Clinical trialNCT05030012TerminatedInterventional

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

SponsorVapotherm, Inc.Enrollment15Bronchopulmonary DysplasiaInfant, PrematureNeonatal Respiratory DistressOxygen Saturation

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Billie L Short, MD
Children's National Research Institute
Principal Investigator
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Bradley A Yoder, MD
University of Utah Hospital
Principal Investigator
clinicaltrials.gov ↗
Khodayar Rais-Bahrami, MD
Children's National Research Institute
Principal Investigator
clinicaltrials.gov ↗
Robert DiBlasi, RRT-NPS
Seattle Children's Hospital
Principal Investigator
clinicaltrials.gov ↗
Robert J DiGeronimo, MD
Seattle Children's Hospital
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S National Hospital & Research Institute
Washington D.C., District of Columbia, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Seattle Children'S Hospital
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Sept 2021
Primary completion: 19 Oct 2023
Completion: 19 Oct 2023
Last update posted: 26 Jun 2024
Registered enrollment: 15
Registry id: NCT05030012

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.