Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-05 @ 2:55 AM
Study NCT ID:
NCT02492269
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2015-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Aymen.Naguib@nationwidechildrens.org', 'phone': '614-722-4200', 'title': 'Dr. Aymen Naguib', 'organization': "Nationwide Children's Hosp."}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 hours after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl\n\nDexmedetomidine', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl\n\nPlacebo', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cytokine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl\n\nDexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl\n\nPlacebo'}], 'classes': [{'title': 'Baseline TNF-alpha', 'categories': [{'measurements': [{'value': '4.38', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'Post-sternotomy TNF-alpha', 'categories': [{'measurements': [{'value': '3.98', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '3.85', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': 'Post-bypass TNF-alpha', 'categories': [{'measurements': [{'value': '2.88', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'End of surgery TNF-alpha', 'categories': [{'measurements': [{'value': '3.12', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': '24 hr. post-op TNF-alph', 'categories': [{'measurements': [{'value': '2.68', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Baseline IL-6', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Post-sternotomy IL-6', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Post-bypass IL-6', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'End of surgery IL-6', 'categories': [{'measurements': [{'value': '11.95', 'spread': '21.71', 'groupId': 'OG000'}, {'value': '11.32', 'spread': '14.73', 'groupId': 'OG001'}]}]}, {'title': '24 hr. post-op IL-6', 'categories': [{'measurements': [{'value': '30.2', 'spread': '17.04', 'groupId': 'OG000'}, {'value': '41.93', 'spread': '74.34', 'groupId': 'OG001'}]}]}, {'title': 'Baseline IL-8', 'categories': [{'measurements': [{'value': '6.55', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '5.61', 'groupId': 'OG001'}]}]}, {'title': 'Post-sternotomy IL-8', 'categories': [{'measurements': [{'value': '6.8', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '8.46', 'spread': '6.03', 'groupId': 'OG001'}]}]}, {'title': 'Post-bypass IL-8', 'categories': [{'measurements': [{'value': '7.04', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '8.35', 'spread': '5.94', 'groupId': 'OG001'}]}]}, {'title': 'End of surgery IL-8', 'categories': [{'measurements': [{'value': '28.83', 'spread': '28.97', 'groupId': 'OG000'}, {'value': '34.37', 'spread': '32.76', 'groupId': 'OG001'}]}]}, {'title': '24 hr. post-op IL-8', 'categories': [{'measurements': [{'value': '20.86', 'spread': '16.76', 'groupId': 'OG000'}, {'value': '32.52', 'spread': '29.81', 'groupId': 'OG001'}]}]}, {'title': 'Baseline IL-10', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Post-sternotomy IL-10', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Post-bypass IL-10', 'categories': [{'measurements': [{'value': '1.05', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'End of surgery IL-10', 'categories': [{'measurements': [{'value': '44.41', 'spread': '48.95', 'groupId': 'OG000'}, {'value': '78.27', 'spread': '54.11', 'groupId': 'OG001'}]}]}, {'title': '24 hr. post-op IL-10', 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 24 hrs post-op', 'description': 'Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Hormone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl\n\nDexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl\n\nPlacebo'}], 'classes': [{'title': 'Baseline ACTH', 'categories': [{'measurements': [{'value': '150.10', 'spread': '119.78', 'groupId': 'OG000'}, {'value': '139.48', 'spread': '96.11', 'groupId': 'OG001'}]}]}, {'title': 'Post-sternotomy ACTH', 'categories': [{'measurements': [{'value': '105.63', 'spread': '141.15', 'groupId': 'OG000'}, {'value': '94.2', 'spread': '93.8', 'groupId': 'OG001'}]}]}, {'title': 'Post-bypass ACTH', 'categories': [{'measurements': [{'value': '108.09', 'spread': '114.86', 'groupId': 'OG000'}, {'value': '199.34', 'spread': '160.34', 'groupId': 'OG001'}]}]}, {'title': 'End of surgery ACTH', 'categories': [{'measurements': [{'value': '186.69', 'spread': '170.06', 'groupId': 'OG000'}, {'value': '201.49', 'spread': '171.01', 'groupId': 'OG001'}]}]}, {'title': '24 hr. post-op ACTH', 'categories': [{'measurements': [{'value': '18.21', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '26.78', 'spread': '19.19', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Cortisol', 'categories': [{'measurements': [{'value': '448.27', 'spread': '187.73', 'groupId': 'OG000'}, {'value': '293.92', 'spread': '138.53', 'groupId': 