Clinical Trials Directory

Trials / Completed

CompletedNCT03007056

High Flow Nasal Cannula in Preterm Infants

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

Status
Completed
Phase
Study type
Observational
Enrollment
207 (actual)
Sponsor
Hôpital de la Croix-Rousse · Academic / Other
Sex
All
Age
1 Day – 6 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERHigh flow nasal cannulaHigh flow nasal cannula added to the therapeutic arsenal in neonatal care

Timeline

Start date
2011-01-01
Primary completion
2014-12-01
Completion
2016-09-01
First posted
2017-01-02
Last updated
2017-01-02

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03007056. Inclusion in this directory is not an endorsement.