Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants (MODERATION Neo)
Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation
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
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
Experimental
Active Comparator
Automated Control (OAM)
Manual Control (Manual)
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%.