Zhang Yahui, Zhu Weiwei, Du Qing, Chen Lingli, Huang Jianqiu, Liu Yunfeng
Department of Pediatrics, Peking University Third Hospital, NO. 49,Hua Yuan Bei Lu, Hai Dian District, Beijing, 100191, P. R. China.
BMC Pediatr. 2025 Aug 28;25(1):659. doi: 10.1186/s12887-025-05946-5.
Most preterm infants with a gestational age < 32 weeks in the neonatal intensive care unit (NICU) undergo blood transfusion therapy during their hospital stay to enhance their oxygen-carrying capacity and improve the oxygenation of vital organs. However, anemia and blood transfusions can lead to intestinal damage. Bedside abdominal ultrasonography and near-infrared spectroscopy (NIRS) are widely applied to monitor intestinal injury and oxygen perfusion. We hypothesized that in preterm infants (gestational age < 32 weeks) with anemia and indications for transfusion, signs of intestinal injury detected by abdominal ultrasound and NIRS may appear earlier than clinical symptoms, signs, and other auxiliary examinations. Herein, we present the protocol of a study designed to assess whether abdominal ultrasonography and NIRS could therefore improve the timeliness, sensitivity, and accuracy of intestinal injury diagnosis, thereby improving prognosis.
This prospective observational study will enroll infants with a gestational age between 23 + 0 and 31 + 6 weeks with neonatal anemia, who meet the criteria for blood transfusion, and scheduled to receive transfusion therapy. In addition to routine clinical symptoms, signs, and other auxiliary examination monitoring during the transfusion process, abdominal ultrasound and NIRS findings will be analyzed. The primary outcome is the prediction intestinal injury related to anemia/transfusion using ultrasound and NIRS. A sample size of 100 cases has been set.
The etiology of transfusion-associated neonatal enterocolitis (TANEC) remains unclear and may result from multiple factors. Several prospective studies have assessed the significance and advantages of abdominal ultrasound combined with NIRS for monitoring intestinal injury in anemic states and transfusion therapy. Therefore, this trial aims to test the following hypothesis: monitoring intestinal injury in preterm infants (gestational age < 32 weeks) with anemia receiving red blood cell transfusions using abdominal ultrasound and NIRS can provide real-time information on changes in intestinal oxygenation during transfusion, to identify specific signs and trends in the digestive system prior to clinical symptoms and other auxiliary examination methods, thereby guiding and adjusting clinical decisions more accurately, sensitively, and rapidly. If the hypothesis is confirmed, this monitoring approach might provide a basis for early interventions to mitigate intestinal injury risks.
ClinicalTrials.gov ID: NCT06857812
The online version contains supplementary material available at 10.1186/s12887-025-05946-5.
大多数入住新生儿重症监护病房（NICU）的孕周＜32周的早产儿在住院期间会接受输血治疗，以提高其携氧能力并改善重要器官的氧合。然而，贫血和输血会导致肠道损伤。床旁腹部超声检查和近红外光谱（NIRS）被广泛应用于监测肠道损伤和氧灌注。我们推测，在患有贫血且有输血指征的早产儿（孕周＜32周）中，腹部超声和NIRS检测到的肠道损伤迹象可能比临床症状、体征及其他辅助检查出现得更早。在此，我们展示一项研究方案，旨在评估腹部超声和NIRS是否因此可以提高肠道损伤诊断的及时性、敏感性和准确性，从而改善预后。
这项前瞻性观察性研究将纳入孕周在23⁺⁰至31⁺⁶周之间、患有新生儿贫血、符合输血标准且计划接受输血治疗的婴儿。在输血过程中，除了常规临床症状、体征及其他辅助检查监测外，还将分析腹部超声和NIRS的检查结果。主要结局是使用超声和NIRS预测与贫血/输血相关的肠道损伤。已设定样本量为100例。
输血相关新生儿坏死性小肠结肠炎（TANEC）的病因仍不清楚，可能由多种因素导致。几项前瞻性研究评估了腹部超声联合NIRS在监测贫血状态和输血治疗中肠道损伤的意义和优势。因此，本试验旨在检验以下假设：使用腹部超声和NIRS监测接受红细胞输血的贫血早产儿（孕周＜32周）的肠道损伤，可以提供输血期间肠道氧合变化的实时信息，在临床症状和其他辅助检查方法出现之前识别消化系统的特定体征和趋势，从而更准确、敏感和迅速地指导和调整临床决策。如果该假设得到证实，这种监测方法可能为减轻肠道损伤风险的早期干预提供依据。
ClinicalTrials.gov标识符：NCT06857812
在线版本包含可在10.1186/s12887 - 025 - 05946 - 5获取的补充材料。
