NCT03007056

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

3.9 years

First QC Date

November 1, 2016

Last Update Submit

December 27, 2016

Conditions

Prematurity; Extreme

Keywords

high flow nasal cannulanasal continuous positive airway pressurenoninvasive ventilatory supportnewborn developmental carebronchopulmonary dysplasiaweaningpainlength of stay

Outcome Measures

Primary Outcomes (1)

  • Duration of exposure to nCPAP, expressed in days in the population of very preterm infants.

    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 Outcomes (4)

  • Duration of oxygen therapy (expressed in days) in the population of very preterm infants.

    2 years

  • Duration of hospital stay (expressed in days) in the population of very preterm infants.

    2 years

  • Duration of exposure to nCPAP (expressed in days) in extremely preterm infants.

    2 years

  • The cost of use (expressed in Euros) of nCPAP and HFNC using two different devices.

    2 years

Study Arms (2)

Period 1

year 2011 nCPAP

Period 2

year 2014 nCPAP and high flow nasal cannula

Other: High flow nasal cannula

Interventions

High flow nasal cannulaOTHER

High flow nasal cannula added to the therapeutic arsenal in neonatal care

Also known as: HFNC
Period 2

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de la croix rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Premature BirthBronchopulmonary DysplasiaPain

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • jean-charles picaud, MD, PhD

    Hopital de la croix rousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of pediatrics

Study Record Dates

First Submitted

November 1, 2016

First Posted

January 2, 2017

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Study Completion

September 1, 2016

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)