Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-03-09 @ 7:22 AM
Study NCT ID:
NCT05821569
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'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'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the frontal cerebral cortex functional synchronization in mother-newborn dyads adopting biological nurturing vs standard position to breastfeed', 'timeFrame': 'At the second day after birth', 'description': 'To evaluate by fNIRS hyperscanning if the frontal cerebral cortex functional synchronization of mother-newborn dyads who adopt a reciprocal positioning according to the biological nurturing approach during breastfeeding, differs from that of mother-newborn dyads adopting the standard position. Cortical activation associated with breastfeeding will be assessed by multichannel fNIRS (Hitachi mod. ETG 4000, 48 channels), using a fibre holder in plastic in mothers and in soft material (neoprene) in newborns, with an interfibre distance of 3 cm. Bilateral functional activity in the frontal and somatomotor areas will be monitored in both mother and newborn (24 channels each).'}, {'measure': 'To compare the presence of postpartum depressive symptoms in women adopting biological nurturing vs standard position to breastfeed', 'timeFrame': 'At the second day after birth', 'description': 'The presence of maternal postpartum depressive symptoms will be evaluated by the Edinburgh Postnatal Depression Scale (EPDS), a set of 10 screening questions. Each answer is given a score of 0 to 3. Cut-off values of 10 or higher suggest the presence of depression.'}], 'secondaryOutcomes': [{'measure': 'To compare the oxytocin level of mothers adopting different position during breastfeeding (standard position vs biological nursing)', 'timeFrame': 'At the second day after birth', 'description': 'To evaluate differences in salivary oxytocin levels of mothers adopting the biological nurturing approach to breastfeed vs mothers adopting the standard position. In multivariate analysis also the intensity of maternal postpartum depressive symptoms assessed by EPDS will be take into account. EPDS is a set of 10 screening questions. Each answer is given a score of 0 to 3. Cut-off values of 10 or higher suggest the presence of maternal postpartum depression.'}, {'measure': 'To evaluate the oxytocin level of newborns according to different position adopted during breastfeeding (standard position vs biological nursing)', 'timeFrame': 'At the second day after birth', 'description': 'To evaluate differences in salivary oxytocin levels of newborns breastfed adopting the biological nurturing approach vs newborns breastfed adopting the standard position'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breastfeeding', 'Near-infrared spectroscopy', 'Postpartum depression'], 'conditions': ['Depression, Postpartum']}, 'descriptionModule': {'briefSummary': "Different reciprocal positions of mother and newborn during breastfeeding may be adopted. Other than the one derived from UNICEF guidelines, or standard position, an approach called biological nurturing has been recently proposed. It aims to promote the activation of neonatal primitive reflexes, breast problems reduction (e.g. cracked or sore nipple) and, overall, spontaneity and naturalness of mother-newborn dyad behaviour during feeding.\n\nThe study of newborn cortical activation by functional near-infrared spectroscopy (fNIRS), a safe and minimally invasive functional neuroimaging technique based on haemoglobin absorption of near-infrared light, showed that baby's cortex exhibit a wide activation associated with breastfeeding. Moreover, preliminary and not yet published data, collected by fNIRS hyperscanning (e.g. the simultaneous detection of brain functional activation from two individuals living the same experience) in the Nursery of our Institute, evidenced that mother-newborn dyads adopting a biological nurturing approach to breastfeeding show a neural synchronization between their frontal cortex during such experience. Basing on this new evidence, it is now worth to understand if a biological nurturing approach to breastfeeding may promote such neural synchronization, even when postpartum depressive symptoms are present. Accordingly, biological nurturing may result to be protective for the neural basis of mother-newborn relationship, also in case of a postnatal affective suffering and helping to prevent its potential long term consequences on maternal wellbeing and infant neurodevelopment as well. Moreover, since oxytocin is a neuropeptide with widespread influence on parental function, including lactation and nurturing maternal behaviour physiology, if a biological nurturing approach to breastfeeding may promote the oxytocin level in the mother and/or in the newborn is worth to understand as well, taking into account again possible relations with postpartum depression symptoms. the aim of this study is to evaluate, by fNIRS hyperscanning, if the frontal cerebral cortex functional synchronization of mother-newborn dyads, who adopt a reciprocal positioning according to the biological nurturing approach during breastfeeding, differs from that of mother-newborn dyads adopting the standard position, taking into account the intensity of mother's postpartum depressive symptoms.", 'detailedDescription': "Breastfeeding is a very important experience since the beginning of life, supplying the best physical, biological and affective conditions for newborn's growth and development. Its promotion of motor, cognitive (e.g. language, memory), and emotional development in the long term was also observed. Benefits are for the mother too, including a reduction of the risk for postpartum depression. This clinical condition is the most common maternal psychiatric disorder after childbirth, observed in 10%-15% of mothers, and may adversely affect mother-newborn relationship, psychophysical maternal wellbeing, and infant development.