PDF(Pubmed)
Abstract：
Mortality and brain injury are common adverse outcomes in infants born <28 weeks. Conventional pulse oximetry may not detect subclinical changes prior to deterioration and fails to detect changes within the brain. Increasing evidence supports the use of cerebral near-infrared spectroscopy (NIRS) in the early care of preterm infants, yet the impact of specific interventions on cerebral oxygenation and the relationship between cerebral hypoxia and brain injury on MRI remain to be determined.
100 infants <28 completed weeks of gestation will be recruited for a prospective, multicenter intervention trial. After informed consent, infants will undergo cerebral NIRS monitoring starting within 6 h of birth and continuing through 72 h. Infants with persistent cerebral desaturation will receive interventions following a standard treatment algorithm selected by the provider based on the patient\'s clinical condition. Providers will record the timing and choice of intervention(s) and term equivalent brain MRI will be performed for survivors. There are three objectives of this study: 1) to identify the relationship between cerebral hypoxia burden and brain injury on term-equivalent MRI. 2) to identify most common interventions after cerebral hypoxia, and 3) to quantify frequency of occult cerebral hypoxia events.
There is increasing evidence for the role of early cerebral NIRS monitoring in the neuroprotective care of preterm infants. This phase-II trial will provide essential data to improve the intervention approach, model the effect size of interventions on a wider extent of brain injury, and quantify the discrepancy between measurements of systemic and cerebral hypoxia.
100 infants <28 completed weeks of gestation will be recruited for a prospective, multicenter intervention trial. After informed consent, infants will undergo cerebral NIRS monitoring starting within 6 h of birth and continuing through 72 h. Infants with persistent cerebral desaturation will receive interventions following a standard treatment algorithm selected by the provider based on the patient\'s clinical condition. Providers will record the timing and choice of intervention(s) and term equivalent brain MRI will be performed for survivors. There are three objectives of this study: 1) to identify the relationship between cerebral hypoxia burden and brain injury on term-equivalent MRI. 2) to identify most common interventions after cerebral hypoxia, and 3) to quantify frequency of occult cerebral hypoxia events.
There is increasing evidence for the role of early cerebral NIRS monitoring in the neuroprotective care of preterm infants. This phase-II trial will provide essential data to improve the intervention approach, model the effect size of interventions on a wider extent of brain injury, and quantify the discrepancy between measurements of systemic and cerebral hypoxia.
摘要：
死亡率和脑损伤是出生<28周的婴儿常见的不良后果。传统的脉搏血氧饱和度可能无法在恶化之前检测到亚临床变化，并且无法检测到大脑内的变化。越来越多的证据支持在早产儿的早期护理中使用脑近红外光谱（NIRS），然而,具体干预对脑氧合的影响以及脑缺氧与MRI脑损伤之间的关系仍有待确定.
将招募100名妊娠28周以下的婴儿进行前瞻性研究，多中心干预试验。知情同意后，婴儿将在出生后6小时内开始接受脑NIRS监测,并持续至72小时。患有持续性脑饱和度下降症的婴儿将按照提供者根据患者的临床状况选择的标准治疗算法接受干预.提供者将记录干预的时间和选择，并对幸存者进行术语等效脑MRI。本研究的目标有三个：1)在等效期MRI上明确脑缺氧负荷与脑损伤的关系。2）确定脑缺氧后最常见的干预措施，和3)量化隐匿性脑缺氧事件的频率。
越来越多的证据表明早期脑NIRS监测在早产儿的神经保护护理中的作用。这项第二阶段试验将提供必要的数据，以改善干预方法，对干预措施对更广泛范围的脑损伤的影响大小进行建模，并量化全身和脑缺氧测量值之间的差异。
将招募100名妊娠28周以下的婴儿进行前瞻性研究，多中心干预试验。知情同意后，婴儿将在出生后6小时内开始接受脑NIRS监测,并持续至72小时。患有持续性脑饱和度下降症的婴儿将按照提供者根据患者的临床状况选择的标准治疗算法接受干预.提供者将记录干预的时间和选择，并对幸存者进行术语等效脑MRI。本研究的目标有三个：1)在等效期MRI上明确脑缺氧负荷与脑损伤的关系。2）确定脑缺氧后最常见的干预措施，和3)量化隐匿性脑缺氧事件的频率。
越来越多的证据表明早期脑NIRS监测在早产儿的神经保护护理中的作用。这项第二阶段试验将提供必要的数据，以改善干预方法，对干预措施对更广泛范围的脑损伤的影响大小进行建模，并量化全身和脑缺氧测量值之间的差异。
