle MidlinerThe 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- Up to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age less than or equal to 30 6/7 weeks at birth
- Less than 3 hours from birth
- Informed consent obtained from parent or legal guardian prior to reaching time point for randomization
Key exclusion criteria (3 listed)
- Presence of genetic/chromosomal abnormality, congenital hydrocephalus, congenital neuromuscular disorder, or other diagnosis determined to impact survival or generalizability of results
- Unable to participate for any reason based on the decision of the principal investigator.
- Infants born outside Winnie Palmer Hospital for Women and Babies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tortle MidlinerThe Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life. | Device | Tortle Midliner |
Primary outcome
Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Study data will be shared by publication
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Intelligent Physiological Monitoring to Predict Preterm Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne C Alexander, RRT MHA DPT principal investigator
Orlando Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tortle Midliner in people with Intraventricular Hemorrhage of Prematurity, run by Orlando Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants (time frame: IVH incidence and/or severity within the first week of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.