Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT00560859
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2007-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Childhood Adenotonsillectomy Study for Children With OSAS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012913', 'term': 'Snoring'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000233', 'term': 'Adenoidectomy'}, {'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sellenbe@upenn.edu', 'phone': '215-573-3904', 'title': 'Dr. Susan S. Ellenberg', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Children under 5 years of age, in whom OSAS is common, were not included. Children on medications for ADHD or with prolonged oxygen-hemoglobin desaturation were also excluded, so results cannot be extrapolated to such children.'}}, 'adverseEventsModule': {'timeFrame': 'Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Early AT Surgery', 'description': 'Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.\n\nAdenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.', 'otherNumAtRisk': 226, 'otherNumAffected': 166, 'seriousNumAtRisk': 226, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Watchful Waiting', 'description': 'Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.\n\nWatchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.', 'otherNumAtRisk': 227, 'otherNumAffected': 227, 'seriousNumAtRisk': 227, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenoviral upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergy to sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthmatic crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Attention Deficit/Hyperactivitiy disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Glucose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Body Tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breath Odor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Choking sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjuctivits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup Non infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes Mellitus non-insulin dependent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Infection Baceterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Piercing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Tube removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'electroencephalogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency care examination normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'External ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever (in the absence of neutropenia, where neutropenia is defined as anc <1.0 x 10e9/l)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Finger nail removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis adenovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'genital rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Growing pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'infected insect bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'infection with unknown anc - bladder (urinary)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lice infestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'multiple allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nail Tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nasal cavity/paranasal sinus reactions', 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'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early AT Surgery', 'description': 'Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.\n\nAdenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.'}, {'id': 'OG001', 'title': 'Watchful Waiting', 'description': 'Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.\n\nWatchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of change from baseline', 'paramValue': '2.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'The primary endpoint measure will occur at 7 months following the baseline visit.', 'description': 'The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early AT Surgery', 'description': 'Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.\n\nAdenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.'}, {'id': 'OG001', 'title': 'Watchful Waiting', 'description': 'Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.\n\nWatchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-7.1', 'upperLimit': '-1.8'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '7 months following the baseline visit.', 'description': 'The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.', 'unitOfMeasure': 'Events per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early AT Surgery', 'description': 'Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.\n\nAdenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.'}, {'id': 'OG001', 'title': 'Watchful Waiting', 'description': 'Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.\n\nWatchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 months following baseline.', 'description': 'Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There was missing data for some children in the Watchful Waiting group since the Pediatric Sleep Questionnaire was not completed. Hence these numbers are not consistent with the rows in the participant flow module'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early AT Surgery', 'description': 'Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.\n\nAdenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.'}, {'id': 'FG001', 'title': 'Watchful Waiting', 'description': 'Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a\n\nWatchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '227'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}], 'recruitmentDetails': 'Children were recruited at 7 academic sleep centers. Early in the trial the investigator at one center relocated and that center was withdrawn.