Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia

Hypoxia Clinical Trial

— HHFNC  

Official title:

Comparison of Heated Humidified High-flow Nasal Cannula (HHFNC) Versus Standard Nasal Cannula Oxygen Delivery on Respiratory Distress and Length of Stay in Infants With Bronchiolitis and Hypoxia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01662544
• Other study ID #: 1103-041
• Status: Active, not recruiting
• Phase: N/A
• First received: August 8, 2012
• Last updated: July 18, 2017
• Start date: August 2012
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: December 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Months

Eligibility

Inclusion Criteria:

1. Are previously healthy infants ages 3 months to 18 months of age

2. Have O2 saturations of < 92% on room air while awake

3. Have a clinical diagnosis of bronchiolitis

4. Have a CSS score showing moderate distress >4

5. Have a planned admission to the hospital for either inpatient or observation status

6. Have parental consent to enroll in study

Exclusion Criteria:

1. Have significant apnea or bradycardia events reported by parent or witnessed in Emergency Department

2. Have prior airway disease diagnosis other than URI within the previous two months

3. Were previously intubated; previously having had airway bronchoscopy or surgery

4. They are ex-preemies, i.e. had an estimated gestational age of <37 weeks at time of birth

5. Have a diagnosis of lobar consolidation or round pneumonia by Chest x-ray

6. Have pleural disease by chest x-ray

7. Have history of cardiac disease, renal disease, hematologic disease such as sickle cell disease or leukemia, congenital hemoglobinopathies or Congenital Adrenal Hyperplasia

8. Have undergone prior radiation or chemotherapy

9. Have functional or anatomical bowel obstruction as demonstrated by persistent vomiting or tensely distended abdomen

10. Have history of Choanal atresia or cleft palate

11. Have history of neuromuscular disorder, e.g., Spinal muscular atrophy, muscular dystrophies, cerebral palsy or hypotonia

12. Have impending respiratory failure as demonstrated by blood gas with pCO2 of greater than 60 or apnea spells lasting greater than 30 seconds

Related Conditions & MeSH terms

• Anoxia
• Bronchiolitis
• Hypoxia

Intervention

Procedure:
• Oxygen delivery

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxygen needs		Study specific
Primary	CSS Scores		Study specific
Secondary	PEWS Score		Study specific