Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00443118
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2007-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eszyld@gmail.com', 'phone': '5491144093095', 'title': 'Edgardo Szyld MD, MSc', 'organization': 'FUNDASAMIN-Fundacion para la Salud Materno Infantil'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece', 'otherNumAtRisk': 511, 'otherNumAffected': 21, 'seriousNumAtRisk': 511, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'SIB - Self Inflating Bag With PEEP', 'description': 'Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve', 'otherNumAtRisk': 290, 'otherNumAffected': 25, 'seriousNumAtRisk': 290, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'SIB Without PEEP', 'description': 'Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve', 'otherNumAtRisk': 226, 'otherNumAffected': 19, 'seriousNumAtRisk': 226, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'bronchopulmonary dysplasia', 'notes': 'BPD defined as need for oxygen at 36 weeks GA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 290, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 226, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'mortality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 290, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 226, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'mortality'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to SIB with PEEP valve attached'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Subjects allocated to SIB-Without PEEP valve attached'}], 'classes': [{'categories': [{'measurements': [{'value': '93.7', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 minutes of life', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed by intention to treat'}, {'type': 'SECONDARY', 'title': 'Time the Newborn Takes to Reach a HR > 100 Bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag withouth a PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.6'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '1.8'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 minutes of life', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• SpO2 Value at 2 Minutes of Life.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to be ventilated using a Self Inlfating Bag with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Sujects allocated to be ventilated with Self Inflating Bag Without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'spread': '14', 'groupId': 'OG000'}, {'value': '80', 'spread': '20', 'groupId': 'OG001'}, {'value': '77', 'spread': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 minutes of life', 'unitOfMeasure': 'percentage of oxygen saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'the pulse-oximeter was reliable at 2 minutes in 69% of the cases in both groups.'}, {'type': 'SECONDARY', 'title': '• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag with a PEEP valve attached'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 2 minutes of life', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• Need for Chest Compression and/or Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to SIB with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Subjects Allocated to SIB without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 2 minutes of life', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apgar Scores at 1 and 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag Without PEEP valve'}], 'classes': [{'title': 'apgar score 1 min <=3', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}, {'title': 'apgar score 5 min <=5', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 minutes of life', 'description': 'categorized Apgar score 1 min \\<=3 and categorized Apgar score 5 min \\<=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Self Inflating Bag without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'first week of life', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• Incidence of Air Leaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Subjects allocated to SIB-Without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after birth and during hospitalization up to four weeks', 'description': 'included pneumothorax and Pneumomediastinum', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• Use of Oxygen Treatment Beyond the Delivery Room', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'subjects allocated to SIB-Without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during hospitalization', 'unitOfMeasure': 'participants/', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days on Oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'subjects allocated to SIB-Without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '17', 'groupId': 'OG000'}, {'value': '23', 'spread': '27', 'groupId': 'OG001'}, {'value': '23', 'spread': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after birth and during hospitalization up to four weeks', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• Need for Mechanical Ventilation or CPAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to SIB with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'subjects allocate to SIB Without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during hospitalization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days on Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Without PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Subjects allocated to SIB-Without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '7', 'spread': '11', 'groupId': 'OG001'}, {'value': '12', 'spread': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after delivery and before four weeks', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days on CPAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'OG001', 'title': 'SIB - Self Inflating Bag With PEEP Valve', 'description': 'Subjects allocated to Self Inflating Bag with PEEP valve'}, {'id': 'OG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Subjects allocated to be resuscitated with Self Inflating Bag Without PEEP valve'}], 'classes': [{'categories': [{'measurements': [{'value': '7.83', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '6.