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early AT Surgery', 'description': 'Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.\n\nAdenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.'}, {'id': 'BG001', 'title': 'Watchful Waiting', 'description': 'Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.\n\nWatchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '453', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'These numbers represent all children randomized .'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2007-11-19', 'resultsFirstSubmitDate': '2015-07-13', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-10', 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.', 'timeFrame': 'The primary endpoint measure will occur at 7 months following the baseline visit.', 'description': 'The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.'}], 'secondaryOutcomes': [{'measure': 'Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months', 'timeFrame': '7 months following the baseline visit.', 'description': 'The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.'}, {'measure': 'Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale', 'timeFrame': '7 months following baseline.', 'description': 'Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep disordered breathing', 'Sleep apnea', 'Tonsillectomy', 'Adenoidectomy', 'Snoring', 'Neurobehavioral Manifestations', 'Obstructive Sleep Apnea Syndrome'], 'conditions': ['Obstructive Sleep Apnea', 'Snoring']}, 'referencesModule': {'references': [{'pmid': '40720163', 'type': 'DERIVED', 'citation': 'Tsou PY, Alex RM, Redline S, Sands SA. Pathophysiological Traits in Pediatric Obstructive Sleep Apnea. 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Quality of life and obstructive sleep apnea symptoms after pediatric adenotonsillectomy. Pediatrics. 2015 Feb;135(2):e477-86. doi: 10.1542/peds.2014-0620. Epub 2015 Jan 19.'}, {'pmid': '25474490', 'type': 'DERIVED', 'citation': 'Mitchell RB, Garetz S, Moore RH, Rosen CL, Marcus CL, Katz ES, Arens R, Chervin RD, Paruthi S, Amin R, Elden L, Ellenberg SS, Redline S. The use of clinical parameters to predict obstructive sleep apnea syndrome severity in children: the Childhood Adenotonsillectomy (CHAT) study randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2015 Feb;141(2):130-6. doi: 10.1001/jamaoto.2014.3049.'}, {'pmid': '25070302', 'type': 'DERIVED', 'citation': 'Katz ES, Moore RH, Rosen CL, Mitchell RB, Amin R, Arens R, Muzumdar H, Chervin RD, Marcus CL, Paruthi S, Willging P, Redline S. Growth after adenotonsillectomy for obstructive sleep apnea: an RCT. Pediatrics. 2014 Aug;134(2):282-9. doi: 10.1542/peds.2014-0591.'}, {'pmid': '24497655', 'type': 'DERIVED', 'citation': 'Weinstock TG, Rosen CL, Marcus CL, Garetz S, Mitchell RB, Amin R, Paruthi S, Katz E, Arens R, Weng J, Ross K, Chervin RD, Ellenberg S, Wang R, Redline S. Predictors of obstructive sleep apnea severity in adenotonsillectomy candidates. Sleep. 2014 Feb 1;37(2):261-9. doi: 10.5665/sleep.3394.'}, {'pmid': '23692173', 'type': 'DERIVED', 'citation': 'Marcus CL, Moore RH, Rosen CL, Giordani B, Garetz SL, Taylor HG, Mitchell RB, Amin R, Katz ES, Arens R, Paruthi S, Muzumdar H, Gozal D, Thomas NH, Ware J, Beebe D, Snyder K, Elden L, Sprecher RC, Willging P, Jones D, Bent JP, Hoban T, Chervin RD, Ellenberg SS, Redline S; Childhood Adenotonsillectomy Trial (CHAT). A randomized trial of adenotonsillectomy for childhood sleep apnea. N Engl J Med. 2013 Jun 20;368(25):2366-76. doi: 10.1056/NEJMoa1215881. Epub 2013 May 21.'}], 'seeAlsoLinks': [{'url': 'http://www.nhlbi.nih.gov/about/ncsdr/', 'label': 'National Center on Sleep Disorder Research'}]}, 'descriptionModule': {'briefSummary': "The purpose of this research is to determine the effect of adenotonsillectomy surgery (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children. OSAS can cause health problems including poor growth, high blood pressure, diabetes and behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve afterwards. This study will help determine if improvement occurs or if it does not. It will also look at whether certain groups, such as children who are overweight or of different ethnicities, are helped by the surgery.", 'detailedDescription': 'Because adenotonsillectomy is the usual treatment for OSAS, all children in the study will get surgery. However, in order to assess the extent to which adenotonsillectomy surgery improves breathing disturbances and sleep quality in children with OSAS, two groups will be studied. One group will get surgery early (one month after enrollment) and the other group will be re-evaluated for surgery within 7 months of enrollment.\n\nChildren in both groups will be closely monitored through the 7-8 month study period and sleep and health educational materials will be provided to assist in establishing healthy habits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ages 5.0 to 9.99 years at time of screening.\n2. Diagnosed with Obstructive Sleep Apnea defined as: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 2, confirmed on nocturnal, laboratory-based PSG and Parental report of habitual snoring (on average occurring \\>3 nights per week).\n3. Tonsillar hypertrophy ≥ 1 based on a standardized scale of 0-4: 0 = surgically absent, 1 = taking up \\< 25% of the airway, 2 = 25 - 50 % of the airway,3 = 50 - 75 % of the airway, 4 = \\> 75% of the airway\n4. Deemed to be a surgical candidate for AT by Ear, Nose and Throat specialist (ENT) evaluation.