Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT00724594
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2008-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002821', 'term': 'Chorioamnionitis'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jenkd@musc.edu', 'phone': '843-792-4341', 'title': 'Dr. Dorothea Jenkins', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Mothers were monitored for Adverse Events for up to 2 days after treatment. Infants were assessed for Adverse Events until discharge, Serious Adverse Events up to 30 days post-treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'NAC Infant', 'description': 'Infants treated with N-acetylcysteine', 'otherNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Control Infant', 'description': 'Infants treated with saline', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'NAC Maternal', 'description': 'Mothers of infants treated with N-acetylcysteine', 'otherNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control Maternal', 'description': 'Mothers of infants treated with saline', 'otherNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash/Hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath/wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolonged PT time', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Resuscitation-chest compressions/CV meds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IVH 1-2 days of age', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IVH 5-7 days of age', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NEC within 30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxic Ischemic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Culture Proven Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'NAC Terminal Elimination Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Maternal', 'description': 'Mothers treated with N-acetylcysteine prior to delivery of infant'}, {'id': 'OG001', 'title': 'NAC Preterm Infants', 'description': 'Preterm infants treated with N-acetylcysteine'}, {'id': 'OG002', 'title': 'NAC Term Infants', 'description': 'Term infants treated with N-acetylcysteine'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'NAC Volume of Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Maternal', 'description': 'Mothers treated with N-acetylcysteine prior to delivery of infant'}, {'id': 'OG001', 'title': 'NAC Preterm Infants', 'description': 'Preterm infants treated with N-acetylcysteine'}, {'id': 'OG002', 'title': 'NAC Term Infants', 'description': 'Term infants treated with N-acetylcysteine'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion', 'unitOfMeasure': 'L/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'NAC Total Body Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Maternal', 'description': 'Mothers treated with N-acetylcysteine prior to delivery of infant'}, {'id': 'OG001', 'title': 'NAC Preterm Infants', 'description': 'Preterm infants treated with N-acetylcysteine'}, {'id': 'OG002', 'title': 'NAC Term Infants', 'description': 'Term infants treated with N-acetylcysteine'}], 'classes': [{'categories': [{'measurements': [{'value': '255', 'spread': '61', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '53.7', 'spread': '11.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion', 'unitOfMeasure': 'mL/h/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'NAC Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Maternal', 'description': 'Mothers treated with N-acetylcysteine prior to delivery'}, {'id': 'OG001', 'title': 'NAC Preterm Infants', 'description': 'Preterm infants treated with N-acetylcysteine'}, {'id': 'OG002', 'title': 'NAC Term Infants', 'description': 'Term infants treated with N-acetylcysteine'}], 'classes': [{'title': 'Peak NAC concentration in plasma', 'categories': [{'measurements': [{'value': '1222', 'spread': '415', 'groupId': 'OG000'}, {'value': '49.0', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '92.3', 'spread': '69.2', 'groupId': 'OG002'}]}]}, {'title': 'NAC cord concentration', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable to mothers', 'groupId': 'OG000'}, {'value': '370.7', 'spread': '199.2', 'groupId': 'OG001'}, {'value': '639.7', 'spread': '409.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Peak: 30 minutes after NAC infusion. Cord: at delivery', 'unitOfMeasure': 'micromol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Placental Transfer Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Maternal', 'description': 'Mothers treated with N-acetylcysteine prior to birth'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of delivery', 'description': 'Ratio of NAC concentration in cord to maternal venous blood', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Maternal and Infant Mean Blood Pressure Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Infants', 'description': 'Infants treated with N-acetylcysteine'}, {'id': 'OG001', 'title': 'Control Infants', 'description': 'Infants treated with saline'}, {'id': 'OG002', 'title': 'NAC Maternal', 'description': 'Mothers treated with N-acetylcysteine prior to delivery'}, {'id': 'OG003', 'title': 'Control Maternal', 'description': 'Mothers treated with saline prior to delivery'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '13', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '11', 'groupId': 'OG001'}, {'value': '1', 'spread': '12', 'groupId': 'OG002'}, {'value': '2', 'spread': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The infant and maternal populations analyzed for this portion are incomplete, as not all individuals had paired before/after blood pressure measurements at this time point.'