Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-03 @ 9:32 AM
Study NCT ID:
NCT07149766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Crawling and Breastfeeding Success
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postpartum Comfort Scale', 'timeFrame': 'Within the first 24 hours postpartum', 'description': 'Description: Measures physical, psychological, and environmental comfort after childbirth. (The scale is a 34-item Likert-type scale. The lowest possible score is 34, and the highest is 170. A higher score indicates higher postpartum comfort.)'}, {'measure': 'Postpartum Breastfeeding Self-Efficacy Scale', 'timeFrame': 'At 24 hours postpartum', 'description': "Description: Evaluates the mother's confidence in her ability to breastfeed successfully. The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The scale has no cut-off point, and a higher score indicates higher breastfeeding self-efficacy."}], 'secondaryOutcomes': [{'measure': 'Demographic Information Form', 'timeFrame': 'baseline', 'description': 'Tool: Mother and Infant Demographic Information Form\n\nDescription: Includes maternal age, parity, delivery mode, gestational week, newborn Apgar scores, birth weight, and gender.\n\nPurpose: To identify potential confounding variables and describe the study population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnacy', 'Newborn', 'Breastfeeding']}, 'descriptionModule': {'briefSummary': 'Breast crawling, also referred to as the newborn\'s self-attachment, was first observed in 1977 and described as the "first important sucking behavior". During the first hour after birth, the newborn exhibits instinctive movements aimed at locating and attaching to the breast. In 1987, Swedish researchers Widström et al., and later in 1990, Righard and Alade, detailed these behaviors through systematic observation.\n\nThey found that when a newborn is placed prone on the mother\'s abdomen immediately after birth-while the mother is in a supine position-the baby begins to engage rooting and stepping reflexes. These reflexes typically lead the baby to begin crawling toward the breast around 29 minutes after birth, with effective suckling starting approximately 50 minutes postpartum.This instinctual behavior, observed in the first hour of life when the newborn is most alert and active, has been well documented in the literature as "the breast crawl." It demonstrates the neonate\'s innate capacity to find and latch onto the mother\'s breast using biological reflexes when uninterrupted.\n\nRighard and Alade emphasized that routine hospital practices often interrupt this natural sequence, which may negatively impact the breastfeeding process. They underlined the importance of preserving the immediate postnatal hour, a critical window in which these behaviors are most likely to occur and support early breastfeeding success.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnacy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years of age,\n* Volunteering to participate in the study,\n* Ability to speak, write, and understand Turkish,\n* No communication difficulties,\n* Having had a spontaneous vaginal delivery,\n* Primigravida giving birth for the first time,\n* The baby was given to the mother within the first hour after birth,\n* Having a full-term, singleton, and healthy newborn,\n* No condition preventing breastfeeding in either mother or baby.\n* The baby was born with an APGAR score of 7 or higher,\n* The baby had no tongue, lip, or mouth anomalies,\n* Coordination of sucking, rooting, and swallowing was present.\n\nExclusion Criteria:\n\n* The mother did not want to participate in the study or wished to terminate the study,\n* The mother had a postpartum emergency requiring medical intervention.'}, 'identificationModule': {'nctId': 'NCT07149766', 'briefTitle': 'Breast Crawling and Breastfeeding Success', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'Breast Crawling and Breastfeeding Success', 'orgStudyIdInfo': {'id': 'Zehra Tostanoğlu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'interventionNames': ['Other: Breast crawling']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Breast crawling', 'type': 'OTHER', 'description': "The newborn will be placed on the mother's abdomen for no more than 60 minutes, during which breast crawling and suckling behaviors will be observed. Throughout this period, the researcher will maintain active communication with the mother, providing information on the importance of breastfeeding.\n\nThe mother will be gently guided to support the baby when necessary, without interfering with the baby's natural instincts. The newborn's heart rate, respiratory rate, and body temperature will be recorded at birth and at the 60th minute.", 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Öznur Tiryaki, Asoss.Prof.', 'role': 'CONTACT', 'email': 'oznuritiryaki@gmail.com', 'phone': '0264 295 66 17'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'For ethical reasons, patient information may be shared upon reasonable request without revealing their identities for security reasons.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'öznur tiryaki', 'investigatorAffiliation': 'Sakarya University'}}}}