Newborn, Transient Clinical Trial
— VIRGINAOfficial title:
Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn
| NCT number | NCT04483869 |
| Other study ID # | 2020-A00265-34 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 23, 2020 |
| Est. completion date | July 2022 |
| Verified date | July 2020 |
| Source | Poissy-Saint Germain Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | July 2022 |
| Est. primary completion date | July 23, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 15 Minutes |
| Eligibility |
Inclusion Criteria: - term infants, gestational age = 37 weeks of gestation - cesarean delivery - maternal age = 18 years Exclusion Criteria: - parents refusal - congenital anomalies |
| Country | Name | City | State |
|---|---|---|---|
| France | Poissy Saint Germain Hospital | Poissy |
| Lead Sponsor | Collaborator |
|---|---|
| Poissy-Saint Germain Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | thermographic image | Correlation between thermographic image and Apgar score | 1 minute of life | |
| Primary | thermographic image | Correlation between thermographic image and Apgar score | 5 minutes of life | |
| Primary | thermographic image | Correlation between thermographic image and Apgar score | 10 minutes of life |