Tortle Midliner and Intraventricular Hemorrhage

NCT03543046 | Terminated Results FDA Device

• 1 other identifier: IRB# 17.093.08
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Intraventricular Hemorrhage of Prematurity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Interventions

Tortle Midliner DEVICE

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

Tortle Midliner

Eligibility Criteria

• Age: Up to 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orlando Health, Inc.: lead

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

Limitations and Caveats

The investigator left the institution prematurely, The final study number of participants in both arms was small. More studies should be completed and evaluated.

Results Point of Contact

• Title: Corporate Director of Compliance and Regulations
• Organization: Orlando Health

Tara.Roberts@orlandohealth.com

3218413687

Study Officials

• Adrienne C Alexander, RRT MHA DPT

  Orlando Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 1, 2018
• Study Start: August 24, 2018
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: June 2, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)