\n\nExclusion Criteria:\n\n1. Recurrent tonsillitis defined as: \\>3 episodes in each of 3 years, 5 episodes in each of 2 years, or 7 episodes in one year\n2. Craniofacial anomalies, including cleft lip and palate or sub-mucosal cleft palate or any anatomic or systemic condition which would interfere with general anesthesia or removal of tonsils and adenoid tissue in the standard fashion\n3. Obstructive breathing while awake that merits prompt AT in the opinion of the child's physician\n4. Severe OSAS or significant hypoxemia requiring immediate AT as defined by: OAI\\>20 or AHI\\>30, desaturation defined as oxygen saturation (SaO2) \\<90% for more than 2% sleep time\n5. Apnea hypopnea indices in the normal range (OAI \\< 1 and AHI \\<2)\n6. Evidence of clinically significant cardiac arrhythmia on PSG: Non-sustained ventricular tachycardia Atrial fibrillation, Second degree atrioventricular (AV) block: Sustained bradycardia \\< 40 bpm (\\> 2 minutes, Sustained tachycardia \\> 140 bpm (\\> 2 minutes)\n7. Extremely overweight defined as: body mass index \\> 2.99 age group and sex-z-score\n8. Severe health problems that could be exacerbated by delayed treatment for OSAS Including: Doctor-diagnosed heart disease or cor pulmonale, history of Stage II Hypertension (HTN) defined as \\> 99% percentile plus 5 mmHg for either systolic or diastolic, based on the age, gender, and height and/or requiring medication, therapy for failure to thrive or short stature, psychiatric or behavioral disorders requiring or likely to require initiation of new medication, therapy, or other specific treatment. School aged children, parental report of excessive daytime sleepiness defined as unable to maintain wakefulness, at least three times per week, in routine activities in school or home, despite adequate opportunity to sleep.\n9. Severe chronic health conditions that might hamper participation including: severe cardiopulmonary disorders, sickle cell anemia, poorly controlled asthma, epilepsy requiring medication, diabetes (type I or type II) requiring medication, conditions likely to preclude accurate polysomnography (e.g. severe uncontrolled pain),mental retardation or enrollment in a formal school Individual Educational Plan (IEP) and assigned to a self-contained classroom for all academic subjects, history of inability to complete cognitive testing and/or score on the Differential Ability Scale (DAS) II of ≤ 55, chronic infection or HIV\n10. Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition, or behavior\n11. Current use of one or more of the following medications: psychotropics, hypnotics,hypoglycemic agents or insulin,antihypertensives,growth hormone, anticonvulsants,anti-coagulants,daily oral corticosteroids, daily medications for pain\n12. Previous upper airway surgery on the nose, pharynx or larynx, including tonsillectomy. Ear surgery and/or pressure equalizing (PE) tubes are not exclusion criteria\n13. Receives Continuous Positive Airway Pressure (CPAP) treatment\n14. A parent or guardian who cannot accompany the child on the night of polysomnogram (PSG)\n15. A family planning to move out of the area within the year\n16. Female participants only: Parental report that child has reached menarche"}, 'identificationModule': {'nctId': 'NCT00560859', 'acronym': 'CHAT', 'briefTitle': 'Childhood Adenotonsillectomy Study for Children With OSAS', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': '804695'}, 'secondaryIdInfos': [{'id': '5U01HL083129-05', 'link': 'https://reporter.nih.gov/quickSearch/5U01HL083129-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early AT Surgery', 'description': 'There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit.', 'interventionNames': ['Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils']}, {'type': 'OTHER', 'label': 'Watchful Waiting', 'description': 'Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.', 'interventionNames': ['Other: Watchful Waiting']}], 'interventions': [{'name': 'Adenotonsillectomy (AT) - removal of adenoids and tonsils', 'type': 'PROCEDURE', 'otherNames': ['EAT'], 'description': 'Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils', 'armGroupLabels': ['Early AT Surgery']}, {'name': 'Watchful Waiting', 'type': 'OTHER', 'otherNames': ['Watchful Waiting with Supportive Care (WWSC)'], 'description': 'Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.', 'armGroupLabels': ['Watchful Waiting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Cardinal Glennon Children's Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Montefiore Children's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Rainbow Babies & Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19401', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Susan Redline, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard University'}, {'name': 'Susan Ellenberg, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Ron Chervin, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Bruno Giordani, PH.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univeristy of Michigan'}, {'name': 'Susan Garetz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Michigan'}, {'name': 'Raouf Amin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Cincinnati Children's Hopsital Medical Center (CCHMC)"}, {'name': 'Carole Marcus, MBB Ch.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}, {'name': 'Carol Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Case University School of Medicine; Rainbow Babies & Children's Hospital"}, {'name': 'Ron Mitchell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Cardinal Glennon Children's Medical Center, St. Louis MO"}, {'name': 'Raanan Arens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Montefiore Children's Hospital Albert Einstein Med Ctr, NY NY"}, {'name': 'Hiren Muzumdar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Montefiore Chilren's Hospital Albert Einstein Med Ctr, NY NY"}, {'name': 'Eliot Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital, Boston MA"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard University', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}