Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02014493
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2013-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Respiratory Effort in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2013-12-04', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neural control of respiration', 'timeFrame': '4 months', 'description': 'reflected by electrical activity of the diaphragm (Edi): inspiratory drive (Edi peak) and tonic activity (Edi min). A nasogastric feeding tube with ten microsensors will measure action potentials from the phrenic nerve to the diaphragm.'}], 'secondaryOutcomes': [{'measure': 'Respiratory signs', 'timeFrame': '4 months', 'description': 'Observation scale inspired by Silverman- Anderson retraction score. Observation of chest movement, intercostal retraction and xiphoid retraction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiration', 'Noninvasive Ventilation', 'Work of breathing', 'Infant, premature', 'Electromyography', 'Diaphragm'], 'conditions': ['Premature Birth']}, 'referencesModule': {'references': [{'pmid': '29504671', 'type': 'RESULT', 'citation': 'Brenne H, Grunewaldt KH, Follestad T, Bergseng H. A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. Acta Paediatr. 2018 Oct;107(10):1726-1732. doi: 10.1111/apa.14303. Epub 2018 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature respiratory center and having respiratory distress. CPAP requires intensive care monitoring and special qualified staff. Continuous positive pressure makes a constant noise around the child and can lead to an uncomfortable environment.The fixture of the binasal prongs can cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered important for the child.\n\nRecently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive care units.HFNC is considered to be easy to apply and a more comfortable respiratory support for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from intensive respiratory support, to prevent respiratory distress and as a respiratory support after extubation.\n\nThere is still uncertainty about safety and effectiveness of HFNC. The aim of this study is to investigate the preterm infants respiratory effort by measuring electrical activity in diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a scoring system inspired by Silverman- Andersen retraction score. It is expected that measured electrical activity in the diaphragm, measured respiratory parameters combined with bedside observations provide applicable knowledge about preterm infants respiratory effort in transition from CPAP to HFNC.', 'detailedDescription': 'Data material will be stored on a separate computer in a sheltered home Directory. All data will be anonymous. Edi signals are transported from Servo-I ventilator with neural access through a communication port to a personal computer.Respiratory parameters will be stored in Picis (High Performance Hospital Information System). For the Statistical analyzes a T-test will be carried out, and data from the pilot study will decide the power to see whether we reject or retain the 0 hypothesis: " There are no changes in the preterm infants respiratory effort in transition from CPAP to HFNC".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants who are stable on Nasal Continuous Positive Airway Pressure (nCPAP) with flow 8l/min\n* \\<34 and \\>28 gestational weeks, respiratory stable last 72 hours.\n* 1 kilo\n* Fi02\\< 30%\n* C02\\<9\n* written informed consent by parents/caregivers\n\nExclusion Criteria:\n\n* need for sedation\n* damage on the phrenic nerve\n* anomalies in the upper airways'}, 'identificationModule': {'nctId': 'NCT02014493', 'briefTitle': 'Changes in Respiratory Effort in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Respiratory Effort in Preterm Infants in the Transition From Continuous Positive Airway Pressure (CPAP) to High Flow Nasal Cannulae (HFNC)', 'orgStudyIdInfo': {'id': 'HHB-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HFNC first', 'description': '4 hours with High Flow Nasal Cannulae (HFNC) 6 l/pr.min, then 4 hours with Continuous Positive Airway Pressure (CPAP) 6l/pr.min.', 'interventionNames': ['Procedure: High Flow Nasal Cannulae (HFNC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CPAP first', 'description': '4 hours Continuous Positive Airway Pressure (CPAP) 6 l/pr.min, then 4 hours High Flow Nasal Cannulae (HFNC) 6 l/pr.min.', 'interventionNames': ['Procedure: Continuous Positive Airway Pressure (CPAP)']}], 'interventions': [{'name': 'High Flow Nasal Cannulae (HFNC)', 'type': 'PROCEDURE', 'description': 'HFNC 6 l/pr.min', 'armGroupLabels': ['HFNC first']}, {'name': 'Continuous Positive Airway Pressure (CPAP)', 'type': 'PROCEDURE', 'description': 'CPAP 6 l/pr.min', 'armGroupLabels': ['CPAP first']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Newborn Intensive Care Unit, St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Håkon Bergseng, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}