Clinical trial NCT03007056: High Flow Nasal Cannula in Preterm Infants
Official title: Effect of High-flow Nasal Cannula Therapy on Exposure to Nasal Continuous Positive Airway Pressure in Very Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity; Extreme
Keywords: high flow nasal cannula
nasal continuous positive airway pressure
noninvasive ventilatory support
newborn developmental care
bronchopulmonary dysplasia
weaning
pain
length of stay
Lead sponsor: Hôpital de la Croix-Rousse
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 207
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Duration of exposure to nCPAP, expressed in days in the population of very preterm infants.
timeFrame: 2 years
Secondary outcomes:
measure: Duration of oxygen therapy (expressed in days) in the population of very preterm infants.
timeFrame: 2 years
measure: Duration of hospital stay (expressed in days) in the population of very preterm infants.
timeFrame: 2 years
measure: Duration of exposure to nCPAP (expressed in days) in extremely preterm infants.
timeFrame: 2 years
measure: The cost of use (expressed in Euros) of nCPAP and HFNC using two different devices.
timeFrame: 2 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la croix rousse
Study officials:
affiliation: Hopital de la croix rousse
name: jean-charles picaud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: