Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-01 @ 8:34 PM
Study NCT ID:
NCT00427635
Status:
COMPLETED
Last Update Posted:
2010-12-20
First Post:
2007-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia Neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deafness Neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Retinopathy Of Prematurity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neonatal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary Tract Infection Neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oxygen Saturation Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Bradycardia Neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Inappropriate Device Signal Detection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Infantile Apnoeic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.01', 'spread': '77.70', 'groupId': 'OG000'}, {'value': '-24.79', 'spread': '44.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.', 'unitOfMeasure': 'Mean Number of Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.79', 'spread': '40.37', 'groupId': 'OG000'}, {'value': '-13.49', 'spread': '32.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.', 'unitOfMeasure': 'Mean Number of Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.55', 'spread': '49.58', 'groupId': 'OG000'}, {'value': '6.27', 'spread': '28.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes based on 24-hour impedance monitoring data', 'unitOfMeasure': 'Mean Number of Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Acidic Reflux Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.75', 'spread': '32.38', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '18.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes (pH\\<4.0) based on 24-hour impedance monitoring data', 'unitOfMeasure': 'Mean Number of Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Weakly Acidic Reflux Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.60', 'spread': '45.17', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '21.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data', 'unitOfMeasure': 'Mean Number of Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Non Acidic Reflux Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes (pH\\>=7.0) based on 24-hour impedance monitoring data', 'unitOfMeasure': 'Mean Number of Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Liquid Acidic Reflux Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.00', 'spread': '52.03', 'groupId': 'OG000'}, {'value': '3.05', 'spread': '31.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes based on 24-hour impedance monitoring data', 'unitOfMeasure': 'Mean Number of Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.45', 'spread': '17.44', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '13.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes based on 24-hour impedance monitoring data', 'unitOfMeasure': 'Mean Number of Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Bolus Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'spread': '24.56', 'groupId': 'OG000'}, {'value': '-4.05', 'spread': '25.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Based on 24-hour impedance monitoring data', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Acid Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.93', 'spread': '64.32', 'groupId': 'OG000'}, {'value': '-6.36', 'spread': '45.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Based on 24-hour impedance monitoring data', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage Time With pH<4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.73', 'spread': '12.63', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '12.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Percentage time with pH\\<4 during 24-hour pH monitoring', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage Time With pH Within 4.0-6.9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.84', 'spread': '12.64', 'groupId': 'OG000'}, {'value': '-2.60', 'spread': '12.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Percentage time with pH 4.0-6.9 during 24-hour pH monitoring', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}], 'periods': [{'title': 'Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomised', 'groupId': 'FG000', 'numSubjects': '26'}, {'comment': 'Randomised', 'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'ITT population. One voluntary discontinuation by parent/guardian', 'groupId': 'FG000', 'numSubjects': '25'}, {'comment': 'ITT population', 'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Study Completion to Safety Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'comment': 'One participant lost to follow-up', 'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants either full term or those with a gestational age or post-conceptual age ³28 to 44 weeks, and who were inpatients suspected of having the following clinical findings: any 2 (either individually or in any combination) of (1) apnea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Esomeprazole', 'description': 'Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '30.3', 'groupId': 'BG000'}, {'value': '46.5', 'spread': '31.2', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '30.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2007-01-25', 'resultsFirstSubmitDate': '2010-04-19', 'studyFirstSubmitQcDate': '2007-01-25', 'lastUpdatePostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-19', 'studyFirstPostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.'}, {'measure': 'Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes based on 24-hour impedance monitoring data'}, {'measure': 'Change From Baseline in Number of Acidic Reflux Episodes', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes (pH\\<4.0) based on 24-hour impedance monitoring data'}, {'measure': 'Change From Baseline in Number of Weakly Acidic Reflux Episodes', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data'}, {'measure': 'Change From Baseline in Number of Non Acidic Reflux Episodes', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes (pH\\>=7.0) based on 24-hour impedance monitoring data'}, {'measure': 'Change From Baseline in Number of Liquid Acidic Reflux Episodes', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes based on 24-hour impedance monitoring data'}, {'measure': 'Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Number of reflux episodes based on 24-hour impedance monitoring data'}, {'measure': 'Change From Baseline in Mean Bolus Clearance Time', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Based on 24-hour impedance monitoring data'}, {'measure': 'Change From Baseline in Mean Acid Clearance Time', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Based on 24-hour impedance monitoring data'}, {'measure': 'Change From Baseline in Percentage Time With pH<4.0', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Percentage time with pH\\<4 during 24-hour pH monitoring'}, {'measure': 'Change From Baseline in Percentage Time With pH Within 4.0-6.9', 'timeFrame': 'Baseline and end of treatment (10-14 days)', 'description': 'Percentage time with pH 4.0-6.9 during 24-hour pH monitoring'}]}, 'conditionsModule': {'keywords': ['neonates', 'infants', 'GERD', 'reflux'], 'conditions': ['GERD']}, 'referencesModule': {'references': [{'pmid': '23800403', 'type': 'DERIVED', 'citation': 'Davidson G, Wenzl TG, Thomson M, Omari T, Barker P, Lundborg P, Illueca M. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J Pediatr. 2013 Sep;163(3):692-8.e1-2. doi: 10.1016/j.jpeds.2013.05.007. Epub 2013 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-term or gestational age \\>/= 28 to 44 weeks\n* In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent\n* Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization\n\nExclusion Criteria:\n\n* Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract\n* Patients with any condition that may require surgery during the course of the study\n* Patients with acute respiratory distress within 72 hours prior to enrollment'}, 'identificationModule': {'nctId': 'NCT00427635', 'briefTitle': 'Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age', 'orgStudyIdInfo': {'id': 'D9614C00004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'North Adelaide', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -34.90733, 'lon': 138.59141}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Marta Illueca, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Per Lundborg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Kathryn Collison, MPH, MT(ASCP)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}