High Flow Nasal Cannula in Preterm Infants (HIFLO)

December 27, 2016 updated by: Jean-charles PICAUD, MD, PhD, Hôpital de la Croix-Rousse

Effect of High-flow Nasal Cannula Therapy on Exposure to Nasal Continuous Positive Airway Pressure in Very Preterm Infants

The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nasal continuous positive airway pressure (nCPAP) is widely used in preterm infants as it is efficient, but it creates an unfavorable environment for preterm infants. Indeed is a primary source of continuous noise in neonatal units and causes discomfort, pain, skin lesions. High flow nasal cannula (HFNC) introduced more recently in neonatal care supplies high allowing for carbon dioxide nasopharyngeal wash-out, reduction of work of breathing and is well tolerated. HFNC could help to improve the environment of preterm infants by reducing deleterious stimuli (noise, pain, discomfort) and by facilitating the contact between parents and babies. Efficacy of HFNC seems to be similar to other non-invasive respiratory supports for preventing treatment failure, death and bronchopulmonary dysplasia. The benefits of HFNC implementation was only slightly analyzed in extremely preterm infants. the place of HFNC is becoming increasingly important in neonatology and could help to improve the quality of care. Few HFNC devices are available but their cost of use has not been evaluated in Europe.

HIFLO study aimed to assess the impact of HFNC therapy introduction, on exposure to nCPAP and on the duration of oxygen therapy and hospital stay in preterm infants and in a subgroup of extremely preterm infants. The investigators also aim to evaluate the cost of use of nCPAP and HFNC using two different devices.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hôpital de La Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All preterm infants born during year 2011 and year 2014, before 32 weeks of gestational age (GA) or with a birth weight below 1500 g, hospitalized within the first 48 hours of life in the tertiary care unit at Croix-Rousse Hospital, Lyon, France and discharged home from the unit.

Description

Inclusion Criteria:

  • Infants born before 32 weeks of gestational age
  • Birth weight below 1500 g
  • Infants hospitalized within the first 48 hours of life
  • Infants discharged home from our unit

Exclusion Criteria:

  • Infants transferred to another unit
  • Infants with a severe malformation
  • Infants requiring surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Period 1
year 2011 nCPAP
Period 2
year 2014 nCPAP and high flow nasal cannula
Other: High flow nasal cannula
High flow nasal cannula added to the therapeutic arsenal in neonatal care
Other Names:
  • HFNC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of exposure to nCPAP, expressed in days in the population of very preterm infants.
Time Frame: 2 years
The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of oxygen therapy (expressed in days) in the population of very preterm infants.
Time Frame: 2 years
The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.
2 years
Duration of hospital stay (expressed in days) in the population of very preterm infants.
Time Frame: 2 years
The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.
2 years
Duration of exposure to nCPAP (expressed in days) in extremely preterm infants.
Time Frame: 2 years
It will be the same evaluation than in whole population, but in extremely preterm infants borm before 29 weeks gestational age.
2 years
The cost of use (expressed in Euros) of nCPAP and HFNC using two different devices.
Time Frame: 2 years
Cost analysis will be carried out for the three devices: Infant Flow SiPAP, OptiFlow and Precision Flow, including all consumables. To evaluate the costs these devices will be used as recommended by the manufacturers.The calculated costs will be based on an example of three devices in constant use on a 7-day cycle change of the circuits for the Opti-Flow device, and 30-day cycle change for Precision Flow device. Actual costs will be expressed as price per patient per week.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital de la Croix-Rousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIFLO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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