Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 1:19 PM
Study NCT ID:
NCT04531566
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2020-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours', 'timeFrame': '2 months after enrollment', 'description': 'Measured in the electronic medical record'}], 'secondaryOutcomes': [{'measure': 'PMA at hospital discharge', 'timeFrame': 'up to 6 months after admission'}, {'measure': 'PMA at completion of first oral feed', 'timeFrame': '1 month after enrollment.'}, {'measure': 'length of hospitalization', 'timeFrame': 'up to 6 months after admission'}, {'measure': 'number of gastrostomy tube', 'timeFrame': 'up to 6 months after admission'}, {'measure': 'oxygen at discharge', 'timeFrame': 'up to 6 months after admission'}, {'measure': 'safety outcomes during the feed as measured by the number of desaturations', 'timeFrame': '2 months after enrollment'}, {'measure': 'safety outcomes during the feed as measured by the number of apnea episodes', 'timeFrame': '2 months after enrollment'}, {'measure': 'safety outcomes during the feed as measured by the number of bradycardia episodes', 'timeFrame': '2 months after enrollment'}, {'measure': 'safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed', 'timeFrame': '2 months after enrollment'}, {'measure': 'safety outcomes as measured by the increase in flow after feed', 'timeFrame': '2 months after enrollment'}, {'measure': 'safety outcomes as measured by the number of choking episodes', 'timeFrame': '2 months after enrollment'}, {'measure': 'safety outcomes as measured by the number of episodes of aspiration pneumonia', 'timeFrame': '2 months after enrollment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prematurity', 'Oral Skills', 'Nasal CPAP oral feeds', 'HFNC oral feeds'], 'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (HFNC)/Continuous positive airway pressure (CPAP) to orally feed if demonstrating oral cues will achieve full oral feeds faster.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '32 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants that require greater than 2 litres per minute (LPM) high flow nasal canula or CPAP with a max setting of 6cm H20 FiO2 30% or less for at least 72 hours or more\n* Tolerating enteral feeds of 120 ml/kg/day\n\nExclusion Criteria:\n\n* Major congenital anomalies (pulmonary malformations, airway malformations, craniofacial defects, major congenital heart disease, combined pulmonary intestinal malformations)\n* Metabolic disorder\n* Major gastrointestinal surgeries\n* Patent ductus arteriosus (PDA) ligation surgery\n* Outborn deliveries greater than 7 days old'}, 'identificationModule': {'nctId': 'NCT04531566', 'briefTitle': 'Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support', 'orgStudyIdInfo': {'id': 'HSC-MS-20-0741'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Feed Intervention Group', 'interventionNames': ['Dietary Supplement: Oral Feed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'interventionNames': ['Dietary Supplement: Usual care']}], 'interventions': [{'name': 'Oral Feed', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infant will be seen by occupational therapist (OT) twice a week and assessed for oral cues. If infant shows oral cues then the occupational therapist will proceed with feeding strategies. Oral feeding strategies include pacifier dips, open nipple trials with syringe controlled bolus size (1-4mls) and po trials up to 10mls.', 'armGroupLabels': ['Oral Feed Intervention Group']}, {'name': 'Usual care', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley N Morin, MD', 'role': 'CONTACT', 'email': 'Ashley.N.Morin@uth.tmc.edu', 'phone': '713-500-5800'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Ashley N Morin, MD', 'role': 'CONTACT', 'email': 'Ashley.N.Morin@uth.tmc.edu', 'phone': '(713) 500-5800'}], 'overallOfficials': [{'name': 'Ashley N Morin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow', 'investigatorFullName': 'Ashley N Morin', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}