Neves Gabriela Silveira, Reis Zilma Silveira Nogueira, Romanelli Roberta, Batchelor James
Faculty of Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
Faculty of Medicine, University of Southampton, Southampton, United Kingdom.
JMIR Biomed Eng. 2023 Dec 25;8:e52468. doi: 10.2196/52468.
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.
This study aimed to assess the association between a newborn's skin maturity and RDS occurrence.
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.
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, P<.001) and birth weight (1491 vs 3121 grams, P<.001) than controls. Skin reflectance was associated with RDS (odds ratio [OR] 0.982, 95% CI 0.979-0.985, R=0.632, P<.001). This relationship remained significant when adjusted by the cofactors antenatal corticosteroid and birth weight (OR 0.994, 95% CI 0.990-0.998, R=0.843, P<.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, R=0.814, P=.01) and with NICU admission (OR 0.994, 95% CI 0.990-0.998, R=0.867, P=.004).
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.
Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-3f5bm5; https://tinyurl.com/9fb7zrdb.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-027442.
由于全球不平等现象，临床医生在评估出生时的肺成熟度时面临障碍。然而，仅基于胎龄来预测呼吸窘迫综合征（RDS）可能性的检测策略并不能提供全面的方法来应对结果不确定的挑战。我们假设对皮肤成熟度进行无创评估可能表明肺成熟度。
本研究旨在评估新生儿皮肤成熟度与RDS发生之间的关联。
我们在一项前瞻性队列研究中进行了病例对照研究，这是一项多中心临床试验的次要终点。该研究在巴西5个提供高度复杂围产期护理的城市参考中心进行。在队列研究的781名新生儿中，选择640名进行病例对照分析。患有RDS的新生儿组成病例组，无RDS的新生儿为对照组。所有患有其他表现出呼吸症状疾病的新生儿均被排除。通过一种光学设备从新生儿足底皮肤评估皮肤成熟度，该设备通过LED传感器获取反射信号。该设备先前已得到验证，可测量并记录皮肤反射率。在新生儿72小时随访期间，或直至出院或死亡（以先发生者为准），从医疗记录中收集与呼吸结局相关的临床数据。主要结局指标是使用单变量和多变量二元逻辑回归分析皮肤反射率与RDS之间的关联。此外，我们评估了皮肤反射率与新生儿重症监护病房（NICU）入院及通气支持需求等因素之间的联系。
在604名新生儿中，470名（73.4%）来自RDS组，170名（26.6%）来自对照组。根据两组间的比较，患有RDS的新生儿胎龄（31.6周对39.1周，P<0.001）和出生体重（1491克对3121克，P<0.001）均低于对照组。皮肤反射率与RDS相关（比值比[OR]0.982，95%可信区间0.979 - 0.985，R = 0.632，P<0.001）。在通过产前皮质类固醇和出生体重等协变量进行调整后，这种关系仍然显著（OR 0.994，95%可信区间0.990 - 0.998，R = 0.843，P<0.001）。次要结局也显示出皮肤反射率存在差异。需要通气支持的新生儿与不需要通气支持的新生儿之间的平均差异为0.219（95%可信区间0.200 - 0.238），需要入住NICU的新生儿与不需要入住NICU的新生儿之间的平均差异为0.223（95%可信区间0.205 - 0.241）。皮肤反射率与通气支持相关（OR 0.996，95%可信区间0.992 - 0.999，R = 0.814，P = 0.01），与入住NICU相关（OR 0.994，95%可信区间0.990 - 0.998，R = 0.867，P = 0.004）。
我们的研究结果通过皮肤评估的间接方法呈现了出生时肺不成熟的一个潜在标志物。利用RDS临床情况和一种医疗设备，本研究证明了肺成熟度与皮肤成熟度之间的同步性。
巴西临床试验注册中心（ReBEC）RBR - 3f5bm5；https://tinyurl.com/9fb7zrdb。
国际注册报告识别码（IRRID）：RR2 - 10.1136/bmjopen - 2018 - 027442。
