Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT03044366
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2016-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
General Anesthesia Management in 15 Preterm Infant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the management of airway', 'timeFrame': 'up to 2 years', 'description': 'the management of airway'}, {'measure': 'gestational age', 'timeFrame': 'up to 2 years', 'description': 'gestational age'}, {'measure': 'American Society of Anesthesiologists physical status scores', 'timeFrame': 'up to 2 years', 'description': 'American Society of Anesthesiologists physical status scores'}, {'measure': 'post-conceptual age', 'timeFrame': 'up to 2 years', 'description': 'post-conceptual age'}, {'measure': 'weight at birth and surgery', 'timeFrame': 'up to 2 years', 'description': 'weight at birth and surgery'}, {'measure': 'duration of anesthesia and surgery', 'timeFrame': 'up to 2 years', 'description': 'duration of anesthesia and surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia Management of Premature Infants']}, 'descriptionModule': {'briefSummary': 'Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of rudimentary build, many medical and physical problems have shown in treatment of disease such as complications, airway problems, temperature disregulation and deficient drug metabolism. This retrospective study evaluates the perioperative management and postoperative course in premature infants undergoing diode laser photocoagulation (DLP) for retinopathy of prematurity (ROP).', 'detailedDescription': 'Participants retrospectively investigate clinical data and anesthesia process of 15 preterm infant from anesthesia charts with ROP who underwent DLP between 2014 and 2016. This presented retrospective study was confirmed by the Institutional Clinical Research Ethics Board. Neonates burns under 30 weeks gestation and low birth weigh under 2000 g were admitted to the study. No infant were excluded from the study. Preterm infants were appreciated before surgery and informed consent was obtained form their parents. We recorded gestational age, American Society of Anesthesiologists (ASA) physical status scores, post-conceptual age, weight at birth and surgery, duration of anesthesia and surgery, blood glucose values at surgery, the management of airway, total hospital stay period, analgesia management, complications and comorbidities. Bradycardia ( \\<90 beats/mean), desaturation (SpO2 \\<90%) and arrhythmia were recorded. Electrocardiography (ECG), pulse oximetric saturation (SpO2), end-tidal carbon dioxide pressure, heart rate (HR) and body temperature were monitored in operating room. Topical 0.5% proparacaine eye drops were administered to all infants routinely. Anesthesia was induced with thiopental 6 mg kg-1 and fentanyl 1 µg kg-1 and it was maintained with 50% oxygen 50% air 1%-3% sevoflurane in all cases. Inhaled anesthetic agent was not preferred for induction of anesthesia because of causing hypotension. The premature infants were intubated by same experienced anesthesiologist. In all infants, were intubated the patients without muscle relaxant under spontaneous ventilation. Perioperative complications, blood glucose value, devices in airway management and extubation value were recorded. After surgery, extubation was performed when spontanea ventilation was enough and extubation was recorded. All infants were taken to newborn intensive care unit (NICU). Data are reported as mean ± standard deviation and percentage(%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patiens who were operated about retinopathy of premature.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all preterm infants who was decided to apply ROP\n\nExclusion Criteria:\n\n* No patient was excluded'}, 'identificationModule': {'nctId': 'NCT03044366', 'briefTitle': 'General Anesthesia Management in 15 Preterm Infant', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'General Anesthesia Management in 15 Preterm Infant Undergoing Diode Laser Photocoagulation for Retinopathy of Prematurity: A Retrospective Study', 'orgStudyIdInfo': {'id': 'ASOZKAN-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Characteristics of Anesthesia management', 'description': 'Evaluate the average value of these data.', 'interventionNames': ['Other: general anesthesia management of preterm infants']}, {'label': 'Comorbidities', 'description': 'Evaluate the average value of these data.', 'interventionNames': ['Other: general anesthesia management of preterm infants']}], 'interventions': [{'name': 'general anesthesia management of preterm infants', 'type': 'OTHER', 'description': 'general anesthesia management of preterm infants', 'armGroupLabels': ['Characteristics of Anesthesia management', 'Comorbidities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44090', 'city': 'Malatya', 'state': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu University Medical Faculty', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Ahmet Selim Ozkan', 'investigatorAffiliation': 'Inonu University'}}}}