'OG001'}]}]}, {'title': 'Post-sternotomy Cortisol', 'categories': [{'measurements': [{'value': '449.71', 'spread': '144.4', 'groupId': 'OG000'}, {'value': '316.58', 'spread': '264.12', 'groupId': 'OG001'}]}]}, {'title': 'Post-bypass Cortisol', 'categories': [{'measurements': [{'value': '314.42', 'spread': '81.66', 'groupId': 'OG000'}, {'value': '298.64', 'spread': '217.82', 'groupId': 'OG001'}]}]}, {'title': 'End of surgery Cortisol', 'categories': [{'measurements': [{'value': '553.88', 'spread': '220.52', 'groupId': 'OG000'}, {'value': '474.66', 'spread': '256.16', 'groupId': 'OG001'}]}]}, {'title': '24 hr. post-op Cortisol', 'categories': [{'measurements': [{'value': '344.83', 'spread': '344.79', 'groupId': 'OG000'}, {'value': '357.3', 'spread': '475.88', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Epinephrine', 'categories': [{'measurements': [{'value': '108.26', 'spread': '98.2', 'groupId': 'OG000'}, {'value': '112.13', 'spread': '145.52', 'groupId': 'OG001'}]}]}, {'title': 'Post-sternotomy Epinephrine', 'categories': [{'measurements': [{'value': '250.1', 'spread': '261.97', 'groupId': 'OG000'}, {'value': '379.68', 'spread': '344.15', 'groupId': 'OG001'}]}]}, {'title': 'Post-bypass Epinephrine', 'categories': [{'measurements': [{'value': '830.45', 'spread': '757.89', 'groupId': 'OG000'}, {'value': '830.73', 'spread': '488.22', 'groupId': 'OG001'}]}]}, {'title': 'End of surgery Epinephrine', 'categories': [{'measurements': [{'value': '203.73', 'spread': '103.58', 'groupId': 'OG000'}, {'value': '423.06', 'spread': '406.03', 'groupId': 'OG001'}]}]}, {'title': '24 hr. post-op Epinephrine', 'categories': [{'measurements': [{'value': '172.05', 'spread': '235.48', 'groupId': 'OG000'}, {'value': '154.05', 'spread': '176.39', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Norepinephrine', 'categories': [{'measurements': [{'value': '492.58', 'spread': '475.2', 'groupId': 'OG000'}, {'value': '696.5', 'spread': '568.89', 'groupId': 'OG001'}]}]}, {'title': 'Post-sternotomy Norepinephrine', 'categories': [{'measurements': [{'value': '545.88', 'spread': '656.81', 'groupId': 'OG000'}, {'value': '891.86', 'spread': '966.44', 'groupId': 'OG001'}]}]}, {'title': 'Post-bypass Norepinephrine', 'categories': [{'measurements': [{'value': '499.37', 'spread': '428.34', 'groupId': 'OG000'}, {'value': '1145.05', 'spread': '1281.1', 'groupId': 'OG001'}]}]}, {'title': 'End of surgery Norepinephrine', 'categories': [{'measurements': [{'value': '229.32', 'spread': '207.5', 'groupId': 'OG000'}, {'value': '477.66', 'spread': '745.6', 'groupId': 'OG001'}]}]}, {'title': '24 hr. post-op Norepinephrine', 'categories': [{'measurements': [{'value': '913.12', 'spread': '950.97', 'groupId': 'OG000'}, {'value': '1320.9', 'spread': '2263.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 24 hrs post-op', 'description': 'ACTH, cortisol, epinephrine, \\& norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Bayley Cognitive Composite Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl\n\nDexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '102.14', 'spread': '11.04', 'groupId': 'OG000'}, {'value': '95', 'spread': '16.12', 'groupId': 'OG001'}]}]}, {'title': 'Prior to discharge', 'categories': [{'measurements': [{'value': '102.14', 'spread': '13.26', 'groupId': 'OG000'}, {'value': '88.33', 'spread': '17.49', 'groupId': 'OG001'}]}]}, {'title': '1-3 month post-op', 'categories': [{'measurements': [{'value': '102.86', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '96.82', 'spread': '17.07', 'groupId': 'OG001'}]}]}, {'title': '6 months post-op', 'categories': [{'measurements': [{'value': '98.57', 'spread': '7.95', 'groupId': 'OG000'}, {'value': '97.27', 'spread': '16.49', 'groupId': 'OG001'}]}]}, {'title': '1 yr. post-op', 'categories': [{'measurements': [{'value': '94.64', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '94.09', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 1 year post-op', 'description': "Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.\n\nMean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.\n\nScore below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Bayley Language Composite Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl\n\nDexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '98.14', 'spread': '13.95', 'groupId': 'OG000'}, {'value': '86.81', 'spread': '14.45', 'groupId': 'OG001'}]}]}, {'title': 'Prior to discharge', 'categories': [{'measurements': [{'value': '91.14', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '77.6', 'spread': '12.26', 'groupId': 'OG001'}]}]}, {'title': '1-3 month post-op', 'categories': [{'measurements': [{'value': '92.5', 'spread': '13.35', 'groupId': 'OG000'}, {'value': '92.36', 'spread': '14.43', 'groupId': 'OG001'}]}]}, {'title': '6 months post-op', 'categories': [{'measurements': [{'value': '86', 'spread': '11.81', 'groupId': 'OG000'}, {'value': '91.36', 'spread': '8.98', 'groupId': 'OG001'}]}]}, {'title': '1 yr. post-op', 'categories': [{'measurements': [{'value': '93.08', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '91.2', 'spread': '18.