Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants

NCT05030012 | Terminated Results DMC FDA Device

• 1 other identifier: RP-NIOA2019001Reg
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability. Oxygen control in preterm infants requires frequent adjustments in the amount of oxygen delivered to the baby. This is generally performed manually by a clinician attending the baby, and generally directed to maintaining a specific range of blood oxygen saturation. The manual control often results in only half of the time in the specified range, with the baby experiencing high and low blood oxygen saturations. The technology being studied is designed to assist the clinician in maintaining blood oxygen saturation within target range by measuring oxygen saturation and automatically adjusting the amount of oxygen delivered for babies receiving high velocity nasal insufflation (an advanced form of high flow oxygen therapy). The proposed study will evaluate the efficacy and safety of the automatic control of oxygen by the new technology, as compared to manual control, among babies receiving high velocity therapy in a neonatal intensive care unit.

Conditions

Infant, Premature; Neonatal Respiratory Distress; Oxygen Saturation; Bronchopulmonary Dysplasia

Keywords

High Velocity Nasal Insufflation (HVNI); Preterm Infants; Noninvasive Ventilatory Support; Automatic Oxygen Titration; Closed Loop Oxygen Control; High Flow Nasal Cannula

Outcome Measures

Primary Outcomes (2)

• Primary Safety Objective - Percentage of Time Outside of SpO2 Target Range

  Percentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome.

  Through study completion, two consecutive 24-hour periods

• Primary Performance Objective - Percentage of Time Within SpO2 Target Range

  Percentage of time spent within target oxygen saturation range, measured by pulse oximetry (SpO2). A higher value indicates a better outcome.

  Through study completion, two consecutive 24-hour periods

Secondary Outcomes (2)

• Performance Endpoint, Percentage of Time IN Range (SpO2 in 90-95% With FiO2 Special at .21) Across the Two Weight Groups.

  Through study completion, two consecutive 24-hour periods

• Secondary Performance Objective 2 - Percentage of Time Within SpO2 Target Range (Skin Pigmentation)

  Through study completion, two consecutive 24-hour periods

Study Arms (2)

Automated Control (OAM)

EXPERIMENTAL

In this arm, FiO2 levels delivered via high-velocity nasal insufflation therapy (Vapotherm Precision Flow) will be adjusted by the Oxygen Assist Module (OAM) to keep the infants pulse oxygen saturation within a target range (90-95%). Clinical staff will have the ability to override FiO2 levels when required, and instructed to do so.

Device: Automated Control

Manual Control (Manual)

ACTIVE COMPARATOR

In this arm, FiO2 levels delivered via high-velocity nasal insufflation therapy (Vapotherm Precision Flow) will be manually adjusted by clinical staff to keep infants' oxygen saturation between 90-95%.

Device: Manual Control

Interventions

Automated Control DEVICE

The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.

Also known as: Oxygen Assist Module (OAM), Vapotherm OAM + Vapotherm Precision Flow

Automated Control (OAM)

Manual Control DEVICE

The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.

Also known as: Vapotherm Precision Flow, Treatment as Usual (TAU), Standard of Care (SOC)

Manual Control (Manual)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants delivered at a gestational age of less than or equal to 35 6/7 weeks (Preterm) being treated with high velocity nasal insufflation therapy for the management of respiratory distress syndrome
• Patients that clinically require SpO2 maintenance within the target range of 90-95%
• A need for supplemental oxygen as demonstrated by a required FiO2 \> 0.25 at enrollment
• Requiring a flow rate of greater than 2 L•min-1 such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HVNI).
• A minimum of 6 manual FiO2 adjustments in the 24hr period prior to trial enrollment.
• Willing/Able to complete informed consent.

You may not qualify if:

• Current patient weight of \<1000g or \>3500g at time of study
• Major congenital abnormalities
• Hemodynamic instability, defined as being outside of a normotensive range based on an infant's individual characteristics by clinician
• Persistent unresolved apnea defined as: requiring 6 stimulations or more per 6 hours
• Seizures
• Ongoing sepsis
• Meningitis
• Clinician's concern regarding stability of the infant

Sponsors & Collaborators

• Vapotherm, Inc.: lead
• Children's National Research Institute: collaborator
• Seattle Children's Hospital: collaborator
• University of Utah: collaborator

Study Sites (3)

Children's National Hospital & Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.

  PMID: 30464005 BACKGROUND

• Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413.

  PMID: 17015549 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pulmonary Atelectasis; Bronchopulmonary Dysplasia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Katherine Gerich
• Organization: Vapotherm

kgerich@vtherm.com

5854696753

Study Officials

• Billie L Short, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• Khodayar Rais-Bahrami, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• Robert J DiGeronimo, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Robert DiBlasi, RRT-NPS

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Bradley A Yoder, MD

  University of Utah Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is unblinded, as there is a distinct difference in modality control between automated and manual modes. Clinical staff are instructed to perform FiO2 adjustments as required, regardless of the study arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be a prospective, multi-center, randomized, crossover trial evaluating automated oxygen titration versus manual titration in maintaining oxygen saturation levels in preterm infants requiring noninvasive ventilatory support via high velocity nasal insufflation (HVNI).

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 1, 2021
• Study Start: September 2, 2021
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)