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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Liu yunfeng Chief Physician
- Phone Number: +86 18811796984
- Email: yeshangwuzhebang@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1. preterm infants with a gestational age between 23+0 and 31+6 weeks, 2. infants hospitalized in our hospital's NICU after birth, receiving a blood transfusion during hospitalization; and 3. infants whose parents provide written informed consent.
Exclusion Criteria:
- 1. Presence of severe congenital malformations or chromosomal abnormalities, 2. anemia due to acute blood loss; 3. presence of severe hemodynamic disorders, coagulation dysfunction, and disseminated intravascular coagulation (DIC); 4. presence of neonatal necrotizing enterocolitis, sepsis, or severe infectious conditions such as septicemia that remain uncorrected before transfusion; 5. congenital hematological diseases (such as pure red cell aplasia); 6. death due to other complications; 7. incomplete data; 8. infants participating in other interventional studies; and 8. infants whose parents do not consent to their participation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Extremely preterm infants
This study is an observational study with no interventions. Inclusion Criteria: 1. preterm infants with a gestational age between 23+0 and 31+6 weeks. 2. infants hospitalized in our hospital's NICU after birth, receiving a blood transfusion during hospitalization. 3. infants whose parents provide written informed consent. Exclusion Criteria: 1. Presence of severe congenital malformations or chromosomal abnormalities, 2. anemia due to acute blood loss; 3. presence of severe hemodynamic disorders, coagulation dysfunction, and disseminated intravascular coagulation (DIC); 4. presence of neonatal necrotizing enterocolitis, sepsis, or severe infectious conditions such as septicemia that remain uncorrected before transfusion; 5. congenital hematological diseases (such as pure red cell aplasia); 6. death due to other complications; 7. incomplete data; 8. infants participating in other interventional studies |
there is no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abdominal Ultrasound Monitoring
Time Frame: abdominal ultrasound is assessed before transfusion(baseline measurement), and follow-up after transfusion Hour 0,Hour 1, Hour 2-4, Hour 6, Hour 12 , Day 1, Day 2 and Day 3.
|
The infants will undergo abdominal ultrasound monitoring at fixed time points before and after transfusion.
The main monitoring indicators will include the portal vein, intestinal wall structure, intestinal wall thickness, bowel width, interloop distances, bowel motility, abdominal effusion, and flow velocity/resistance index (RI) of the superior mesenteric artery (SMA).
|
abdominal ultrasound is assessed before transfusion(baseline measurement), and follow-up after transfusion Hour 0,Hour 1, Hour 2-4, Hour 6, Hour 12 , Day 1, Day 2 and Day 3.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NIRS monitoring
Time Frame: NIRS is assessed before transfusion(baseline measurement), and follow-up after transfusion Hour 0,Hour 1, Hour 2-4, Hour 6, Hour 12 , Day 1, Day 2 and Day 3.
|
Owing to the thinness and excellent penetration of the neonatal abdominal wall, the abdominal bowel oxygen saturation (regional oxygen saturation, rSO2) can be monitored using NIRS.
This represents the "weighted average" of the arterial and venous partial oxygen saturation of hemoglobin in tissues approximately 1 to 2 cm deep under the sensor.
The specific method is as follows: the infant is placed in a supine position, and the probe is fixed on the body surface 0.5 to 1.0 cm below the umbilicus.
Except for physical examination and completion of X-ray photography, during which the probe must be removed, intestinal rSO2 will be continuously monitored using the NIRS monitor.
|
NIRS is assessed before transfusion(baseline measurement), and follow-up after transfusion Hour 0,Hour 1, Hour 2-4, Hour 6, Hour 12 , Day 1, Day 2 and Day 3.
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
clinical signs and symptoms
Time Frame: all assessed before transfusion(baseline measurement), and follow-up after transfusion Hour 0,Hour 1, Hour 2-4, Hour 6, Hour 12 , Day 1, Day 2 and Day 3.
|
all assessed before transfusion(baseline measurement), and follow-up after transfusion Hour 0,Hour 1, Hour 2-4, Hour 6, Hour 12 , Day 1, Day 2 and Day 3.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2024531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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