Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-28 @ 4:56 AM
Study NCT ID:
NCT00859092
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2009-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elimination of symptoms associated with immature swallowing', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': 'Promotes transition to discharge from hospital', 'timeFrame': 'one week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Swallowing Dysfunction']}, 'descriptionModule': {'briefSummary': 'Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing.\n\nHypotheses:\n\n* Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds\n* Thickened feeds will promote transition to hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. apneas and bradycardias with oral feedings\n2. oxygen desaturations with oral feedings\n3. excessive coughing or gagging with oral feedings\n\nExclusion Criteria:\n\n1. less than 32 weeks adjusted gestational age\n2. greater than 40 weeks adjusted gestational age'}, 'identificationModule': {'nctId': 'NCT00859092', 'briefTitle': 'Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties', 'orgStudyIdInfo': {'id': '07-12-FB-0305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thickening of feeds', 'interventionNames': ['Dietary Supplement: Simply Thick']}, {'type': 'NO_INTERVENTION', 'label': 'Removal of thickener'}], 'interventions': [{'name': 'Simply Thick', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Simply Thick®'], 'description': 'Simply Thick® added to each bottle of formula or beast milk to create nectar or honey consistency', 'armGroupLabels': ['Thickening of feeds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23501', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'David Oelberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of The King's Daughters"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Oelberg, M.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Oelberg, M.D.', 'investigatorAffiliation': 'Eastern Virginia Medical School'}}}}