Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-04-15 @ 2:46 PM
Study NCT ID:
NCT01012505
Status:
UNKNOWN
Last Update Posted:
2009-11-13
First Post:
2009-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-11-12', 'studyFirstSubmitDate': '2009-11-11', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Health Preterm Infants With no Active Disease', 'Human Milk Nutrition', 'Incubator Stay']}, 'descriptionModule': {'briefSummary': "Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. Experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant.\n\nProvision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'minimumAge': '7 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'preterm infants at least 1 weekk of age no active disease or treatment (like respiratory support) place in incubator', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants at least 1 week of age\n* no active disease or treatment (like respiratory support)\n* place in incubator\n\nExclusion Criteria:\n\n* active disease or treatment'}, 'identificationModule': {'nctId': 'NCT01012505', 'briefTitle': 'The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.', 'orgStudyIdInfo': {'id': 'SHEBA-09-7392-AM-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': '20 preterm infants', 'description': '20 preterm infants without active disease', 'interventionNames': ['Other: adding pad with maternal milk in hte incubator']}], 'interventions': [{'name': 'adding pad with maternal milk in hte incubator', 'type': 'OTHER', 'description': '2 days prior to intervention - recording infants data and taking saliva cortisol adding pad with maternal milk - during 2 days - recording infants data and taking saliva cortisol.\n\nstopping intervention and for other 2 days recording infants data and taking saliva cortisol', 'armGroupLabels': ['20 preterm infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'contacts': [{'name': 'Ayala Maayan-Metzger, Dr.', 'role': 'CONTACT', 'email': 'maayan@post.tau.ac.il', 'phone': '972-3-5302227'}], 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Ayala Maayan', 'oldOrganization': 'Sheba Medical Cener'}}}}