Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-04-09 @ 4:49 PM
Study NCT ID:
NCT06246032
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Modified Feeding Protocol on Neonatal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001724', 'term': 'Birth Weight'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-02-03', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Stay (LOS)', 'timeFrame': 'Up to 8 weeks', 'description': 'Number of days that participant stayed at hospital'}, {'measure': 'Duration of Total Parenteral Nutrition (TPN)', 'timeFrame': 'up to 2 weeks', 'description': 'Number of days that participant received Total Parenteral Nutrition (TPN)'}], 'secondaryOutcomes': [{'measure': 'Incidence of Necrotizing Enterocolitis', 'timeFrame': 'Up to 8 weeks', 'description': 'Stage 2, Stage 3'}, {'measure': 'Incidence of Feeding intolerance', 'timeFrame': 'Up to 8 weeks', 'description': 'abdominal grith more than 2 cm, gastric residual 50% of the last feed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feeding protocol', 'Neonates', 'Preterm', 'Very low birthweight', 'NICU'], 'conditions': ['Preterm', 'Birth Weight', 'Feeding Disorder Neonatal']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg.\n\nThe main questions it aims to answer are:\n\n* Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay?\n* Is Modified feeding protocol feasible, efficient, and safe in preterm infants?\n\nParticipants will undergo the modified feeding protocol since birth until discharge.', 'detailedDescription': 'two group in this study Prospective group: intervention group will undergo the modified feeding protocol Retrospective group: intervention group will undergo the current feeding protocol\n\nBoth group will have care as routine care to this kind of patients But the differ will be in feeding protocol as initiation rate, advancement rate, human milk fortification rate\n\nThe outcomes of both group will be compeered to meet the study objectives'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight (\\<2000g)\n* Gestational Age (\\<37 week)\n\nExclusion Criteria:\n\n* Metabolic Disorders\n* Congenital Heart Diseases\n* Chronic Lung Disease\n* Congenital Anomalies (can related to feeding)\n* Moderate to severe GERD\n* Necrotizing enterocolitis stage 3 (surgical)\n* Gastrointestinal surgery'}, 'identificationModule': {'nctId': 'NCT06246032', 'briefTitle': 'Impact of Modified Feeding Protocol on Neonatal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'Impact of Modified Feeding Protocol on Neonatal Outcomes', 'orgStudyIdInfo': {'id': 'IRB-PGS-2023-03-443'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified feeding Protocol', 'description': 'Prospective', 'interventionNames': ['Other: Modified feeding Protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Current feeding Protocol', 'description': 'Retrospective data will be collected from medical record of patients undergo the current feeding protocol as follow\n\nInitiation of feeding (average):\n\n8.7cc/kg (6-12cc/kg)\n\nAdvancement based on birthweight (average):\n\n\\<750g: 20cc/kg/d (17-24cc/kg/d) 750-999g: 29cc/kg/d (25-34cc/kg/d) 1000-1249g: 22cc/kg/d (20-24cc/kg/d) 1250-1499g: 24cc/kg/d (21-25cc/kg/d) 1500-1749g: 20cc/kg/d (18-21cc/kg/d) 1750-2000g: 34cc/kg/d (32-36cc/kg/d)\n\nStarting Human milk fortification when feed reach at 120cc/kg/d'}], 'interventions': [{'name': 'Modified feeding Protocol', 'type': 'OTHER', 'description': 'Initiation of feeding (fixed): 10cc/kg\n\nAdvancement based on birthweight (fixed):\n\n\\<750g: 15cc/kg/d 750-999g: 20cc/kg/d 1000-1249g: 25cc/kg/d 1250-1499g: 25cc/kg/d 1500-1749g: 35cc/kg/d 1750-2000g: 35cc/kg/d\n\nStarting Human milk fortification when feed reach at 70cc/kg/d', 'armGroupLabels': ['Modified feeding Protocol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dammam', 'state': 'Eastern Province', 'country': 'Saudi Arabia', 'facility': 'Maternity and Children Hospital', 'geoPoint': {'lat': 26.43442, 'lon': 50.10326}}], 'overallOfficials': [{'name': 'Hanan AlQahtani, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imam Abdulrahman Bin Faisal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Dietitian', 'investigatorFullName': 'Hanan AlQahtani', 'investigatorAffiliation': 'Imam Abdulrahman Bin Faisal University'}}}}