Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT02016651
Status:
COMPLETED
Last Update Posted:
2013-12-20
First Post:
2013-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positioning and Gastric Aspiration in Ventilated Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063466', 'term': 'Respiratory Aspiration of Gastric Contents'}], 'ancestors': [{'id': 'D057045', 'term': 'Laryngopharyngeal Reflux'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'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'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-16', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pepsin concentration in tracheal aspirate', 'timeFrame': '6 hours after intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Respiratory Aspiration of Gastric Contents']}, 'referencesModule': {'references': [{'pmid': '18245400', 'type': 'BACKGROUND', 'citation': 'Farhath S, He Z, Nakhla T, Saslow J, Soundar S, Camacho J, Stahl G, Shaffer S, Mehta DI, Aghai ZH. Pepsin, a marker of gastric contents, is increased in tracheal aspirates from preterm infants who develop bronchopulmonary dysplasia. Pediatrics. 2008 Feb;121(2):e253-9. doi: 10.1542/peds.2007-0056.'}, {'pmid': '18829800', 'type': 'BACKGROUND', 'citation': 'Aly H, Badawy M, El-Kholy A, Nabil R, Mohamed A. Randomized, controlled trial on tracheal colonization of ventilated infants: can gravity prevent ventilator-associated pneumonia? Pediatrics. 2008 Oct;122(4):770-4. doi: 10.1542/peds.2007-1826.'}]}, 'descriptionModule': {'briefSummary': 'Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific marker for aspiration. The objective of this study is to examine if TA pepsin will change when ventilated premature infants are positioned in two different positions; on their back vs. on their right side.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born between 28 and 32 weeks gestational age\n* postnatal age \\> 72 hours\n* tracheally intubated and receiving conventional mechanical ventilation\n* feeding enterally more than 20 ml per day.\n\nExclusion Criteria:\n\n* neurological insult in the form of perinatal asphyxia (pH \\<7, base deficit more than 12, Apgar score at \\< 3 at 5 minutes of life), intracranial hemorrhage grades 3 or 4 at 72 hours of age or periventricular leucomalacia\n* major congenital anomalies, or gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis ,\n* receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedation'}, 'identificationModule': {'nctId': 'NCT02016651', 'briefTitle': 'Positioning and Gastric Aspiration in Ventilated Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Positioning and Gastric Aspiration in Ventilated Premature Infants', 'orgStudyIdInfo': {'id': '20120101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Right side position', 'description': 'Premature infants on mechanical ventilation are kept on their right side', 'interventionNames': ['Behavioral: Right side position']}, {'type': 'NO_INTERVENTION', 'label': 'Supine position', 'description': 'Premature infants on mechanical ventilation are kept on their back'}], 'interventions': [{'name': 'Right side position', 'type': 'BEHAVIORAL', 'description': 'Enrolled infants are positioned on their back or right side. Tracheal aspirate is assessed for pepsin concentration as an index of aspiration.', 'armGroupLabels': ['Right side position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': "Cairo University Children's Hospital", 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Reem Mahmoud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Cairo University Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Visiting Professor of Pediatrics', 'investigatorFullName': 'Hany Aly', 'investigatorAffiliation': 'Cairo University'}}}}