\n\nDifferent reciprocal positions of mother and newborn during breastfeeding may be adopted. Other than the one derived from UNICEF guidelines, or standard position, an approach called biological nurturing has been recently proposed. It aims to promote the activation of neonatal primitive reflexes, breast problems reduction (e.g. cracked or sore nipple) and, overall, spontaneity and naturalness of mother-newborn dyad behaviour during feeding.\n\nNewborn cortical activation associated with breastfeeding was studied too. By functional near-infrared spectroscopy (fNIRS), a safe and minimally invasive functional neuroimaging technique based on haemoglobin absorption of near-infrared light, our research group showed that baby's cortex exhibit a wide activation associated with breastfeeding. Moreover, preliminary and not yet published data, collected by fNIRS hyperscanning (e.g. the simultaneous detection of brain functional activation from two individuals living the same experience) in the Nursery of our Institute, evidenced that mother-newborn dyads adopting a biological nurturing approach to breastfeeding show a neural synchronization between their frontal cortex during such experience. Basing on this new evidence, it is now worth to understand if a biological nurturing approach to breastfeeding may promote such neural synchronization, even when postpartum depressive symptoms are present. Accordingly, biological nurturing may result to be protective for the neural basis of mother-newborn relationship, also in case of a postnatal affective suffering and helping to prevent its potential long term consequences on maternal wellbeing and infant neurodevelopment as well. Moreover, since oxytocin is a neuropeptide with widespread influence on parental function, including lactation and nurturing maternal behaviour physiology, if a biological nurturing approach to breastfeeding may promote the oxytocin level in the mother and/or in the newborn is worth to understand as well, taking into account again possible relations with postpartum depression symptoms. the aim of this study is to evaluate, by fNIRS hyperscanning, if the frontal cerebral cortex functional synchronization of mother-newborn dyads, who adopt a reciprocal positioning according to the biological nurturing approach during breastfeeding, differs from that of mother-newborn dyads adopting the standard position, taking into account the intensity of mother's postpartum depressive symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Full term healthy newborns and their mothers.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Full term healthy newborn\n2. Weight \\> 2500 gr\n3. Vaginal delivery\n4. Breastfeeding already started\n5. Absence of breast problems (e.g. cracked or sore nipple)\n6. Parents' consent to research participation\n\nExclusion Criteria:\n\n1. Syndromic diagnosis (genetic/hereditary)\n2. Condition affecting a major organ (heart disease, cerebropathy, etc.)\n3. Medication intake that may interfere with the data collection (e.g. analgesics)\n4. Newborn head lesion that may interfere with the fNIRS assessment (e.g. due to an operative delivery)\n5. Mother history of neurological or neurosensory disorder, psychosis, bipolar disorder, and substance abuse or addiction."}, 'identificationModule': {'nctId': 'NCT05821569', 'briefTitle': 'Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding and Related Oxytocin Response, According to Different Reciprocal Positioning of the Dyad, and Possible Related Benefit for Postpartum Depressive Symptoms', 'orgStudyIdInfo': {'id': 'RC 53/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'standard position during breastfeeding', 'description': 'Women who adopted, according to their preference and/or to the professional advice and support of the nursing staff the standard position (derived from UNICEF guidelines) to breastfeed', 'interventionNames': ['Other: Standard approach']}, {'label': 'biological nurturing', 'description': 'Women who adopted, according to their preference and/or to the professional advice and support of the nursing staff, the biological nurturing approach to breastfeed', 'interventionNames': ['Other: Biological nurturing']}], 'interventions': [{'name': 'Standard approach', 'type': 'OTHER', 'description': 'Adoption of standard approach (derived by Unicef guidelines) to breastfeed', 'armGroupLabels': ['standard position during breastfeeding']}, {'name': 'Biological nurturing', 'type': 'OTHER', 'description': 'Adoption of biological nurturing approach to breastfeed', 'armGroupLabels': ['biological nurturing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34137', 'city': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Bembich, MD', 'role': 'CONTACT', 'email': 'stefano.bembich@burlo.trieste.it', 'phone': '+390403785410'}], 'facility': 'IRCCS Burlo Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'centralContacts': [{'name': 'Stefano Bembich, MSC', 'role': 'CONTACT', 'email': 'stefano.bembich@burlo.trieste.it', 'phone': '+390403785111'}], 'overallOfficials': [{'name': 'Stefano Bembich, MSC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS materno infantile Burlo Garofolo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}