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after birth and during hospitalization up to four weeks', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Neopuff TM With PEEP', 'description': 'Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP\n\nT-piece resuscitator Neopuff TM: Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.'}, {'id': 'OG001', 'title': 'Self Inflating Bag With PEEP', 'description': 'Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached\n\nSelf Inflating Bag with PEEP: Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.'}, {'id': 'OG002', 'title': 'Self Inflating Bag Without PEEP', 'description': 'Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached\n\nSelf Inflating Bag without PEEP: Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day of life and 30 days after birth', 'description': 'Incidence of intracranial hemorrhage grades 3-4 for preterm newborns \\<32 weeks by ultrasound evaluation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'this is an analyisis among the subgroup of subjects \\<32 weeks GA. this is the population at risk of this outcome. It extremely unusual intracranial hemorrhage over 32 weeks GA.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'FG001', 'title': 'SIB - With PEEP Valve', 'description': 'Subjects allocated to SIB with a PEEP valve attached'}, {'id': 'FG002', 'title': 'SIB-Without PEEP Valve', 'description': 'Self inflating bag without PEEP valve'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '515'}, {'groupId': 'FG001', 'numSubjects': '291'}, {'groupId': 'FG002', 'numSubjects': '226'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '511'}, {'groupId': 'FG001', 'numSubjects': '290'}, {'groupId': 'FG002', 'numSubjects': '226'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'unknown primary outcome', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}, {'value': '1027', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'T-Piece', 'description': 'Subjects assigned to be resuscitated with T-Piece'}, {'id': 'BG001', 'title': 'Self Inflating Bag With PEEP', 'description': 'Subjects allocated to Self Inflating Bag with PEEP'}, {'id': 'BG002', 'title': 'Self Inflating Bag Without PEEP', 'description': 'Subjects allocated to Self Inflating Bag without PEEP'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '7', 'groupId': 'BG000'}, {'value': '28', 'spread': '7', 'groupId': 'BG001'}, {'value': '27', 'spread': '7', 'groupId': 'BG002'}, {'value': '28', 'spread': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Maternal age. As the subjects are all newborns, the baseline important data includes Maternal data', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '35', 'spread': '5', 'groupId': 'BG001'}, {'value': '37', 'spread': '4', 'groupId': 'BG002'}, {'value': '36', 'spread': '4.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Gestational age of enrolled infants', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '426', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '303', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '601', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'previous deliveries', 'classes': [{'title': 'primiparous', 'categories': [{'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '463', 'groupId': 'BG003'}]}]}, {'title': 'multiparous', 'categories': [{'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '564', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'number of participants'}, {'title': 'ANTENATAL STEROIDS', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '369', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '729', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1032}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2007-03-02', 'resultsFirstSubmitDate': '2014-02-22', 'studyFirstSubmitQcDate': '2007-03-02', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-30', 'studyFirstPostDateStruct': {'date': '2007-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.', 'timeFrame': '2 minutes of life'}], 'secondaryOutcomes': [{'measure': 'Time the Newborn Takes to Reach a HR > 100 Bpm', 'timeFrame': '2 minutes of life'}, {'measure': '• SpO2 Value at 2 Minutes of Life.', 'timeFrame': '2 minutes of life'}, {'measure': '• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.', 'timeFrame': 'after 2 minutes of life'}, {'measure': '• Need for Chest Compression and/or Medications', 'timeFrame': 'after 2 minutes of life'}, {'measure': 'Apgar Scores at 1 and 5 Minutes', 'timeFrame': '1-5 minutes of life', 'description': 'categorized Apgar score 1 min \\<=3 and categorized Apgar score 5 min \\<=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes.'}, {'measure': '• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)', 'timeFrame': 'first week of life'}, {'measure': '• Incidence of Air Leaks', 'timeFrame': 'after birth and during hospitalization up to four weeks', 'description': 'included pneumothorax and Pneumomediastinum'}, {'measure': '• Use of Oxygen Treatment Beyond the Delivery Room', 'timeFrame': 'during hospitalization'}, {'measure': 'Days on Oxygen', 'timeFrame': 'after birth and during hospitalization up to four weeks'}, {'measure': '• Need for Mechanical Ventilation or CPAP', 'timeFrame': 'during hospitalization'}, {'measure': 'Days on Mechanical Ventilation', 'timeFrame': 'after delivery and before four weeks'}, {'measure': 'Days on CPAP', 'timeFrame': 'after birth and during hospitalization up to four weeks'}, {'measure': '• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks', 'timeFrame': '1 day of life and 30 days after birth', 'description': 'Incidence of intracranial hemorrhage grades 3-4 for preterm newborns \\<32 weeks by ultrasound evaluation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bag and mask', 'Neopuff', 'Resuscitation', 'Newborn', 'Intubation', 'devices', 'PEEP'], 'conditions': ['Resuscitation']}, 'referencesModule': {'references': [{'pmid': '24690329', 'type': 'DERIVED', 'citation': 'Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J, Carlo WA; Delivery Room Ventilation Devices Trial Group. Comparison of devices for newborn ventilation in the delivery room. J Pediatr. 2014 Aug;165(2):234-239.e3. doi: 10.1016/j.jpeds.2014.02.035. Epub 2014 Mar 29.