NCT04483869

Brief Summary

Background: The Apgar score assesses the newborn's adaptation in the first minutes of life. It is rated between 0 and 10 by the midwife, at 1-3-5 and 10 minutes of life. A low Apgar score at 5 minutes of life is associated with increased neonatal mortality and neurological impairment. However, this score has limitations and its measurement remains subjective: it does not guide resuscitation actions in the event of poor adaptation, significant inter-observer variability in scoring, variations according to the physiological maturation of the newborn, in particular according to gestational age. Infrared thermography is a rapidly developing imaging technique based on the measurement of infrared radiation. It is an accurate, reliable and easy instrument of providing rapid non-contact, non-invasive and non-irradiating diagnosis. A recent 2018 study showed that the use of thermography would allow accurate and non-invasive monitoring of newborns in neonatal intensive care unit for early diagnosis of certain pathologies such as infection. During the transition, during the first minutes of life, the circulatory and respiratory systems of the newborn change. Vasodilatation occurs progressively in the central and peripheral areas. Thermoregulation is also a crucial stage of adaptation. In view of this physiopathological knowledge, it seems interesting to correlate this adaptation , with the analysis of thermographic images. The principle of this technique is indeed based on the analysis of the heat emitted, and would thus make it possible to evaluate the blood perfusion of the newborn, and its evolution in the first minutes of life in an objective way. Our hypothesis is that a poor adaptation could be detected more efficiently on photographs taken at time T, contrary to the calculation of the Apgar score for which there are several limitations mentioned above. Main objective of the study: To study the ability of the thermographic image to objectively evaluate the adaptation to ectopic life of newborns compared to existing evaluations (Apgar, pH, Lactates).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 23, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

July 9, 2020

Last Update Submit

July 23, 2020

Conditions

Keywords

thermographyapgar score

Outcome Measures

Primary Outcomes (3)

  • thermographic image

    Correlation between thermographic image and Apgar score

    1 minute of life

  • thermographic image

    Correlation between thermographic image and Apgar score

    5 minutes of life

  • thermographic image

    Correlation between thermographic image and Apgar score

    10 minutes of life

Interventions

thermographic image a 1, 3, 5 et 10 minutes of life

Eligibility Criteria

AgeUp to 15 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Term newborn, born after cesarean delivery, without congenital anomalies

You may qualify if:

  • term infants, gestational age ≥ 37 weeks of gestation
  • cesarean delivery
  • maternal age ≥ 18 years

You may not qualify if:

  • parents refusal
  • congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poissy Saint Germain Hospital

Poissy, 78300, France

RECRUITING

Related Publications (1)

  • Letouzey M, Diop S, Kengoum CEP, Rousseau A, Hot N, Francois J, Quibel T, Berveiller P, Boileau P, Jouen F, Trabelsi I, Bergounioux J. Newborn clinical condition assessment using infrared thermography: correlation with the Apgar score in a prospective cohort study. Front Pediatr. 2025 Dec 12;13:1636667. doi: 10.3389/fped.2025.1636667. eCollection 2025.

MeSH Terms

Interventions

Thermography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisThermometryInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 23, 2020

Study Start

July 23, 2020

Primary Completion

July 23, 2020

Study Completion

July 1, 2022

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations