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High Flow Nasal Cannula in Preterm Infants (HIFLO)

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ClinicalTrials.gov Identifier: NCT03007056
Recruitment Status : Completed
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Jean-charles PICAUD, MD, PhD, Hôpital de la Croix-Rousse

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.

Condition or disease Intervention/treatment
Prematurity; Extreme Other: High flow nasal cannula

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.


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Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of High-flow Nasal Cannula Therapy on Exposure to Nasal Continuous Positive Airway Pressure in Very Preterm Infants
Study Start Date : January 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 Name: HFNC




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007056


Locations
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France
Hopital de la croix rousse
Lyon, France, 69004
Sponsors and Collaborators
Hôpital de la Croix-Rousse
Investigators
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Principal Investigator: jean-charles picaud, MD, PhD Hopital de la croix rousse

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Responsible Party: Jean-charles PICAUD, MD, PhD, Professor of pediatrics, Hôpital de la Croix-Rousse
ClinicalTrials.gov Identifier: NCT03007056     History of Changes
Other Study ID Numbers: HIFLO
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jean-charles PICAUD, MD, PhD, Hôpital de la Croix-Rousse:
high flow nasal cannula
nasal continuous positive airway pressure
noninvasive ventilatory support
newborn developmental care
bronchopulmonary dysplasia
weaning
pain
length of stay