Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-24 @ 7:55 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-27', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-12-27', 'lastUpdatePostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of exposure to nCPAP, expressed in days in the population of very preterm infants.', 'timeFrame': '2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Duration of oxygen therapy (expressed in days) in the population of very preterm infants.', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'Duration of hospital stay (expressed in days) in the population of very preterm infants.', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'Duration of exposure to nCPAP (expressed in days) in extremely preterm infants.', 'timeFrame': '2 years', 'description': 'It will be the same evaluation than in whole population, but in extremely preterm infants borm before 29 weeks gestational age.'}, {'measure': 'The cost of use (expressed in Euros) of nCPAP and HFNC using two different devices.', 'timeFrame': '2 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['high flow nasal cannula', 'nasal continuous positive airway pressure', 'noninvasive ventilatory support', 'newborn developmental care', 'bronchopulmonary dysplasia', 'weaning', 'pain', 'length of stay'], 'conditions': ['Prematurity; Extreme']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nHIFLO 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born before 32 weeks of gestational age\n* Birth weight below 1500 g\n* Infants hospitalized within the first 48 hours of life\n* Infants discharged home from our unit\n\nExclusion Criteria:\n\n* Infants transferred to another unit\n* Infants with a severe malformation\n* Infants requiring surgery'}, 'identificationModule': {'nctId': 'NCT03007056', 'acronym': 'HIFLO', 'briefTitle': 'High Flow Nasal Cannula in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital de la Croix-Rousse'}, 'officialTitle': 'Effect of High-flow Nasal Cannula Therapy on Exposure to Nasal Continuous Positive Airway Pressure in Very Preterm Infants', 'orgStudyIdInfo': {'id': 'HIFLO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Period 1', 'description': 'year 2011 nCPAP'}, {'label': 'Period 2', 'description': 'year 2014 nCPAP and high flow nasal cannula', 'interventionNames': ['Other: High flow nasal cannula']}], 'interventions': [{'name': 'High flow nasal cannula', 'type': 'OTHER', 'otherNames': ['HFNC'], 'description': 'High flow nasal cannula added to the therapeutic arsenal in neonatal care', 'armGroupLabels': ['Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital de la croix rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'jean-charles picaud, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital de la croix rousse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital de la Croix-Rousse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of pediatrics', 'investigatorFullName': 'Jean-charles PICAUD, MD, PhD', 'investigatorAffiliation': 'Hôpital de la Croix-Rousse'}}}}