Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared SpectroscopyNCT06857812
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
An observational study of Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared Spectroscopy, run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared Spectroscopy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2025to May 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 100
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
- Being tested
- there is no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionOther
there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Ultrasound Monitoring
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).
Measured: 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 outcomes (1)
NIRS monitoring
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start24 Feb 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared SpectroscopyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857812
- Sponsor's protocol ID
- M2024531
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhang Y, Zhu W, Du Q, Chen L, Huang J, Liu Y. 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. BMC Pediatr. 2025 Aug 28;25(1):659. doi: 10.1186/s12887-025-05946-5.
PubMed 40866894
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06857812
- Acronym / sponsor ID
- M2024531
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremely preterm infants | – | Other: there is no interventionThis 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 |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 100
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no interventionthere is no intervention | Other | Extremely preterm infants |
Primary outcome
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).
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 40866894Zhang Y, Zhu W, Du Q, Chen L, Huang J, Liu Y. 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. BMC Pediatr. 2025 Aug 28;25(1):659. doi: 10.1186/s12887-025-05946-5.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared Spectroscopy, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu yunfeng Chief Physician (+86 18811796984, yeshangwuzhebang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.