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

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Brief Title

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

Official Title

Maintaining Optimal Delivery Using Automatic Titration of Oxygen in Preterm Infants Receiving High Velocity Nasal Insufflation Therapy

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.
    


Study Type

Interventional


Primary Outcome

Primary Safety Objective - Proportion of Time Outside of SpO2 Target Range

Secondary Outcome

 Secondary Performance Objective 1 - Proportion of Time Within SpO2 Target Range (Weight Groups)

Condition

Infant, Premature

Intervention

Automated Control

Study Arms / Comparison Groups

 Automated Control (OAM)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

47

Start Date

August 23, 2021

Completion Date

June 30, 2022

Primary Completion Date

March 31, 2022

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Billie L Short, MD, 2673473305, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05030012

Organization ID

RP-NIOA2019001Reg


Responsible Party

Sponsor

Study Sponsor

Vapotherm, Inc.

Collaborators

 Children's National Research Institute

Study Sponsor

Billie L Short, MD, Principal Investigator, Children's National Research Institute


Verification Date

August 2021