Infrared Thermography and Apgar Score (VIRGINA)

Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn

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).

Study Overview

• Status: Unknown
• Conditions: Newborn, Transient
• Intervention / Treatment: Other: Thermography

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Poissy, France, 78300
    • Recruiting
    • Poissy Saint Germain Hospital
    • Contact: Mathilde P. Letouzey, MD; Phone Number: +33139274430; Email: mathilde.letouzey@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 minutes (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Term newborn, born after cesarean delivery, without congenital anomalies

Description

Inclusion Criteria:

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

Exclusion Criteria:

• parents refusal
• congenital anomalies

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Poissy-Saint Germain Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): July 23, 2020
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: thermography; apgar score
• Other Study ID Numbers: 2020-A00265-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No