Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT03619369
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circumcision and Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002944', 'term': 'Circumcision, Male'}], 'ancestors': [{'id': 'D046289', 'term': 'Body Modification, Non-Therapeutic'}, {'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding Rates', 'timeFrame': 'From birth thru 6 months of age', 'description': 'Exclusive Breastfeeding Rates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breastfeeding, Exclusive', 'Circumcision']}, 'referencesModule': {'references': [{'pmid': '35574656', 'type': 'DERIVED', 'citation': 'Mondzelewski L, Mu T, Michalski A, Ward J, Cheng L, Chen M, Riffenburgh R, Holmes A. Timing of Circumcision and Breastfeeding Frequency: A Multicenter, Randomized Clinical Trial. Hosp Pediatr. 2022 Jun 1;12(6):555-560. doi: 10.1542/hpeds.2021-006400.'}]}, 'descriptionModule': {'briefSummary': '1\\) To determine when the majority of male infants are being circumcised at 3 hospitals across the US (Brooke Army Medical Center, Naval Medical Center San Diego, and Dartmouth Hitchcock Medical Center. 2) To assess the breastfeeding patterns of circumcised male infants at the above-mentioned academic medical centers. Specifically, to determine if these babies are breastfeeding at the time of hospital discharge, at their newborn visit, their 2-week visit, and all subsequent well visits up until 6 months of age.\n\n3\\) To determine if there is a significant relationship between the timing of newborn circumcision and breastfeeding initiation, establishment, and maintenance in the first 6 months of life. We hypothesize that the timing of circumcision will not be significantly associated with frequency of breastfeeding among mother-infant dyads during the initial months of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All male infants born at the 3 participating sites\n\nExclusion Criteria:\n\n* Gestational age \\<38 weeks, twin/multiple deliveries, NICU admission, mothers who are strictly formula feeding their newborns from the time of delivery, and mothers under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT03619369', 'briefTitle': 'Circumcision and Breastfeeding', 'organization': {'class': 'FED', 'fullName': 'Brooke Army Medical Center'}, 'officialTitle': 'Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'C.2016.112d'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early Circumcision', 'interventionNames': ['Procedure: Circumcision']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Routine Circumcision', 'interventionNames': ['Procedure: Circumcision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Circumcision', 'interventionNames': ['Procedure: Circumcision']}], 'interventions': [{'name': 'Circumcision', 'type': 'PROCEDURE', 'description': 'Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates', 'armGroupLabels': ['Delayed Circumcision', 'Early Circumcision', 'Routine Circumcision']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brooke Army Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'United States Naval Medical Center, San Diego', 'class': 'FED'}, {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist', 'investigatorFullName': 'Thornton Mu', 'investigatorAffiliation': 'Brooke Army Medical Center'}}}}