Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01526018
Status:
TERMINATED
Last Update Posted:
2014-08-18
First Post:
2012-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Inadequate recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-14', 'studyFirstSubmitDate': '2012-01-31', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake', 'timeFrame': '2 weeks', 'description': 'Rate of intake, volume of intake, duration of meal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intake', 'Formula feeding'], 'conditions': ['Infant Feeding Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. Once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. It is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Bottle-fed infants aged 1-6 months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy, exclusively formula-fed infants aged 1-6 months at enrollment;\n* parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week.\n\nExclusion Criteria:\n\n* born \\< 37 weeks;\n* birth weight \\< 2500g or \\> 4000g;\n* current weight \\< 10th percentile for age;\n* hospitalization \\> 72 hours following birth or any hospital admission since birth;\n* any health issue that could interfere with feeding and/or growth;\n* use of complementary foods;\n* inability or unwillingness to comply with study-related procedures.'}, 'identificationModule': {'nctId': 'NCT01526018', 'briefTitle': 'The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'orgStudyIdInfo': {'id': 'F110921001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Novel bottle', 'interventionNames': ['Behavioral: Podee bottle']}], 'interventions': [{'name': 'Podee bottle', 'type': 'BEHAVIORAL', 'description': 'Infants will acclimate to the Podee bottle over the course of several weeks. All infants will consume meals from the Podee and their usual bottles.', 'armGroupLabels': ['Novel bottle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Paula Chandler-Laney, PhD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}