Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT03007056
Status:
COMPLETED
Last Update Posted:
2017-01-02
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula in Preterm Infants
Sponsor:
Hôpital de la Croix-Rousse
Organization:
Study Overview
Official Title:
Effect of High-flow Nasal Cannula Therapy on Exposure to Nasal Continuous Positive Airway Pressure in Very Preterm Infants
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIFLO
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: