AzTrials
AzTrials

NewbornNCT04337229

Evaluation of Comfort Behavior Levels of Newborns With Artificial Intelligence Techniques

A study testing Artifical intelligent in people with Newborn and Comfort, run by Eskisehir Osmangazi University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 1 hour to 28 days
Conditions the study is for
Newborn, Comfort, Nursing
What is being tested?
Artifical intelligent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
No sites listed yet
Study dates
Sep 2020to Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

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 1 hour to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

DENİZ YİĞİT, Res.Asst. contact

05428092848

deniz.yigit@dpu.edu.tr

AYFER ACIKGOZ, Assoc.Dr. contact

05352919374

ayferackgoz@gmail.com

About this study

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.

Read the 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.

Being tested
Artifical intelligent
Keywords
newborn, comfort, nursing, artificial intelligence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artifical intelligentOther

    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.

Study groups in NCT04337229
Study groupRoleWhat they receive
artificial intelligence techniquesExperimentalFacial 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.
Receives: Other: Artifical intelligent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Images of the 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.

    Measured: 12 hours for each newborn

Secondary outcomes (1)

  1. Artificial intelligence techniques

    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.

    Measured: Approximately 1 week for each newborn

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study startSep 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04337229
Sponsor's protocol ID
DYIGIT
Other IDs
Ayfer ACIKGOZ
Status last verified
Apr 2020
First submitted
2 Apr 2020
Last updated
13 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992 Feb;17(1):95-109. doi: 10.1093/jpepsy/17.1.95.

    PubMed 1545324

  • Arroyo-Novoa CM, Figueroa-Ramos MI, Puntillo KA, Stanik-Hutt J, Thompson CL, White C, Wild LR. Pain related to tracheal suctioning in awake acutely and critically ill adults: a descriptive study. Intensive Crit Care Nurs. 2008 Feb;24(1):20-7. doi: 10.1016/j.iccn.2007.05.002. Epub 2007 Aug 6.

    PubMed 17689249

  • Arslan, H., & Konuk Şener, D. (2009). Stigma, spiritüalite ve konfor kavramlarının Meleis' in kavram geliştirme sürecine göre irdelenmesi. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 2(1): 51-58.

  • Atalay, M., & Çelik, E. (2017). Büyük veri analizinde yapay zekâ ve makine öğrenmesi uygulamaları. Mehmet Akif Ersoy Üniversitesi Sosyal Bilimler Enstitüsü Dergisi, 9(22): 155-172.

  • Aydın, Ş.E. (2017). Yapay zeka teknolojisi (yapay zekaların dünü bugünü yarını), Yüksek lisans tezi, Çukurova Üniversitesi, Adana.

  • Bodur, G., & Kaya, H. (2017). Hemşirelerin gözüyle gelecek: 2050'li yıllar. Ege Üniversitesi Hemşirelik Fakültesi Dergisi, 33 (1): 27-38.

  • Coughlin M, Gibbins S, Hoath S. Core measures for developmentally supportive care in neonatal intensive care units: theory, precedence and practice. J Adv Nurs. 2009 Oct;65(10):2239-48. doi: 10.1111/j.1365-2648.2009.05052.x.

    PubMed 19686402

  • Çınar Yücel Ş. (2011). Kolcaba'nın konfor kuramı. Ege Üniversitesi Hemşirelik Yüksek Okulu Dergisi, 27: 79-88.

  • Çimen, Ü. (2016). Solunum seslerinin yapay zekâ ortamında sınıflandırılması, Yüksek Lisans Tezi, Afyon Kocatepe Üniversitesi Fen Bilimleri Enstitüsü, Afyonkarahisar.

  • de Sousa Freire NB, Garcia JBS, Lamy ZC. Evaluation of analgesic effect of skin-to-skin contact compared to oral glucose in preterm neonates. Pain. 2008 Sep 30;139(1):28-33. doi: 10.1016/j.pain.2008.02.031. Epub 2008 Apr 22.

    PubMed 18434021

  • Hunter, J. (2010). Therapeutic positioning: neuromotor, physiologic, and sleep implications. Developmental care of newborns and infants. A guide for health professionals. 2nd edn. Glenview, IL: NANN: 283-312.

  • Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.

    PubMed 15636661

  • Kahraman, A., Başbakkal, Z., & Yalaz, M. (2014). Yenidoğan konfor davranış ölçeği'nin Türkçe geçerlik ve güvenirliği. Uluslararası Hakemli Hemşirelik Araştırmaları Dergisi, 1(2).

  • Karabacak, Ü., & Acaroğlu, R. (2011). Konfor kuramı. Maltepe Üniversitesi Bilim ve Sanat Dergisi, 4(1): 197-202.

  • Karakaplan, S., & Yıldız, H. (2010). Doğum sonu konfor ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1): 55-65.

Questions about this trial

What is this clinical trial studying?

A study testing Artifical intelligent in people with Newborn and Comfort, run by Eskisehir Osmangazi University.

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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact DENİZ YİĞİT, Res.Asst. (05428092848, deniz.yigit@dpu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Images of the newborn (time frame: 12 hours for each newborn). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04337229, which also lists 29 linked publications.

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 13 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in