Accepted for/Published in: JMIR Biomedical Engineering
Date Submitted: Sep 5, 2023
Date Accepted: Oct 27, 2023
Assessment of skin maturity by LED light at birth and its association with lung maturity: clinical trial secondary outcomes
ABSTRACT
Background:
Clinicians face barriers when assessing lung maturity at birth due to global inequalities. Still, strategies for testing based solely on gestational age to predict the likelihood of respiratory distress syndrome (RDS) do not offer a comprehensive approach to addressing the challenge of uncertain outcomes. We hypothesize that a noninvasive assessment of skin maturity may indicate lung maturity.
Objective:
To assess the association between the newborn’s skin maturity with RDS occurrence.
Methods:
We conducted a nested case-control prospective in a cohort study, a secondary endpoint of a multicenter clinical trial. The study was carried out in five Brazilian urban reference centres for highly complex perinatal care. Of 781 newborns from the cohort study, 640 were selected for the case-control analysis. Newborns with RDS and without respiratory diagnosis formed the case and control groups, respectively. Skin maturity was assessed from the newborn's skin over the sole by an optical device that acquired a reflection signal through a light-emitting diode sensor. Clinical data related to respiratory outcomes were collected from medical records during 72-hours after birth. The main outcome measure was the association between skin reflectance and the occurrence of RDS, using univariate and multivariate binary logistic regression. Additionally, we assessed the connection between skin reflectance and factors such as NICU admission and the need for ventilatory support.
Results:
Skin reflectance was associated with RDS, Exp(B): .982 (95% CI: .979 to .985), R2 .632, p<.001. This relationship kept significance when adjusted by cofactors of antenatal corticosteroid and birth weight, Exp(B): .994 (95% CI: .990 to .998), model R2 .843, p<.001. Secondary outcomes also showed differences in skin reflectance between Yes vs. No groups. The mean difference was .219 (95% CI: .200 to .238) and .223 (95% CI: .205 to .241) for ventilatory support and NICU admission analysis, respectively.
Conclusions:
Our findings present a potential marker of lung immaturity at birth by an indirect method of skin assessment. Using the RDS clinical condition and a medical device, this study signalised the synchrony between lung and skin maturity. Clinical Trial: RBR-3f5bm5
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