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Device

Automated Control for Bronchopulmonary Dysplasia (MODERATION Neo Trial)

N/A
Waitlist Available
Led By Khodayar Rais-Bahrami, MD
Research Sponsored by Vapotherm, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, two consecutive 24-hour periods
Awards & highlights

MODERATION Neo Trial Summary

This trial will test a new technology to help control the amount of oxygen given to premature babies, which will hopefully improve their outcomes.

Eligible Conditions
  • Bronchopulmonary Dysplasia
  • Premature Infants
  • Respiratory Distress Syndrome
  • Oxygen Saturation

MODERATION Neo Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, two consecutive 24-hour periods
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, two consecutive 24-hour periods for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Performance Objective - Proportion of Time Within SpO2 Target Range
Primary Safety Objective - Proportion of Time Outside of SpO2 Target Range
Secondary outcome measures
Secondary Performance Objective 1 - Proportion of Time Within SpO2 Target Range (Weight Groups)
Secondary Performance Objective 2 - Proportion of Time Within SpO2 Target Range (Skin Pigmentation)

MODERATION Neo Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Automated Control (OAM)Experimental Treatment1 Intervention
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.
Group II: Manual Control (Manual)Active Control1 Intervention
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%.

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalOTHER
301 Previous Clinical Trials
5,216,962 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
40 Patients Enrolled for Bronchopulmonary Dysplasia
University of UtahOTHER
1,095 Previous Clinical Trials
1,775,570 Total Patients Enrolled
4 Trials studying Bronchopulmonary Dysplasia
101 Patients Enrolled for Bronchopulmonary Dysplasia
Vapotherm, Inc.Lead Sponsor
11 Previous Clinical Trials
457 Total Patients Enrolled

Media Library

New Technology (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05030012 — N/A
Bronchopulmonary Dysplasia Research Study Groups: Automated Control (OAM), Manual Control (Manual)
Bronchopulmonary Dysplasia Clinical Trial 2023: New Technology Highlights & Side Effects. Trial Name: NCT05030012 — N/A
New Technology (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05030012 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
2021. "Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05030012.
~4 spots leftby Apr 2025
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