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Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants (MODERATION Neo)

Primary Purpose

Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated Control
Manual Control
Sponsored by
Vapotherm, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature focused on measuring High Velocity Nasal Insufflation (HVNI), Preterm Infants, Noninvasive Ventilatory Support, Automatic Oxygen Titration, Closed Loop Oxygen Control, High Flow Nasal Cannula

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm infants being treated with high velocity nasal insufflation therapy
  • 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 12 manual FiO2 adjustments in the 24hr period prior to trial enrollment.
  • Parents willing/able to complete informed consent.

Exclusion Criteria:

  • Current patient weight of <1000g or >2500g 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

Sites / Locations

  • Children's National Hospital & Research Institute
  • University of Utah Hospital
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Automated Control (OAM)

Manual Control (Manual)

Arm Description

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.

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%.

Outcomes

Primary Outcome Measures

Primary Safety Objective - Proportion 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.
Primary Performance Objective - Proportion 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.

Secondary Outcome Measures

Secondary Performance Objective 1 - Proportion of Time Within SpO2 Target Range (Weight Groups)
Percentage of time spent within target oxygen saturation range across two weight groups (1000g-2500g, 2501g-3500g), measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Secondary Performance Objective 2 - Proportion of Time Within SpO2 Target Range (Skin Pigmentation)
Percentage of time spent within target oxygen saturation range across two skin pigmentation groups (light, dark), measured by pulse oximetry (SpO2). A higher value indicates a better outcome.

Full Information

First Posted
August 25, 2021
Last Updated
October 19, 2023
Sponsor
Vapotherm, Inc.
Collaborators
Children's National Research Institute, Seattle Children's Hospital, University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05030012
Brief Title
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Acronym
MODERATION Neo
Official Title
Maintaining Optimal Delivery Using Automatic Titration of Oxygen in Preterm Infants Receiving High Velocity Nasal Insufflation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
No path to obtain FDA approval for the legacy Precision Flow OAM.
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
October 19, 2023 (Actual)
Study Completion Date
October 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vapotherm, Inc.
Collaborators
Children's National Research Institute, Seattle Children's Hospital, University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Detailed Description: Supplemental oxygen is commonly administered to babies in neonatal intensive care units. The goal of oxygen therapy is to maintain normal oxygenation while minimizing hypoxemia and hypoxemia. Preterm infants are particularly vulnerable to oxygen toxicity and oxidative stress leading to retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and periventricular leukomalacia (PVL). It's also well known that preterm infants experience hypoxic events exposing the baby to low oxygen levels. These hypoxic events vary as the infant matures, but exposure to prolonged and frequent episodes of hypoxemia is associated with increased morbidity and mortality. The delivery of oxygen is generally controlled by a clinician, and the control decisions are generally made using a non-invasive measure of blood oxygen saturation called pulse oximetry (SpO2) and is a standard of care in the neonatal intensive care unit. The most frequent item adjusted by clinicians to maintain SpO2 within specific target ranges is the fraction of the inspired oxygen (FiO2). In a recent study by Reynolds, et al., caregiver manual control of oxygen delivered to NICU babies receiving high velocity therapy resulted in only 49% of the total 24-hour study period with the babies within the target SpO2 range (90-95%). by the caregiver based on the monitored oxygen saturation. Similar to the Reynolds findings, Hagadorn et al., conducted a study in 14 centers and showed that preterm infants under 28 weeks' gestation receiving oxygen spent on average only 48% of the time with SpO2 within the prescribed target range, about 36% of the time above and 16% of the time with SpO2 below the target range. Preterm infants have frequent fluctuations in SpO2 due to their cardio-respiratory instability requiring frequent adjustments of FiO2 . Consequently, these particularly vulnerable infants spend significant time with SpO2 outside the optimal target range and are often exposed to extremes of hypoxemia and hyperoxaemia. The automatic oxygen control system continuously monitors the oxygen saturation and adjusts the oxygen delivery to maintain oxygen saturation within the target range. The efficacy of this mode of oxygen control was demonstrated by Reynolds, et al. in 2018 from two centers in the United Kingdom. Automated control of FiO2 can significantly improve compliance of oxygen saturation targeting and may significantly reduces exposure to hypoxemia as well as hyperoxaemia. The high velocity nasal insufflation therapy is a common mode of non-invasive respiratory support in preterm infants. Unlike prior studies, this study will include a set of hypothesis-driven safety endpoints (proportion of time above or below target range), stratification by body mass at enrolment, and skin pigmentation phenotype. The objective of this randomized control trial is to evaluate the efficacy of the controller (Vapotherm Oxygen Assist Module [OAM]) in maintaining the SpO2 within target range for premature infants receiving high velocity therapy and presenting with a labile FiO2 requirement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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).
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automated Control (OAM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual Control (Manual)
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Device
Intervention Name(s)
Automated Control
Other Intervention Name(s)
Oxygen Assist Module (OAM), Vapotherm OAM + Vapotherm Precision Flow
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Manual Control
Other Intervention Name(s)
Vapotherm Precision Flow, Treatment as Usual (TAU), Standard of Care (SOC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Objective - Proportion of Time Outside of SpO2 Target Range
Description
Percentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome.
Time Frame
Through study completion, two consecutive 24-hour periods
Title
Primary Performance Objective - Proportion of Time Within SpO2 Target Range
Description
Percentage of time spent within target oxygen saturation range, measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Time Frame
Through study completion, two consecutive 24-hour periods
Secondary Outcome Measure Information:
Title
Secondary Performance Objective 1 - Proportion of Time Within SpO2 Target Range (Weight Groups)
Description
Percentage of time spent within target oxygen saturation range across two weight groups (1000g-2500g, 2501g-3500g), measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Time Frame
Through study completion, two consecutive 24-hour periods
Title
Secondary Performance Objective 2 - Proportion of Time Within SpO2 Target Range (Skin Pigmentation)
Description
Percentage of time spent within target oxygen saturation range across two skin pigmentation groups (light, dark), measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Time Frame
Through study completion, two consecutive 24-hour periods

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Billie L Short, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khodayar Rais-Bahrami, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert J DiGeronimo, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert DiBlasi, RRT-NPS
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley A Yoder, MD
Organizational Affiliation
University of Utah Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Hospital & Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30464005
Citation
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.
Results Reference
background
PubMed Identifier
17015549
Citation
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.
Results Reference
background

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

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