Evaluation of Comfort Behavior Levels of Newborns With Artificial Intelligence Techniques

April 9, 2020 updated by: DENİZ YİĞİT, Eskisehir Osmangazi University
This study; It will be carried out with the aim of developing the artificial intelligence method, which allows automatic determination of comfort levels of newborns.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study; It will be carried out with the aim of developing the artificial intelligence method, which allows automatic determination of comfort levels of newborns. Facial and body movements of newborns will be recorded by camera, and images will be processed in computer environment by using artificial intelligence techniques. As a result, it is planned to create a technology that determines the comfort level of the newborn quickly and simply and can be used by the mobile device.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

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 Backup

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

Ages Eligible for Study

1 hour to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parents' acceptance of their baby's participation in the study
  • Having a baby born at 24-42 weeks

Exclusion Criteria:

  • Having a baby born before 24 weeks of gestation or after 42 weeks of gestation.
  • Has received analgesic, muscle relaxant or sedative drug treatment that may affect comfort and behavior (last 24 hours)
  • Newborn has serious neurological damage

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: artificial intelligence techniques
Facial and body movements of newborns will be recorded by camera, and images will be processed in computer environment by using artificial intelligence techniques. As a result, it is planned to create a technology that determines the comfort level of the newborn quickly and simply and can be used by the mobile device.
Other: Artifical intelligent
it is planned to create a technology that determines the comfort level of the newborn quickly and simply, easy to use, time-saving and can be used by the mobile device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Images of the newborn
Time Frame: 12 hours for each newborn
Images will be taken to transfer behaviors of newborns to the computer. Attention will be paid to making face and body movements visible while taking the image.The camera will take 12 hours of view of each newborn.However, this period can be shortened as a result of preliminary work.
12 hours for each newborn

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Artificial intelligence techniques
Time Frame: Approximately 1 week for each newborn
The images of the newborn will be transferred to the computer. The images will be processed by a specialist on computer using artificial intelligence techniques.
Approximately 1 week for each newborn

Collaborators and Investigators

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

Sponsor

Eskisehir Osmangazi University

Investigators

  • Principal Investigator: DENİZ YİĞİT, Res.Asst., ESKİŞEHİR OSMANGAZİ ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DYIGIT
  • Ayfer AÇIKGÖZ (Other Identifier: ESKİŞEHİR OSMANGAZİ ÜNİVERSİTESİ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the end of the study, it is aimed to announce the artificial intelligence developed to measure comfort with the declaration to be made in international congresses. In this way, it is thought that the program will be used by healthcare professionals in different hospitals and neonatal clinics in these hospitals.

IPD Sharing Time Frame

It will be shared after the study is finished (About 2 years later)

IPD Sharing Access Criteria

Being a healthcare professional working with newborns

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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