}, {'type': 'PRIMARY', 'title': 'Cerebral Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Term Infants', 'description': 'Term Infants treated with N-acetylcysteine'}, {'id': 'OG001', 'title': 'Control Term Infants', 'description': 'Term Infants treated with saline'}, {'id': 'OG002', 'title': 'NAC Preterm Infants', 'description': 'Preterm Infants treated with N-acetylcysteine'}, {'id': 'OG003', 'title': 'Control Preterm Infants', 'description': 'Preterm Infants treated with saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '0.99'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.81', 'upperLimit': '0.97'}, {'value': '0.92', 'groupId': 'OG002', 'lowerLimit': '0.88', 'upperLimit': '0.97'}, {'value': '0.89', 'groupId': 'OG003', 'lowerLimit': '0.82', 'upperLimit': '0.95'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'not significant', 'groupDescription': 'Term infant cohort : NAC vs control H0= there will be no difference in resistive index in Middle Cerebral Artery after N-acetylcysteine or saline in the term cohort.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Preterm infant cohort: NAC vs control H0= there will be no difference in resisitive index in MCA after N-acetylcysteine or saline in preterm cohort', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'after NAC infusion', 'description': 'Resistive index in middle cerebral artery (MCA)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'blood flow resistive indices after first dose of N-acetylcysteine or saline'}, {'type': 'PRIMARY', 'title': 'Prothrombin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Infant', 'description': 'Infants treated with N-acetylcysteine'}, {'id': 'OG001', 'title': 'Control Infant', 'description': 'Infants treated with saline'}, {'id': 'OG002', 'title': 'NAC Maternal', 'description': 'Mothers of infants treated with N-acetylcysteine'}, {'id': 'OG003', 'title': 'Control Maternal', 'description': 'Mothers of infants treated with saline'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '14.4', 'spread': '1.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'not significant', 'groupDescription': 'Maternal cohort: NAC versus control l H0= PT will not be different in mothers after NAC or saline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Infant cohort: NAC versus control H0= prothrombin time will not be different in the infants after NAC or saline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'after N-acetylcystiene or saline infusion', 'description': 'prothrombin clotting time', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Magnetic Resonance Spectroscopy of Infants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Infants'}, {'id': 'OG001', 'title': 'Control Infants'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'correcting for gestational age at birth', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '36 - 40 weeks gestational age', 'description': 'ratio of myoInositol / NAA concentrations in basal ganglia', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cytokine Level IL-1Ra in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NAC Infants'}, {'id': 'OG001', 'title': 'Control Infants'}], 'classes': [{'categories': [{'measurements': [{'value': '745', 'groupId': 'OG000', 'lowerLimit': '251', 'upperLimit': '1302'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '448'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'after N-acetylcysteine infusion', 'description': 'anti-inflammatory cytokine Interleukin -1 Receptor alpha (IL-1Ra)', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NAC Infant', 'description': 'Infants treated with N-acetylcysteine'}, {'id': 'FG001', 'title': 'Control Infant', 'description': 'Infants treated with saline'}, {'id': 'FG002', 'title': 'NAC Maternal', 'description': 'Mothers of infants treated with N-acetylcysteine'}, {'id': 'FG003', 'title': 'Control Maternal', 'description': 'Mothers of infants treated with saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Due two enrolling two sets of twins (one set in the preterm/NAC group, and one set in the preterm/control group), our study included 24 infants and 22 mothers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'NAC Infant', 'description': 'Infants treated with N-acetylcysteine'}, {'id': 'BG001', 'title': 'Control Infant', 'description': 'Infants treated with saline'}, {'id': 'BG002', 'title': 'NAC Maternal', 'description': 'Mothers of infants treated with N-acetylcysteine'}, {'id': 'BG003', 'title': 'Control Maternal', 'description': 'Mothers of infants treated with saline'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Preterm Infants', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Only applicable to infants', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Only applicable to infants', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG004'}]}]}, {'title': 'Term Infants', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Only applicable to infants', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Only applicable to infants', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG004'}]}]}, {'title': 'Mothers aged 18-45years', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Only applicable to mothers', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Only applicable to mothers', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2008-07-28', 'resultsFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-15', 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NAC Terminal Elimination Half-life', 'timeFrame': 'prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion'}, {'measure': 'NAC Volume of Distribution', 'timeFrame': 'prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion'}, {'measure': 'NAC Total Body Clearance', 'timeFrame': 'prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion'}, {'measure': 'NAC Concentrations', 'timeFrame': 'Peak: 30 minutes after NAC infusion. Cord: at delivery'}, {'measure': 'Placental Transfer Ratio', 'timeFrame': 'At time of delivery', 'description': 'Ratio of NAC concentration in cord to maternal venous blood'}, {'measure': 'Maternal and Infant Mean Blood Pressure Change', 'timeFrame': 'Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing'}, {'measure': 'Cerebral Blood Flow', 'timeFrame': 'after NAC infusion', 'description': 'Resistive index in middle cerebral artery (MCA)'}, {'measure': 'Prothrombin Time', 'timeFrame': 'after N-acetylcystiene or saline infusion', 'description': 'prothrombin clotting time'}], 'secondaryOutcomes': [{'measure': 'Magnetic Resonance Spectroscopy of Infants', 'timeFrame': '36 - 40 weeks gestational age', 'description': 'ratio of myoInositol / NAA concentrations in basal ganglia'}, {'measure': 'Cytokine Level IL-1Ra in Plasma', 'timeFrame': 'after N-acetylcysteine infusion', 'description': 'anti-inflammatory cytokine Interleukin -1 Receptor alpha (IL-1Ra)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chorioamnionitis', 'maternal chorioamnionitis', 'neonatal white matter injury', 'N-acetylcysteine', 'NAC', 'anti-oxidant treatment'], 'conditions': ['Chorioamnionitis', 'Brain Injury']}, 'referencesModule': {'references': [{'pmid': '25064164', 'type': 'RESULT', 'citation': 'Wiest DB, Chang E, Fanning D, Garner S, Cox T, Jenkins DD. Antenatal pharmacokinetics and placental transfer of N-acetylcysteine in chorioamnionitis for fetal neuroprotection. J Pediatr. 