High Flow Nasal Cannula in Preterm Infants

NCT ID: NCT03007056

Last Updated: 2017-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Prematurity; Extreme

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Period 1

year 2011 nCPAP

No interventions assigned to this group

Period 2

year 2014 nCPAP and high flow nasal cannula

High flow nasal cannula

Intervention Type OTHER

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

Interventions

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High flow nasal cannula

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

Intervention Type OTHER

Other Intervention Names

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HFNC

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital de la Croix-Rousse

OTHER

Sponsor Role lead

Responsible Party

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Jean-charles PICAUD, MD, PhD

Professor of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jean-charles picaud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital de la croix rousse

Locations

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Hopital de la croix rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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HIFLO

Identifier Type: -

Identifier Source: org_study_id

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