Oral HistoryNCT06176950
History of Neonatology
An observational study of Oral History, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral History
- What is being tested?
- Oral History Interviews
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: individuals who have worked in NICUs [neonatologists, nurses, social workers] in the 20th and/or early 21st century
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers University
New Brunswick, New Jersey, 08901
Johanna Schoen, PhD, 7347573376, johanna.schoen@rutgers.edu
About this study
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. The investigator will be using oral history interviews as one source for a book that will document developments in the history of neonatology. The investigator will identify potential research subjects through their publications in the field of neonatology and through word of mouth. The investigator will locate them via the contact information provided in their publications or through an internet search.
Read the detailed description
The investigator 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 extensive research of the medical literature and other pertinent publications.
Between 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. The investigator is 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. The investigator 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.
There 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.
- Conditions
- Oral History
- Being tested
- Oral History Interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral History InterviewsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Information about the history of neonatology
Interviews will be transcribed and indexed by key words pertaining to the history of NICUs
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start4 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HistoryStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Schoen, PhD, Rutgers, The State University of New Jersey
- Investigators
- Johanna Schoen, PhD, Principal investigator, Johanna Schoen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176950
- Sponsor's protocol ID
- Pro2021000877
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- History of Neonatology
- ClinicalTrials.gov ID
- NCT06176950
- Acronym / sponsor ID
- Pro2021000877
- Conditions
- Oral History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigator will be using oral history interviews as one source for a book that will document developments in the history of neonatology. The investigator will identify potential research subjects through their publications in the field of neonatology and through word of mouth. The investigator will locate them via the contact information provided in their publications or through an internet search.
Detailed description
The investigator 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 extensive research of the medical literature and other pertinent publications.
Between 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. The investigator is 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. The investigator 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.
There 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- individuals who have worked in NICUs [neonatologists, nurses, social workers] in the 20th and/or early 21st century
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral History InterviewsI 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. | Other | – |
Primary outcome
Information about the history of neonatology
Time frame: 2 hours
Interviews will be transcribed and indexed by key words pertaining to the history of NICUs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johanna Schoen, PhD principal investigator
Johanna Schoen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral History, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Schoen, PhD (7347573376, johanna.schoen@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information about the history of neonatology (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.