Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 2:07 AM
Study NCT ID:
NCT03981133
Status:
UNKNOWN
Last Update Posted:
2019-06-10
First Post:
2019-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1010}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-07', 'studyFirstSubmitDate': '2019-06-06', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of exclusive breastfeeding', 'timeFrame': 'up to 24 weeks', 'description': 'To compare the prevalence of exclusive breastfeeding at three, four and six months in infants between groups randomized to unrestricted pacifier group and restricted pacifier group'}], 'secondaryOutcomes': [{'measure': 'infant feeding - breastfeeding duration', 'timeFrame': 'up to 24 weeks', 'description': 'to evaluate the duration of exclusive and any breastfeeding duration in months between the two groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pacifier', 'breastfeeding', 'sudden unexpected infant death'], 'conditions': ['Lactation']}, 'descriptionModule': {'briefSummary': 'We will enroll 1010 mother-infant dyads in a randomized trial exploring the effect of distribution of the pacifier during the first days of life on breastfeeding prevalence and duration. .', 'detailedDescription': 'Given the scarcity of scientifically rigorous studies that address the impact of unrestricted pacifier exposure on breastfeeding we plan to conduct a multicenter, randomized, single blind, active control, parallel assignment, efficacy study to assess the impact of offering a pacifier on breastfeeding during the first days of life our hypothesis is that the introduction of a pacifier during the first days of life does not interfere with lactation\n\nA research assistant will approach all eligible mothers during the first 6 hours after birth and will invite them to be randomized to one of the two groups:\n\nUnrestricted pacifier ( the pacifiers can be offered liberally to infants to suck on during their stay at the facility providing maternity and newborn services) and Restricted pacifier group: ( avoid pacifier use until breastfeeding is well established) Women will be followed up at 1, 3, 4, ,6, 8, and 12 months after birth or until breastfeeding ended by a research assistant blinded to the group assignment. Interviews will be conducted by telephone using structured questionnaires designed to assess breastfeeding (exclusive or partial) prevalence and duration, and whether or not the baby had rejected a pacifier the night before the telephone interview. Rates of exclusive, partial, and any other occasional random breastfeeding will be tracked at all these time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '6 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Understands the benefits and risk for offer liberally the pacifier during their stay at the maternity.\n* Expressed an intention to breast feed exclusively their infant for at least 3 -months\n* Possibility of contact by telephone\n* Has the decision to offer a pacifier to the newborn infant , but not definite opinion about when are going to offer a pacifier\n* Primiparous single birth\n* Mother´s age 18 years or more\n\nExclusion Criteria:\n\n* Maternal risk factors for lactation\n\n * Lack of noticeable breast enlargement during pregnancy\n * Flat or inverted nipples\n * Variation in breast appearance (marked asymmetry, hypoplastic, tubular)\n * Any previous breast surgery, including plastics procedure\n* Psychosocial problems (eg, depression, poor or negative support of breastfeeding\n* Mother with a chronic condition that could influence development , including feeding ability\n* Mother with eating or mental disorder.\n* Mothers who smoke during pregnancy'}, 'identificationModule': {'nctId': 'NCT03981133', 'briefTitle': 'Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal'}, 'officialTitle': 'The Missing Answer: When is it Safe to Introduce the Pacifier to the Breastfed Baby? A Multicenter, Randomized, Control Trial', 'orgStudyIdInfo': {'id': 'marita909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: unrestricted pacifier', 'description': 'recommendation to offer a pacifier at the facility providing maternity and newborn services the first days of life', 'interventionNames': ['Behavioral: offer a pacifier']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'restricted pacifierr', 'description': 'recommendation not to offer a pacifier to normal new born infant at the maternity thre first days of live', 'interventionNames': ['Behavioral: no pacifier']}], 'interventions': [{'name': 'offer a pacifier', 'type': 'BEHAVIORAL', 'description': 'offer a pacifier to normal newborn infants the first days of life', 'armGroupLabels': ['A: unrestricted pacifier']}, {'name': 'no pacifier', 'type': 'BEHAVIORAL', 'description': 'not to offer a pacifier at 15 days of life', 'armGroupLabels': ['restricted pacifierr']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bahía Blanca', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Privado de del Sur', 'geoPoint': {'lat': -38.7176, 'lon': -62.26545}}, {'zip': '1199ABB', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de buenos Aires'}, {'zip': '1425', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanatorio de la Trinidad'}, {'zip': '1636', 'city': 'Olivos', 'state': 'Buenos Aires', 'country': 'Argentina', 'contacts': [{'name': 'Alejandro G Jenik, M.D.', 'role': 'CONTACT', 'email': 'alejandro.jenik@hiba.org.ar', 'phone': '5491144061380'}, {'name': 'Alejandro G Jenik, M.D', 'role': 'CONTACT', 'phone': '5491144061389'}, {'name': 'Gonzalo L Mariani, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nestor Vain, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Alejandro Jenik', 'geoPoint': {'lat': -34.50872, 'lon': -58.48026}}, {'city': 'San Isidro', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"t', 'geoPoint': {'lat': -34.46971, 'lon': -58.52111}}, {'zip': 'B1702', 'city': 'San Justo', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro Agustin Rocca HIBA', 'geoPoint': {'lat': -34.68107, 'lon': -58.56379}}], 'centralContacts': [{'name': 'Alejandro G Jenik', 'role': 'CONTACT', 'email': 'alejandro.jenik@hiba.org.ar', 'phone': '5491144061380'}], 'overallOfficials': [{'name': 'alejandro G Jenik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion para el Estudio y la Prevencion de la Muerte Infantil y Perinatal'}, {'name': 'Aleajndro G Jenik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion para erl Estudio y Prevencionde la Muerte Subita y Perinatal'}]}, 'ipdSharingStatementModule': {'url': 'http://sids.org.ar', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'data will be available within 6 months of study', 'ipdSharing': 'YES', 'description': 'weight,gestational age,mother age, vaginal, cesarean,bedsharing, contact skin to skin', 'accessCriteria': 'data access requests will be reviewed by an external independent review panel. Requestors will be required to sifn a Data Access Agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, {'name': 'Fundacion para la Salud Materno Infantil', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor consultant pediatrics', 'investigatorFullName': 'Alejandro Jenik', 'investigatorAffiliation': 'Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal'}}}}