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

NATerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 2, 2021

Primary Completion Date

October 19, 2023

Study Completion Date

October 19, 2023

Conditions
Infant, PrematureNeonatal Respiratory DistressOxygen SaturationBronchopulmonary Dysplasia
Interventions
DEVICE

Automated Control

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.

DEVICE

Manual Control

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.

Trial Locations (3)

20010

Children's National Hospital & Research Institute, Washington D.C.

84132

University of Utah Hospital, Salt Lake City

98195

Seattle Children's Hospital, Seattle

All Listed Sponsors
collaborator

Children's National Research Institute

OTHER

collaborator

Seattle Children's Hospital

OTHER

collaborator

University of Utah

OTHER

lead

Vapotherm, Inc.

INDUSTRY