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Acute Viral BronchiolitisPhase 3NCT01873144

High Flow Therapy vs Hypertonic Saline in Bronchiolitis

A Phase 3 study testing Epinephrine 1/1000, HSS 3% and HHHFNC in people with Acute Viral Bronchiolitis, run by Ministry of Health, Spain at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission… Read more about this study

Who is it for?
Ages Up to 6 months
Conditions the study is for
Acute Viral Bronchiolitis
What is being tested?
Epinephrine 1/1000, HSS 3% and HHHFNC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesSpain
Study dates
Oct 2010to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 6 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 6 months or less
  • Moderate (Respiratory Distress Assessment Instrument score of 4 or greater) viral bronchiolitis (as defined by McConnockie)
  • Meeting Admission criteria

Who cannot join

  • History of prematurity
  • Chronic lung disease
  • Cystic fibrosis
  • Congenital heart disease
  • Neuromuscular disease
  • Airway anomalies
  • Immunodeficiency
  • Those requiring immediate intubation and ventilation.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid, 28911

Other trials in Spain

About this study

Official title: High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial

The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).

Being tested
Epinephrine 1/1000, HSS 3%, HHHFNC, NS (0.9%)
Keywords
Bronchiolitis, Hypertonic saline solution, High-flow oxygen therapy, Respiratory distress, Comfort
Medical subject headings
Bronchiolitis, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epinephrine 1/1000Drug

    Also called Adrenaline 1/1000, Adrenalin 1/1000

    Nebulization of 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 every 4h for three times and afterwards at physician in charge criteria

  • HSS 3%Drug

    Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria

  • HHHFNCDevice

    Precision Flow (Vapotherm Inc. Stevensville, Maryland, US ) and RT329 (Fisher and Paykel Healthcare, Auckland, New Zealand) were the dispositive used depending on the availability. Fisher and Paykel nasal cannula was used in both devices, depending on age

  • NS (0.9%)Drug

    Also called Normal saline solution 0.9%, Physiologic saline solution

    Nebulization of 2 mL of NS (0.9%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria

Study groups in NCT01873144
Study groupRoleWhat they receive
HSS (3%) + epinephrineActive comparatorNebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of HSS(3%) every 4h for three times and afterwards at physician in charge criteria.
Receives: Drug: Epinephrine 1/1000; Drug: HSS 3%
HHHFNC+epinephrine+Normal Saline(0.9%)ExperimentalFlow depending on weight (Tidal volume x respiratory rate x 9) and nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of Normal Saline (NS) (0.9%) every 4h and afterwards at physician in charge criteria.
Receives: Drug: Epinephrine 1/1000; Device: HHHFNC; Drug: NS (0.9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered

    RACS is calculated by combining 2 values: the difference between the Respiratory Distress Assessment Instrument (RDAI) score before and after treatment, plus a value of +1 for each 10% improvement (decrease) in the posttreatment respiratory rate (RR) or a value of -1 for each 10% worsening (increase) in RR.

    Measured: Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h)

Secondary outcomes (1)

  1. Difference in mean comfort score along the monitoring period between groups

    A scale was used for comfort evaluation . It is based on 4 items: rest, feeding, alertness and facial expression (facial pictures).Minimum 4-Maximum 16

    Measured: Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2013 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01873144
Sponsor's protocol ID
EC11-437
Status last verified
Jun 2013
First submitted
29 May 2013
Last updated
7 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • Bueno Campana M, Olivares Ortiz J, Notario Munoz C, Ruperez Lucas M, Fernandez Rincon A, Patino Hernandez O, Calvo Rey C. High flow therapy versus hypertonic saline in bronchiolitis: randomised controlled trial. Arch Dis Child. 2014 Jun;99(6):511-5. doi: 10.1136/archdischild-2013-305443. Epub 2014 Feb 12.

    PubMed 24521787

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epinephrine 1/1000, HSS 3% and HHHFNC in people with Acute Viral Bronchiolitis, run by Ministry of Health, Spain at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (time frame: Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01873144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.

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