Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT03592134
Status:
UNKNOWN
Last Update Posted:
2018-07-19
First Post:
2018-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-11-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal variation of esophageal pressure', 'timeFrame': 'at participant inclusion day 1', 'description': 'Maximal variation of esophageal pressure will be compared for the different respiratory supports and the different settings'}], 'secondaryOutcomes': [{'measure': 'occurrence of bronchopulmonary dysplasia at 36 Gestational age (GA)', 'timeFrame': "From 2 to 7 weeks after participant's inclusion (day 1)"}, {'measure': 'need for nutritional support', 'timeFrame': "From 2 to 7 weeks after participant's inclusion (day 1)"}, {'measure': 'definitive weaning delay', 'timeFrame': "From 2 to 7 weeks after participant's inclusion (day 1)", 'description': 'weaning from noninvasive respiratory support and oxygen supplementation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Infant', 'Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '15858606', 'type': 'RESULT', 'citation': 'Liptsen E, Aghai ZH, Pyon KH, Saslow JG, Nakhla T, Long J, Steele AM, Habib RH, Courtney SE. Work of breathing during nasal continuous positive airway pressure in preterm infants: a comparison of bubble vs variable-flow devices. J Perinatol. 2005 Jul;25(7):453-8. doi: 10.1038/sj.jp.7211325.'}, {'pmid': '26769758', 'type': 'RESULT', 'citation': 'Shetty S, Hickey A, Rafferty GF, Peacock JL, Greenough A. Work of breathing during CPAP and heated humidified high-flow nasal cannula. Arch Dis Child Fetal Neonatal Ed. 2016 Sep;101(5):F404-7. doi: 10.1136/archdischild-2015-309310. Epub 2016 Jan 14.'}, {'pmid': '24071905', 'type': 'RESULT', 'citation': 'de Jongh BE, Locke R, Mackley A, Emberger J, Bostick D, Stefano J, Rodriguez E, Shaffer TH. Work of breathing indices in infants with respiratory insufficiency receiving high-flow nasal cannula and nasal continuous positive airway pressure. J Perinatol. 2014 Jan;34(1):27-32. doi: 10.1038/jp.2013.120. Epub 2013 Sep 26.'}, {'pmid': '16688202', 'type': 'RESULT', 'citation': 'Saslow JG, Aghai ZH, Nakhla TA, Hart JJ, Lawrysh R, Stahl GE, Pyon KH. Work of breathing using high-flow nasal cannula in preterm infants. J Perinatol. 2006 Aug;26(8):476-80. doi: 10.1038/sj.jp.7211530. Epub 2006 May 11.'}]}, 'descriptionModule': {'briefSummary': "Noninvasive respiratory supports (NRS), such as continuous positive airway pressure (CPAP), noninvasive ventilation, high flow nasal cannula (HFNC) or nasal oxygen (O2), are commonly used in preterm newborns hospitalized in neonatal intensive care unit. However, given the lack of validated criteria, clinicians usually choose the NRS according to clinical parameters and patients' comfort. Several studies have demonstrated the interest of the measurement of the work of breathing (WOB) to optimize the settings of NRS in children, but no study has already demonstrated the utility of WOB to optimize the settings of NRS in preterm infants. Therefore, the aim of this study is to measure the WOB during the utilisation of three different NRS (CPAP, HFNC, O2), in order to optimize the choice of the type and settings of NRS in a randomized group of 30 newborns born prematurely before 30 gestational weeks and still requiring NRS at 29 post conceptual weeks. Moreover, the investigators will compare in the newborns with the optimized NRS by WOB vs. a standard care control group (NRS type and settings determined as clinical routine): 1) the respiratory morbidity and mortality one month after the initial assessment, and at the time of hospital discharge (or transfer) or at 36 weeks of age corrected (whatever comes first), 2) the weaning time of the NRS, 3) the incidence and severity of broncho-pulmonary dysplasia (BPD) at 36 weeks of age corrected. Indeed, incidence of BPD is still around 40% in premature infants born before 28 gestational weeks. The hypothesis of the investigators' study is that the optimization of the type and settings of the NRS could reduce the weaning delay and contribute to reduce the incidence and severity of BPD in premature newborns."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'minimumAge': '4 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants needing a non invasive respiratory support after 4 weeks of life', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants born between 23 and 30 GA\n* Aged over 29 weeks of corrected age at the time of assessment and needing a non invasive respiratory support since at least 4 weeks of age\n\nExclusion Criteria:\n\n* Hemodynamic and/or neurologic instability\n* Invasive ventilation\n* Congenital cardiopathy and/or significant patent ductus arteriosus\n* Sedation\n* Congenital pulmonary disease and/or other malformations'}, 'identificationModule': {'nctId': 'NCT03592134', 'briefTitle': 'Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Necker-Enfants Malades'}, 'officialTitle': 'Choice and Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns < 30 Gestational Weeks', 'orgStudyIdInfo': {'id': '2017-A00535-48'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical settings', 'description': 'Infants with the choice of the non respiratory support and settings of the non respiratory support defined by clinical practice (nocturnal gas exchange, apneas, bradycardia, oxygen desaturation)'}, {'label': 'Physiological settings', 'description': 'Infants with the choice of the non respiratory support and settings of the non respiratory support defined by the measurement of work of breathing', 'interventionNames': ['Other: esophageal pressure measurement']}], 'interventions': [{'name': 'esophageal pressure measurement', 'type': 'OTHER', 'description': 'Measurement of esophageal pressure to determine the optimal non invasive respiratory support', 'armGroupLabels': ['Physiological settings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brigitte Fauroux, MD, PhD', 'role': 'CONTACT', 'email': 'brigitte.fauroux@aphp.fr', 'phone': '+33144496092'}], 'facility': 'AP-HP Hopital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Brigitte Fauroux, MD, PhD', 'role': 'CONTACT', 'email': 'brigitte.fauroux@aphp.fr', 'phone': '+33144496092'}, {'name': 'Sonia Khirani, PhD', 'role': 'CONTACT', 'email': 'sonia_khirani@yahoo.fr', 'phone': '+33144494091'}], 'overallOfficials': [{'name': 'Brigitte Fauroux, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP Hopital Necker'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Necker-Enfants Malades', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Brigitte Fauroux', 'investigatorAffiliation': 'Hôpital Necker-Enfants Malades'}}}}