2014 Oct;165(4):672-7.e2. doi: 10.1016/j.jpeds.2014.06.044. Epub 2014 Jul 23.'}, {'pmid': '26545726', 'type': 'DERIVED', 'citation': 'Jenkins DD, Wiest DB, Mulvihill DM, Hlavacek AM, Majstoravich SJ, Brown TR, Taylor JJ, Buckley JR, Turner RP, Rollins LG, Bentzley JP, Hope KE, Barbour AB, Lowe DW, Martin RH, Chang EY. Fetal and Neonatal Effects of N-Acetylcysteine When Used for Neuroprotection in Maternal Chorioamnionitis. J Pediatr. 2016 Jan;168:67-76.e6. doi: 10.1016/j.jpeds.2015.09.076. Epub 2015 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial was to find the best dose of N-acetylcysteine (NAC) to decrease brain injury in babies exposed to intrauterine infection without causing significant side effects.', 'detailedDescription': 'Chorioamnionitits is an infection in the fluid and membranes surrounding the baby in utero. Intrauterine infection is associated with significant white and grey matter brain injury in newborns and is particularly important in the pathogenesis of periventricular leukomalacia (PVL) and cerebral palsy (CP). CP has been shown to be 4-9 times higher in babies exposed to intrauterine infection than in normal infants. Antibiotics have not changed the risk for brain injury in the newborn.\n\nNAC is a promising anti-oxidant therapy that has shown effective neuroprotection in an animal model of chorioamnionitis, and has a favorable safety profile with limited and manageable side effects.\n\nIn this trial, intravenous NAC was given to mothers antenatally and to their infants postnatally, who presented with the diagnosis of chorioamnionitis, to evaluate safety and pharmacokinetics (PK) in mothers and infants. Mothers at ≥24 weeks gestation and their infants were randomized to receive either saline NAC within 4 hours of a clinical diagnosis of chorioamnionitis. Infants were stratified into term (≥ 33wk) and preterm (24-32wk) cohorts, due to different expected rates of metabolism and clearance.\n\nInformation gained from this trial will be used to determine how rapidly NAC is metabolized by mother, fetus, infant, and the ability of NAC to cross placenta. This study will also elucidate the safety of NAC in the setting of chorioamnionitis for fetal neuroprotection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants had all of the following to qualify:\n\n* Chorioamnionitis, defined as either 1) clinical diagnosis of choriomanionitis 2) maternal fever greater than or equal to 100 degrees F in the presence of rupture of membranes or 2 of the following: uterine tenderness, maternal WBC \\> 15,000 cells/mm, fetal tachycardia \\> 160 bpm, malodorous amniotic fluid, or in preterm group only, rupture of membranes and active preterm labor.\n* Gestational age ≥ 24 completed weeks, by first trimester ultrasound or date of last menstrual period.\n* No greater than 4 hours from onset of fever or diagnosis.\n\nExclusion Criteria:\n\nParticipants had none of the following:\n\n* Asthma, steroid-dependent\n* Clinical sepsis, whether viral or bacterial in nature, defined as fever with signs of cardiovascular compromise in mother (blood pressure \\< 90/50, heart rate \\> 120 bpm, need for oxygen due to maternal saturations below 92%, pneumonia, pyelonephritis, or meningitis)\n* Seizure disorder\n* Fetal weight or biparietal diameter less than the 10th% for gestational age\n* Suspected major genetic or congenital abnormality\n* Fetal distress which demands immediate delivery (poor fetal biophysical profile, late decelerations, sinusoidal fetal heart rate pattern)\n* Participation in another therapeutic clinical trial'}, 'identificationModule': {'nctId': 'NCT00724594', 'briefTitle': 'Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Safety of N-acetylcysteine in Maternal Chorioamnionitis', 'orgStudyIdInfo': {'id': 'R01NS052448', 'link': 'https://reporter.nih.gov/quickSearch/R01NS052448', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01NS052448', 'link': 'https://reporter.nih.gov/quickSearch/R01NS052448', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N-acetylcysteine', 'description': 'Mother/infant pairs were stratified by gestational age into premature (P) and term (T) cohorts.', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Mother/infant pairs were stratified by gestational age into premature (P) and term (T) cohorts.', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'otherNames': ['Acetadote, NAC'], 'description': 'NAC (100 mg/kg/dose) was given intravenously to mothers within 4 hours of diagnosis of chorioamnionitis, and every 6 hours until delivery. NAC was given to preterm (12.5 mg/kg/dose) and term infants (25 mg/kg/dose) every 12 hours for 5 doses after birth.', 'armGroupLabels': ['N-acetylcysteine']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Saline was given in the same volume, at the same timing as NAC infusions', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Dorothea D. Jenkins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Eugene Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina (Obstetric Principal Investigator)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dorothea D. Jenkins', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}