Assessment of Skin Maturity by LED Light at Birth and Its Association With Lung Maturity: Clinical Trial Secondary Outcomes (Preprint)

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 This study aimed to assess the association between a newborn’s skin maturity and RDS occurrence. METHODS We conducted a case-control nested in a prospective cohort study, a secondary endpoint of a multicenter clinical trial. The study was carried out in 5 Brazilian urban reference centers for highly complex perinatal care. Of 781 newborns from the cohort study, 640 were selected for the case-control analysis. Newborns with RDS formed the case group and newborns without RDS were the controls. All newborns with other diseases exhibiting respiratory manifestations were excluded. Skin maturity was assessed from the newborn's skin over the sole by an optical device that acquired a reflection signal through an LED sensor. The device, previously validated, measured and recorded skin reflectance. Clinical data related to respiratory outcomes were gathered from medical records during the 72-hour follow-up of the newborn, or until discharge or death, whichever occurred first. The main outcome measure was the association between skin reflectance and RDS using univariate and multivariate binary logistic regression. Additionally, we assessed the connection between skin reflectance and factors such as neonatal intensive care unit (NICU) admission and the need for ventilatory support. RESULTS Out of 604 newborns, 470 (73.4%) were from the RDS group and 170 (26.6%) were from the control group. According to comparisons between the groups, newborns with RDS had a younger gestational age (31.6 vs 39.1 weeks, <i>P</i><.001) and birth weight (1491 vs 3121 grams, <i>P</i><.001) than controls. Skin reflectance was associated with RDS (odds ratio [OR] 0.982, 95% CI 0.979-0.985, <i>R</i><sup>2</sup>=0.632, <i>P<</i>.001). This relationship remained significant when adjusted by the cofactors antenatal corticosteroid and birth weight (OR 0.994, 95% CI 0.990-0.998, <i>R</i><sup>2</sup>=0.843, <i>P<</i>.001). Secondary outcomes also showed differences in skin reflectance. The mean difference was 0.219 (95% CI 0.200-0.238) between newborns that required ventilatory support versus those that did not and 0.223 (95% CI 0.205-0.241) between newborns that required NICU admission versus those that did not. Skin reflectance was associated with ventilatory support (OR 0.996, 95% CI 0.992-0.999, <i>R</i><sup>2</sup>=0.814, <i>P</i>=.01) and with NICU admission (OR 0.994, 95% CI 0.990-0.998, <i>R</i><sup>2</sup>=0.867, <i>P</i>=.004). CONCLUSIONS Our findings present a potential marker of lung immaturity at birth using the indirect method of skin assessment. Using the RDS clinical condition and a medical device, this study demonstrated the synchrony between lung and skin maturity. CLINICALTRIAL Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-3f5bm5; https://tinyurl.com/9fb7zrdb INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2018-027442