Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-03-14 @ 6:42 PM
Study NCT ID:
NCT02748720
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2016-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2016-04-04', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduce the need for surfactant.', 'timeFrame': 'through study completion, an average of 3 days', 'description': 'The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce the need for surfactant.'}], 'secondaryOutcomes': [{'measure': 'Need for intubation and intermittent mechanical ventilation (iMV)', 'timeFrame': 'through study completion, an average of 3 days', 'description': 'Avoid intubation and Invasive Mechanical Ventilation in the next three days.'}, {'measure': 'Incidence of dysplasia bronchopulmonary', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Reduce incidence of dysplasia bronchopulmonary'}, {'measure': 'CPAP on admission to NICU', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'Number of newborn with CPAP on admission to NICU'}, {'measure': 'Incidence of mortality', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Measure and get desired tidal volume to optimize resuscitation', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Number of leaks and obstruction during ventilation mask', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce number of leaks and obstruction during mask ventilation and improves and set the desired tidal volume to optimize resuscitation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Premature', 'Respiratory Function Monitor'], 'conditions': ['Infant, Premature']}, 'descriptionModule': {'briefSummary': 'Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the time of transition at birth. For that stabilization during resuscitation is successful, it is essential for proper ventilation. This transition is performed with non-invasive respiratory support and administration of positive pressure ventilation to establish adequate functional residual capacity. The problem is that a peak inspiratory fixed during ventilation, and adequate tidal volume is assumed, but usually not measured, unable to correct the peak pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events may hinder or impair the effectiveness of the ventilation, with the consequent deterioration in the prognosis of the newborn.', 'detailedDescription': 'HYPOTHESIS The ability to visualize the parameters and curves respiratory flow, tidal volume and air pressure by respiratory monitoring with MFR during cardiopulmonary resuscitation in newborns in the delivery room, decreases at least 10% surfactant need in first 72 hours of life.\n\nEVALUATION Data collection will be made prospectively. Investigators will measure the parameters of lung mechanics (tidal volume expiratory airflow (TVe), peak inspiratory pressure (PIP), pressure at the end of exhalation (PEEP), inspiratory time (iT)), in each of inflations administered to preterm with VPP or during the administration of continuous positive airway pressure (CPAP) in spontaneous breathing, in the first 10 minutes after birth, recording the air leakage through the mask and obstructions. Investigators also measure parameters of respiratory status and hemodynamic (FIO 2, oxygen saturation, end tidal CO2, respiratory rate, heart rate), patient monitoring during the implementation of the protocol, blood gases, manipulations of the airway during intervention and the onset of complications.\n\nPatients will be randomize in a Group 1, where these parameters of lung mechanics would be visible and other Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants less than 32+6/7 weeks gestational age, birth requiring stabilization with VPP or CPAP in the delivery room.\n\nExclusion Criteria:\n\n* Congenital Malformations or Chromosomal Aberrations\n* Less Than 22 Weeks\n* Birth-weight less Than the Third Percentile for Gestational Age According to Spanish Curve\n* Severe Perinatal Asphyxia (Apgar Score of 0-3 More Than 5 Min, Cord Blood ph\\<7.00)\n* reanimation unrecorded with video\n* no obtained informed consent'}, 'identificationModule': {'nctId': 'NCT02748720', 'briefTitle': 'Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'Impact of Measurement of Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation', 'orgStudyIdInfo': {'id': '2014-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RFM Visible', 'description': 'Patients will be randomize in other Group 1, where these parameters (from the device Respiratory Function Monitor) of lung mechanics would be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). We adapt or change PIP using visible TVe.', 'interventionNames': ['Other: RFM (device) Visible']}, {'type': 'NO_INTERVENTION', 'label': 'RFM No Visible', 'description': 'Patients will be randomize in a Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks'}], 'interventions': [{'name': 'RFM (device) Visible', 'type': 'OTHER', 'description': 'Will measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume', 'armGroupLabels': ['RFM Visible']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'HGU Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Gonzalo Zeballos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gregorio Marañón Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manuel Sanchez Luna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Manuel Sanchez Luna', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}