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Significance of Ultrasound Combined with Near-Infrared Spectroscopy in Monitoring Transfusion-Associated Intestinal Injury in Extremely Preterm Infants: a Study Protocol for a Prospective, Observational Study

NCT06857812 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-03-04

No results posted yet for this study

Summary

Background: 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.

Methods: 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.

Conclusion: 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. Thus, monitoring could reduce or prevent the occurrence and progression of intestinal injury, thereby improving long-term survival and prognosis.

Conditions

  • Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared Spectroscopy

Interventions

OTHER

there is no intervention

there is no intervention

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Eligibility

Min Age
23 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2026-02-28
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857812 on ClinicalTrials.gov