Clinical trial NCT04483869: Infrared Thermography and Apgar Score
Official title: Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Newborn, Transient
Keywords: thermography
apgar score
Lead sponsor: Poissy-Saint Germain Hospital
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 200
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term newborn, born after cesarean delivery, without congenital anomalies

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* parents refusal
* congenital anomalies

Primary outcomes:
measure: thermographic image
timeFrame: 1 minute of life
measure: thermographic image
timeFrame: 5 minutes of life
measure: thermographic image
timeFrame: 10 minutes of life
Secondary outcomes:
Other outcomes:
Locations:
city: Poissy
country: France
facility: Poissy Saint Germain Hospital
Study officials:
References: