背景:由于全球不平等,临床医生在评估出生时的肺成熟度时面临障碍。尽管如此,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不确定结局的挑战.我们假设对皮肤成熟度的非侵入性评估可能表明肺成熟度。
目的:本研究旨在评估新生儿皮肤成熟度与RDS发生之间的关系。
方法:我们在一项前瞻性队列研究中进行了病例对照嵌套,多中心临床试验的次要终点.这项研究是在巴西的5个城市参考中心进行的,用于高度复杂的围产期护理。在队列研究的781名新生儿中,病例对照分析选择640例。以RDS新生儿为病例组,无RDS新生儿为对照。排除所有具有其他表现为呼吸道疾病的新生儿。通过通过LED传感器获得反射信号的光学设备从新生儿的皮肤超过鞋底评估皮肤成熟度。该装置,以前验证过,测量并记录皮肤反射率。在新生儿72小时随访期间,从病历中收集与呼吸结局相关的临床数据。或者直到出院或死亡,以先发生者为准。主要结果测量是使用单变量和多变量二元逻辑回归的皮肤反射率和RDS之间的关联。此外,我们评估了皮肤反射与新生儿重症监护病房(NICU)入院和需要通气支持等因素之间的联系.
结果:在604名新生儿中,470(73.4%)来自RDS组,170(26.6%)来自对照组。根据两组之间的比较,RDS新生儿胎龄较小(31.6vs39.1周,P<.001)和出生体重(1491vs3121克,P<.001)比对照组。皮肤反射与RDS相关(比值比[OR]0.982,95%CI0.979-0.985,R2=0.632,P<.001)。当由产前皮质类固醇和出生体重的辅因子调整时,这种关系仍然显着(OR0.994,95%CI0.990-0.998,R2=0.843,P<.001)。次要结果也显示了皮肤反射率的差异。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%CI0.200-0.238),需要NICU入院的新生儿与不需要NICU的新生儿之间的平均差异为0.223(95%CI0.205-0.241)。皮肤反射与通气支持相关(OR0.996,95%CI0.992-0.999,R2=0.814,P=0.01)和NICU入院相关(OR0.994,95%CI0.990-0.998,R2=0.867,P=.004)。
结论:我们的发现使用间接皮肤评估方法,提供了出生时肺不成熟的潜在标志。使用RDS临床状况和医疗设备,这项研究证明了肺和皮肤成熟之间的同步性。
背景:注册BrasileirodeEnsaiosClínicos(ReBEC)RBR-3f5bm5;https://tinyurl.com/9fb7zrdb.
■RR2-10.1136/bmjopen-2018-027442。
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, 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, R2=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, R2=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, R2=0.814, P=.01) and with NICU admission (OR 0.994, 95% CI 0.990-0.998, R2=0.867, P=.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.
BACKGROUND: Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-3f5bm5; https://tinyurl.com/9fb7zrdb.
UNASSIGNED: RR2-10.1136/bmjopen-2018-027442.