History of Neonatology

April 28, 2026 updated by: Johanna Schoen, PhD, Rutgers, The State University of New Jersey
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

individuals who have worked in NICUs [neonatologists, nurses, social workers] in the 20th and/or early 21st century

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Johanna Schoen, PhD, Johanna Schoen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2021000877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing Time Frame

December 2028 anticipated

IPD Sharing Access Criteria

anyone who wishes to access the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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