Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-24 @ 3:57 AM
Study NCT ID:
NCT03709004
Status:
WITHDRAWN
Last Update Posted:
2019-09-27
First Post:
2018-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041361', 'term': 'Pacifiers'}], 'ancestors': [{'id': 'D015370', 'term': 'Infant Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study was not funded and is not going to be done.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-10-15', 'lastUpdatePostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maternal Stress', 'timeFrame': '2, 4, 6, 12, 18, and 24 weeks', 'description': 'Via Perceived Stress Scale (10 items, 5-point Likert scale)'}, {'measure': 'Infant Feeding Efficiency', 'timeFrame': '2 and 6 weeks', 'description': "Volume of breast milk or formula consumed via bottle within the first three minutes of feeding (mL/min); considered in the context of the infants' state (e.g., alert/awake, drowsy) and nipple size"}], 'primaryOutcomes': [{'measure': 'Infant Feeding - Breastfeeding Status', 'timeFrame': 'up to 24 weeks', 'description': 'Mode of infant feeding: yes or no'}, {'measure': 'Infant Feeding - Breastfeeding Duration', 'timeFrame': 'up to 24 weeks', 'description': 'Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all)'}], 'secondaryOutcomes': [{'measure': 'Pacifier Use', 'timeFrame': '2, 4, and 6 weeks', 'description': 'Any use and frequency in the last 24 hours (7-point Likert scale)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pacifier'], 'conditions': ['Breastfeeding', 'Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'We will enroll 40 mother-infant dyads in a randomized trial exploring the effect of distribution of pacifiers during the birth hospitalization to mothers at high risk for postpartum depression on pacifier use, infant feeding, and maternal stress.', 'detailedDescription': 'This study is a pilot a randomized controlled trial to determine if pacifier distribution affects breastfeeding among mothers at high risk for postpartum depression. We will recruit 40 mothers of healthy singleton births in a U.S. hospital who are at high risk of postpartum depression and randomly assign them to receive a pacifier or not. We will ascertain pacifier use, maternal stress, and infant feeding behaviors with web-based surveys at 2, 4, 6, 12, 18, and 24 weeks. Mothers will also wear a wristband to detect maternal heart rate variability throughout the first 6 weeks as a marker of maternal stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Breastfeeding mother/infant dyad, receiving postpartum care at UC Davis Medical Center, maternal personal or family history of depression or postpartum depression, mother 18-45 years of age, infant 12-72 hours of age\n\nExclusion Criteria:\n\n* infant without congenital anomalies that could affect feeding (cleft lip/palate, chromosomal anomaly, micro or retrognathia), infant preterm (born prior to 37 weeks' gestation), mother unable to participate in English, infant admitted to the neonatal intensive care unit, No smart phone"}, 'identificationModule': {'nctId': 'NCT03709004', 'briefTitle': 'Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Effect of Hospital Pacifier Distribution on Breastfeeding Among Mothers at High Risk for Postpartum Depression', 'orgStudyIdInfo': {'id': '1132743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pacifier', 'description': 'Mother given a pacifier during birth hospitalization, along with other baby items', 'interventionNames': ['Other: Pacifier']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Mother not given a pacifier, just the other baby items'}], 'interventions': [{'name': 'Pacifier', 'type': 'OTHER', 'description': 'Pacifier given to mom.', 'armGroupLabels': ['Pacifier']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Benedictine University', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}