Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT04013893
Status:
UNKNOWN
Last Update Posted:
2019-07-12
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Enteral Nutrition in Critically Ill Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-d mortality', 'timeFrame': '28 days', 'description': 'To evaluate the effect of enteral feeding timing on survival'}], 'secondaryOutcomes': [{'measure': 'Lactate', 'timeFrame': 'During inotropic treatment', 'description': 'To observe safe lactate levels suitable for enteral nutrition. Lactate levels will be measure 4 times in a day.'}, {'measure': 'Vasoactive inotrope score', 'timeFrame': 'During inotropic treatment', 'description': 'To observe maximum vasoactive inotrope score suitable for enteral nutrition. Maximum VIS will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enteral feeding', 'vasopressor', 'lactate'], 'conditions': ['Critical Illness', 'Enteral Feeding Intolerance']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements.', 'detailedDescription': "The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements. Early enteral nutrition will be initiated within the first 24 hours of hospitalization in critically ill children who have inotropic vasopressor and inodilator support without any problems and contraindications in gastrointestinal system functions. The energy requirement of the intubated patients will be measured by indirect calorie meter method. Schofield method will be used to calculate the daily energy needs of extubated patients. 30% of the targeted energy in the first 48 hours of hospitalization and 80% of the targeted energy in the first week will be achieved by enteral nutrition.Nutritional solutions with a concentrated formula of 1 / 1.5 will be given to patients with cardiac pulmonary or renal disease requiring fluid restriction.Patients will be followed up for vomiting, diarrhea, abdominal distention, feeding intolerance, gastric residues and gastrointestinal bleeding. If these findings develop, the patient's nutrition will be interrupted according to the clinician's assessment and enteral nutrition will be re-fed as soon as possible."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill children who have inotropic, vasopressor or inodilatory supplements without any problems and contraindications in gastrointestinal system functions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with normal gastrointestinal system function\n* Children receiving inotropic, vasopressor or inodilatory support\n\nExclusion Criteria:\n\n* Children with gastrointestinal system dysfunction\n* Children with enteral nutrition contraindicated\n* Children with metabolic disease with special nutrition'}, 'identificationModule': {'nctId': 'NCT04013893', 'briefTitle': 'Evaluation of Enteral Nutrition in Critically Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Evaluation of Enteral Nutrition in Critically Ill Children Receiving Inotropic Support in Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': 'CUTF-GOKAEK-86'}}, 'contactsLocationsModule': {'locations': [{'zip': '01380', 'city': 'Adana', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Dinçer Yildizdaş, Professor', 'role': 'CONTACT', 'email': 'dyildizdas@gmail.com', 'phone': '+903223386060', 'phoneExt': '3377'}], 'facility': 'Cukurova University, Division of Pediatric Intensive Care Unit', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'centralContacts': [{'name': 'Ahmet Yöntem', 'role': 'CONTACT', 'email': 'drayontem@gmail.com', 'phone': '+905075097709'}], 'overallOfficials': [{'name': 'Dincer Yildizdaş, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cukurova University Medicine Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmet Yontem', 'investigatorAffiliation': 'Cukurova University'}}}}