Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT04483492
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Effect of Caffeine on Diaphragmatic Muscles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C026189', 'term': 'caffeine citrate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diphragmatic contractility', 'timeFrame': '30 minutes', 'description': 'diphragmatic contractility measured by ultrasonographic evaluation'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caffeine']}, 'referencesModule': {'references': [{'pmid': '25982138', 'type': 'BACKGROUND', 'citation': 'Kraaijenga JV, Hutten GJ, de Jongh FH, van Kaam AH. The Effect of Caffeine on Diaphragmatic Activity and Tidal Volume in Preterm Infants. J Pediatr. 2015 Jul;167(1):70-5. doi: 10.1016/j.jpeds.2015.04.040. Epub 2015 May 15.'}, {'pmid': '39140727', 'type': 'DERIVED', 'citation': 'Kayki G, Celik HT, Ayaz E, Tandircioglu UA, Oguz B, Yigit S, Yurdakok M. Direct Effect of Caffeine on Diaphragmatic Muscles in Preterm Babies Through Ultrasonographic Examination. Turk Arch Pediatr. 2024 Apr 5;59(3):277-282. doi: 10.5152/TurkArchPediatr.2024.23290.'}]}, 'descriptionModule': {'briefSummary': 'The mechanism of methylxanthines is thought to increase chemoreceptor responsiveness to CO2 in central nervous system. Besides, effect of methylxanthines on diaphragmatic contractility has also been found in experimental studies. A study of premature newborns has showed caffeine increase diaphragmatic activity and tidal volume. But, there is limited data about caffeine direct effect on diaphragma.\n\nObjective: The investigators aimed to show the direct effect of caffeine on diphragmatic contractility.\n\nMethod: The babies under 32 weeks with respiratory support, are being enrolled in this study if caffeine treatment is decided to receive. Evaluation of muscle contraction is being made by ultrasound before and 30 minutes after caffeine loading dose. Right and left sides of diaphragm thickness are being measured by two clinicians on B mode ultrasound by anterior subcostal view. The velocity before and after caffeine administration will be calculated, dividing excursion frequency (parameter) for inspiratory time. Movement of the diaphragm at inspiratory and expiratory phases are also observed on M mode and the difference between the two phases are measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'newborns under 32 weeks with respiratory support on their first week', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newborns under 32 weeks with respiratory support\n* caffeine is decided to give\n\nExclusion Criteria:\n\n* babies with congenital malformations'}, 'identificationModule': {'nctId': 'NCT04483492', 'briefTitle': 'Direct Effect of Caffeine on Diaphragmatic Muscles', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Direct Effect of Caffeine on Diaphragmatic Muscles', 'orgStudyIdInfo': {'id': 'KA-20029'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'newborns under 32 weeks with respiratory support if they are decided to start caffeine treatment', 'interventionNames': ['Drug: Caffeine citrate']}], 'interventions': [{'name': 'Caffeine citrate', 'type': 'DRUG', 'description': 'diaphragm contractility after administration', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hasan Tolga Celik, MD', 'role': 'CONTACT', 'email': 'htcelik@gmail.com', 'phone': '+905305925584'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Hasan Tolga Celik, MD', 'role': 'CONTACT', 'email': 'htcelik@gmail.com', 'phone': '+905305925584'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'H. Tolga Çelik', 'investigatorAffiliation': 'Hacettepe University'}}}}