Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns

May 13, 2023 updated by: Andrey Mikhailovich Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
The purpose of this work is to assess the functional state of the body of medical workers in the neonatal resuscitation and intensive care unit in the conditions of work.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
17

Contacts and Locations

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

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 105275
        • Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy medical workers in neonatal intensive care unit

Description

Inclusion Criteria:

  • the volunteer has practical experience in the neonatal intensive care unit
  • digestive tract, kidney, cardiorespiratory system, mervous system or musculoskeletal system pathology

Exclusion Criteria:

  • acute and chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys
  • body temperature above 37 ° C, heart rate over 90 beats / min, systolic and diastolic blood pressure above 140 mm Hg. Art. and 90 mm Hg. Art.
  • organic brain lesions, increased convulsive activity in history
  • receiving more than 10 units. alcohol per week or history of alcoholism, drug addiction, drug abuse

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
medical workers
medical workers of the resuscitation and intensive care unit of newborns
Other: work conditions
an increased degree of responsibility for the life of newborns, high psycho-emotional stress, intellectual stress, an irrational work and rest regime, in connection with the COVID-19 pandemic, also using personal protective equipment against biological factors

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
Heart rate
Time Frame: 8 hours
bpm, "Armed": "YE-630A" (ТМ "ARMED", Russia)
8 hours
Blood pressure
Time Frame: 8 hours
mm Hg, "Armed": "YE-630A" (ТМ "ARMED", Russia)
8 hours
Anthropometry (Height)
Time Frame: 1 hour
Height (cm), weight (kg), Seca 703 ("Seca GMBH&Co", Germany)
1 hour
Anthropometry (Weight)
Time Frame: 1 hour
Weight (kg), Seca 703 ("Seca GMBH&Co", Germany)
1 hour
Body temperature
Time Frame: 1 hour
Celsius, Thermoval Standard ("PAUL HARTMANN", Germany)
1 hour
Electrocardiography
Time Frame: 1 hour
Electrocardiogram analysis, Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
1 hour
Cognitive functions test 1
Time Frame: 1 hour
Bourdon correction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
1 hour
Cognitive functions test 2
Time Frame: 1 hour
Simple visual-motor reaction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
1 hour
Cognitive functions test 3
Time Frame: 1 hour
Growing account test. Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survey
Time Frame: 1 hour
Subjective survey on functional state of the body (7 scales)
1 hour

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.
Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"

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: Inga Malakhova, Junior scientist

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.
August 29, 2022

Primary Completion (Actual)

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.
October 5, 2022

Study Completion (Actual)

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.
October 10, 2022

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).
August 4, 2022

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.
August 5, 2022

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.
August 8, 2022

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 16, 2023

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.
May 13, 2023

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.
May 1, 2023

More Information

Terms related to this study

Keywords

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.
  • PPE-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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