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NCT Number: NCT03095495

High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Syncytial Virus (RSV) Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alsadd Pediatric Emergency Center

Doha, Qatar

About this study

Setting:

The study will be conducted between June 2017 and June 2020 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis with positive RSV test will be eligible for the study.

Procedure:

Eligible patients will be enrolled after obtaining written consent. For patients who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized in one of the study arms. Adverse effects in each group will be carefully monitored and documented.

Study Intervention:

Patients will be randomized into two treatment arms

Group 1: Early HHHFNC Group Patients in this group will be treated by using heated humidified high flow oxygen /air via nasal cannula; investigators will keep the patient on HHHFNC until he/she becomes clinically ready for discharge.

Group 2: Standard Therapy and Rescue HHHFNC Group:

patients in this group will be treated by usual therapy,investigators will use low flow nasal cannula oxygen therapy only if oxygenation needed to maintain Oxygen saturation (SpO2) ≥ 92% , if the patient deteriorate and require ICU, rescue HHHFNC will be started before admission to the ICU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously healthy infants with age 0-3 months and gestational age ≥30 weeks admitted to the short stay unit with RSV positive bronchiolitis and clinical severity score ≥4 on Wang clinical severity scale.

Exclusion criteria

  • Gestational age less than 30 weeks.
  • Previous history of wheezing.
  • Use of steroid within 48 hours of presentation.
  • History of chronic lung disease.
  • Infants admitted directly to ICU.
  • Prior invasive or non-invasive ventilatory support.
  • Tracheostomy.
  • Nasogastric tubes in situ on admission.
  • Upper airway abnormality (like choanal atresia and midfacial anomalies).
  • Immunodeficient children.
  • History of cardiac disease, renal disease or liver disease.
  • History of neuromuscular disorder.

Treatment and study plan

Heated Humidified High Flow Nasal Cannula

Device

HHHFNC therapy is a simple to use system that delivers warm and moist air/oxygen mixture at high flow rates that generate positive airway pressure

Standard Therapy (Low Flow Nasal Cannula)

Device

will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU

Primary outcomes

  1. The rate of Pediatric Intensive Care Unit (PICU) admissions

    Time frame: Through study completion, an average of 3 year

    The rate of Pediatric Intensive Care Unit admissions

Secondary outcomes

  1. Mean length of stay (LOS)

    Time frame: Through study completion, an average of 3 year

    Geometric mean length of stay in the short stay unit

  2. Bronchiolitis Severity Score (BSS)

    Time frame: Up to 72 hours

    Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours

  3. Percentage of revisit, infirmary short-stay and admission to the hospital or PICU

    Time frame: 2 weeks after discharge

    Percentage of revisit, infirmary short-stay and admission to the hospital or PICU for the same illness on follow up for two weeks post discharge

  4. Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)

    Time frame: Up to 72 hours

    Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours

  5. Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED

    Time frame: 1 hour after starting of rescue HHHFNC

    Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Collaborators

  • Sidra Medicine

Registry information

Official study title

Heated Humidified High Flow Nasal Cannula (HHHFNC) For Acute Moderate to Severe RSV-Bronchiolitis in Infants Younger Than 3 Months Old: Early Versus Rescue

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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