Newborn, TransientVIRGINANCT04483869
Infrared Thermography and Apgar Score
An observational study of Newborn, Transient, run by Poissy-Saint Germain Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 15 minutesHealthy volunteers can take part
- Conditions the study is for
- Newborn, Transient
- What is being tested?
- Thermography
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2020to Jul 2022
- Phase
- Observational
- 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 Up to 15 minutes
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term newborn, born after cesarean delivery, without congenital anomalies
Who may be able to join
- term infants, gestational age ≥ 37 weeks of gestation
- cesarean delivery
- maternal age ≥ 18 years
Who cannot join
- parents refusal
- congenital anomalies
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Poissy Saint Germain Hospital
Poissy, 78300
Mathilde P. Letouzey, MD, +33139274430, mathilde.letouzey@gmail.com
About this study
Official title: 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.
Read more
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).
- Conditions
- Newborn, Transient
- Being tested
- Thermography
- Keywords
- thermography, apgar score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermographyOther
thermographic image a 1, 3, 5 et 10 minutes of life
What is being measured
The primary outcome is the main question the study is designed to answer.
thermographic image
Correlation between thermographic image and Apgar score
Measured: 1 minute of life
thermographic image
Correlation between thermographic image and Apgar score
Measured: 5 minutes of life
thermographic image
Correlation between thermographic image and Apgar score
Measured: 10 minutes of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start23 Jul 2020
- Primary completion23 Jul 2020
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newborn, TransientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathilde Letouzey, MD, Poissy-Saint Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483869
- Sponsor's protocol ID
- 2020-A00265-34
- Acronym
- VIRGINA
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41458084
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn
- ClinicalTrials.gov ID
- NCT04483869
- Acronym / sponsor ID
- VIRGINA / 2020-A00265-34
- Conditions
- Newborn, Transient
- Keywords
- thermography, apgar score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- Jul 2022 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 15 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term newborn, born after cesarean delivery, without congenital anomalies
Key inclusion criteria (3 listed)
- term infants, gestational age ≥ 37 weeks of gestation
- cesarean delivery
- maternal age ≥ 18 years
Key exclusion criteria (2 listed)
- parents refusal
- congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermographythermographic image a 1, 3, 5 et 10 minutes of life | Other | – |
Primary outcome
thermographic image
Time frame: 1 minute of life
Correlation between thermographic image and Apgar score
thermographic image
Time frame: 5 minutes of life
Correlation between thermographic image and Apgar score
thermographic image
Time frame: 10 minutes of life
Correlation between thermographic image and Apgar score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Derived from this study: PubMed 41458084Letouzey 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn, Transient, run by Poissy-Saint Germain Hospital at 1 site in France.
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 3 inclusion and 2 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thermographic image (time frame: 1 minute of life). The study lists 3 primary outcomes in all. 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 NCT04483869, which also lists 1 linked publication.
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 27 Jul 2020.