Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-09 @ 1:39 PM
Study NCT ID:
NCT06176950
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
History of Neonatology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Information about the history of neonatology', 'timeFrame': '2 hours', 'description': 'Interviews will be transcribed and indexed by key words pertaining to the history of NICUs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral History']}, 'descriptionModule': {'briefSummary': 'This study traces the history of neonatology in the United States from the 1960s to the present with particular attention to the ways in which neonatologists developed criteria to make treatment decisions. I will be using oral history interviews as one source for a book that will document developments in the history of neonatology. I will identify potential research subjects through their publications in the field of neonatology and through word of mouth. I will locate them via the contact information provided in their publications or through an internet search.', 'detailedDescription': 'I will interview individuals who have worked in NICUs \\[neonatologists, nurses, social workers\\] to understand how technological changes and changing scientific understanding influenced decision making pertaining to the treatment of infants. The interviews will supplement my extensive research of the medical literature and other pertinent publications.\n\nBetween the 1960s and the present, we have seen the emergence of medical therapies and technologies developed to treat neonates. Over this time period, there has also been a changing and growing understanding of the long-term impact that medical interventions have on the infants treated as well as on their families. Finally, the demographic characteristics of neonates have also changed as public health crises as well as the development of modern reproductive technologies led to new patient populations and new expectations of what NICUs should or should not achieve. I am interested in the ways in which these changes have led to evolving treatment criteria for neonates and ways in which neonatologists decided when to treat and when treatment was considered futile. I will interview medical professionals who are working or have worked at NICUs about the changes they experienced in their place of work over the course of their careers, the impact that medical technologies and changing patient populations had on considerations about treatment options, and the discussions they had with colleagues and the parents of patients.\n\nThere is to date no sustained historical analysis of neonatology. There are anthropological studies of the development of fetal surgery \\[Casper 1998\\] as well as Assisted Reproductive Technologies \\[Spar, 2006; Thompson, 2005\\]. There are analyses of the social history of particular medical interventions \\[abortion, birth control, etc.\\] \\[Schoen, 1995; Schoen 2005\\] and the treatment of the fetus \\[Withycombe, 2019\\]. And scholars have discussed the value of reproduction and the fetus as it pertains to emerging technologies of genetic testing and the history of disability \\[Davis, 2019; Herzog, 2018; Lowy, 2018; Maienschein, 2003; Maienschein, 2014; Rapp, 2000; Reagan, 2010.\\] This study will contribute to our understanding of the ways in which medical professionals have made decisions about life, death, and the quality of life of those being treated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'individuals who have worked in NICUs \\[neonatologists, nurses, social workers\\] in the 20th and/or early 21st century', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: I will interview individuals who worked or are working in Neonatal Intensive Care Units as neonatologists, pediatricians, nurses, social workers or other pertinent professionals in the medical or counseling field.\n\nExclusion Criteria: N/A\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06176950', 'briefTitle': 'History of Neonatology', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'History of Neonatology', 'orgStudyIdInfo': {'id': 'Pro2021000877'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oral History Interviews', 'type': 'OTHER', 'description': 'I will ask interview subjects about their educational and career path, their research interests and clinical work in the field of neonatology. I will also ask them about their personal and professional motivations and thoughts about their work. And we will discuss how their interactions with colleagues and patients/caregivers shaped their work experience and decision making.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Johanna Schoen, PhD', 'role': 'CONTACT', 'email': 'johanna.schoen@rutgers.edu', 'phone': '734-757-3376'}], 'facility': 'Rutgers University', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'centralContacts': [{'name': 'Johanna Schoen, PhD', 'role': 'CONTACT', 'email': 'johanna.schoen@rutgers.edu', 'phone': '7347573376'}], 'overallOfficials': [{'name': 'Johanna Schoen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johanna Schoen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'December 2028 anticipated', 'ipdSharing': 'YES', 'description': 'If interview subjects agree, I will donate the interviews to the American Academia of Pediatrics which has an archive of oral histories with pediatricians and neonatologists.', 'accessCriteria': 'anyone who wishes to access the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of History', 'investigatorFullName': 'Johanna Schoen, PhD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}