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
Launched by PEKING UNIVERSITY THIRD HOSPITAL · Feb 27, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial aims to explore how well ultrasound and a special light technique called near-infrared spectroscopy (NIRS) can help detect intestinal injury in very premature infants (those born before 32 weeks of pregnancy) who need blood transfusions due to anemia. Blood transfusions can sometimes cause harm to the intestines, and this study hopes to find out if using these two monitoring methods can spot problems earlier than other signs or tests. By doing so, the researchers believe they can help doctors make better decisions, potentially improving the health and survival of these fragile infants.
To participate in the study, infants must be between 23 and 31 weeks old, hospitalized in the neonatal intensive care unit (NICU), and scheduled for a blood transfusion. Parents will need to provide written consent for their child to take part. During the study, doctors will use ultrasound and NIRS alongside standard monitoring to keep an eye on the infants' intestinal health during the transfusion. This research is important as it could lead to better outcomes for very premature infants facing the risks of blood transfusions.
Gender
ALL
Eligibility criteria
- 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.
About Peking University Third Hospital
Peking University Third Hospital is a leading medical institution in China, renowned for its commitment to advanced healthcare, innovative research, and comprehensive clinical services. As a prominent sponsor of clinical trials, the hospital emphasizes the integration of cutting-edge scientific research with patient-centered care to enhance therapeutic outcomes. With a multidisciplinary approach, the institution fosters collaboration among top-tier medical professionals and researchers, striving to contribute to the global medical community through rigorous clinical studies that address pressing health challenges. Its dedication to ethical standards and regulatory compliance ensures the safety and efficacy of new treatments, ultimately aiming to improve patient care and outcomes on both a national and international scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported