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Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia (HHFNC Trial)

N/A
Waitlist Available
Led By Donna Milner, MD
Research Sponsored by Children's Hospitals and Clinics of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and children. Multiple supportive therapies have been tried in infants with bronchiolitis including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date supportive therapy with oxygen is the only proven therapy to decrease respiratory distress in infants with bronchiolitis, with hypertonic saline showing a borderline statistically significant improvement. This prospective, randomized study will compare CSS and PEWS scores on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen via Humidified High-Flow Nasal Cannula (HHFNC). The results will help determine if infants with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have improved Clinical Severity Score (CSS) and Pediatric Early Warning System (PEWS) scores and ultimately decreased lengths of admissions when compared to patients treated with nasal cannula oxygen therapy with/without bronchodilator therapy. Hypothesis Heated Humidified High-flow Nasal Cannula Delivery of Oxygen decreases respiratory distress as measured by pediatric CSS and PEWS when compared with routine nasal cannula oxygen delivery in infants with bronchiolitis.

Eligible Conditions
  • Bronchiolitis
  • Hypoxic Ventilatory Response
  • Hypoxia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HHFNCExperimental Treatment1 Intervention
Heated High Flow arm
Group II: Standard Nasal CannulaActive Control1 Intervention
Standard treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxygen delivery
2023
N/A
~320

Find a Location

Who is running the clinical trial?

Children's Hospitals and Clinics of MinnesotaLead Sponsor
65 Previous Clinical Trials
5,022,183 Total Patients Enrolled
Donna Milner, MDPrincipal InvestigatorChildren's Hospitals and Clinics of Minnesota
~4 spots leftby Dec 2025