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 1 year post-op', 'description': "Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.\n\nMean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.\n\nScore below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Bayley Motor Composite Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl\n\nDexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '95.14', 'spread': '15.02', 'groupId': 'OG000'}, {'value': '84.2', 'spread': '15.89', 'groupId': 'OG001'}]}]}, {'title': '1-3 month post-op', 'categories': [{'measurements': [{'value': '92.07', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '84.27', 'spread': '16.84', 'groupId': 'OG001'}]}]}, {'title': '6 months post-op', 'categories': [{'measurements': [{'value': '92', 'spread': '13.98', 'groupId': 'OG000'}, {'value': '87.18', 'spread': '10.66', 'groupId': 'OG001'}]}]}, {'title': '1 yr. post-op', 'categories': [{'measurements': [{'value': '91.69', 'spread': '10.62', 'groupId': 'OG000'}, {'value': '87.5', 'spread': '17.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 1 year post-op', 'description': "Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.\n\nMean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.\n\nScore below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl\n\nDexmedetomidine'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl\n\nDexmedetomidine'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'spread': '2', 'groupId': 'BG000'}, {'value': '6', 'spread': '2', 'groupId': 'BG001'}, {'value': '6', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Ventricular Septal Defect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Tetralogy of Fallot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Atrioventricular septal defect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'spread': '1', 'groupId': 'BG000'}, {'value': '7', 'spread': '1', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-05', 'size': 392436, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-18T11:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2015-07-03', 'resultsFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2015-07-03', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-21', 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cytokine Levels', 'timeFrame': 'From baseline to 24 hrs post-op', 'description': 'Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.'}, {'measure': 'Change in Hormone Levels', 'timeFrame': 'From baseline to 24 hrs post-op', 'description': 'ACTH, cortisol, epinephrine, \\& norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.'}, {'measure': 'Change in Bayley Cognitive Composite Scores', 'timeFrame': 'From baseline to 1 year post-op', 'description': "Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.\n\nMean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.\n\nScore below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment."}], 'secondaryOutcomes': [{'measure': 'Change in Bayley Language Composite Scores', 'timeFrame': 'From baseline to 1 year post-op', 'description': "Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.\n\nMean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.\n\nScore below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment."}, {'measure': 'Change in Bayley Motor Composite Scores', 'timeFrame': 'From baseline to 1 year post-op', 'description': "Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.\n\nMean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.\n\nScore below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with the following diagnosis:\n\n 1. ASD\n 2. VSD\n 3. AVSD\n 4. TOF\n 5. Biventricular repair with left to right shunt.\n\nExclusion Criteria:\n\n* Patients with the diagnosis of AVSD and pulmonary hypertension\n* Patients less than 1 year and require any of the following repairs:\n\n 1. HLHS\n 2. Aortic arch reconstruction\n 3. Arterial switch\n 4. TOF with pulmonary atresia'}, 'identificationModule': {'nctId': 'NCT02492269', 'briefTitle': 'Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB13-00088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'Dexmedetomidine in addition to 15 µg/kg of fentanyl', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal saline as a placebo in addition to 15 µg/kg of fentanyl', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['normal saline'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aymen N Naguib', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Pediatric Cardiothoracic Anesthesia', 'investigatorFullName': 'Aymen N Naguib', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}