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/24690329', 'label': 'this paper was published on The Journal of Pediatrics'}]}, 'descriptionModule': {'briefSummary': 'A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation \\[PPV\\]) for resuscitation in the delivery room comparing a T-piece resuscitator device versus resuscitation bag.', 'detailedDescription': "Design: A multicenter cross-over cluster randomized controlled trial. Our hypothesis is based on the assumption that ventilating depressed newborns with a T-piece resuscitator will be more effective than SIB by increasing the proportion of resuscitated newborns with heart rate (HR) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation.\n\nPopulation: Newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (PPV) for resuscitation in the delivery room.\n\n(need for assisted ventilation at positive pressure: Heart Rate \\[HR\\] \\< 100 beats per minute \\[bpm\\], apnea, gasping, cyanosis and/or hypotonia)\n\nIntervention: PPV will be performed with a T-piece resuscitator (Neopuff® group) with positive end expiratory pressure.\n\nControl: PPV will be performed with a self inflating bag (SIB group) with and without PEEP.\n\nBoth devices will be used with face masks, and a peak inspiratory pressure (PIP) of 25 cm H2O will be used to begin ventilation with PEEP of 0 cm H2O in the subgroup without PEEP valve, 5 cm H2O in the subgroup with PEEP valve in the SIB group, and 5 cm H2O in the Neopuff® group.\n\nObjective: To compare the effectiveness of both instruments in reaching a heart rate of ≥ 100 bpm in depressed newborns of ≥ 26 weeks' gestational age (GA) after the initiation of positive pressure ventilation (PPV) with face mask.\n\nPrimary Outcome: Proportion of newborns with HR ≥ 100 bpm at 2 minutes of life.\n\nType of Comparison: Which of the two devices Neopuff TM or Self Inflating Bag (NP/SIB)will be more effective for ventilation of the newborn, by increasing the proportion of resuscitated newborns with heart rate (HR) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nLive-born infants of ≥ 26 weeks' GA with HR \\< 100 bpm requiring resuscitation with positive pressure ventilation with mask in the delivery room according to the current AAP/AHA recommendations\n\nExclusion Criteria:\n\nInfants requiring intubation from birth. Newborns of \\< 26 weeks´ GA. Newborns presenting major congenital malformations. Multiple births. Problems (difficulty or malfunctioning) with the device assigned."}, 'identificationModule': {'nctId': 'NCT00443118', 'briefTitle': 'Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?', 'nctIdAliases': ['NCT01126489'], 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Salud Materno Infantil'}, 'officialTitle': 'NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A T-PIECE RESUSCITATOR? Multicenter Cross-over Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Fundasamin 102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neopuff TM with PEEP', 'description': 'Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP', 'interventionNames': ['Device: T-piece resuscitator Neopuff TM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self Inflating Bag with PEEP', 'description': 'Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached', 'interventionNames': ['Device: Self Inflating Bag with PEEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self Inflating Bag without PEEP', 'description': 'Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached', 'interventionNames': ['Device: Self Inflating Bag without PEEP']}], 'interventions': [{'name': 'T-piece resuscitator Neopuff TM', 'type': 'DEVICE', 'description': 'Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.', 'armGroupLabels': ['Neopuff TM with PEEP']}, {'name': 'Self Inflating Bag with PEEP', 'type': 'DEVICE', 'otherNames': ['Ambu'], 'description': 'Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.', 'armGroupLabels': ['Self Inflating Bag with PEEP']}, {'name': 'Self Inflating Bag without PEEP', 'type': 'DEVICE', 'otherNames': ['Ambu'], 'description': 'Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.', 'armGroupLabels': ['Self Inflating Bag without PEEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19676', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "Carol Jo Vecchie Women and Children's Center at St. John's Hospital", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': 'C1425FSD', 'city': 'Ciudad de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanatorio de los Arcos'}, {'city': 'Pilar', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Universitario Austral', 'geoPoint': {'lat': -34.45867, 'lon': -58.91398}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital Misericordia', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '4400', 'city': 'Salta', 'country': 'Argentina', 'facility': 'Nuevo Hospital El Milagro de Salta', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'zip': '8330024', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Clínico de la Pontificia Universidad Católica de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Temuco', 'country': 'Chile', 'facility': 'Hospital Dr. Hernán Henriquez Aravena', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'city': 'Viña del Mar', 'country': 'Chile', 'facility': 'Hospital Dr. Gustavo Fricke', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '35128', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto Nacional Materno Perinatal (INMP) de Perú', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Edgardo Szyld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundasamin'}, {'name': 'Adriana Aguilar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Paroissien'}, {'name': 'Waldemar Carlo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Nestor Vain, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanatorio de la Trinidad'}, {'name': 'Luis Prudent, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanatorio Otamendi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edgardo Szyld', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Edgardo Szyld', 'investigatorAffiliation': 'Fundacion para la Salud Materno Infantil'}}}}