Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry
Launched by AIN SHAMS UNIVERSITY · Mar 8, 2025
Trial Information
Current as of July 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how to better predict a serious condition called necrotizing enterocolitis (NEC) in premature babies who have trouble feeding. NEC can be a dangerous problem where the intestines become inflamed and can lead to severe complications. Researchers want to see if using two tools—fecal lipocalin-2, a substance found in stool that may indicate inflammation, and electrical cardiometry, a non-invasive method to measure heart function—can help identify which babies are at risk for developing NEC early on.
To participate in this study, babies must be preterm, born at 35 weeks of pregnancy or earlier, and currently receiving feeding in the neonatal intensive care unit (NICU). They should also have been diagnosed with feeding intolerance, which means they are having difficulty processing their food. However, babies with certain conditions, such as genetic abnormalities or specific intestinal problems, will not be included in this trial. If eligible, participants can expect to undergo some simple tests to help gather information about their health, and their progress will be monitored closely throughout the study. This research aims to improve care for vulnerable preterm infants by finding better ways to predict and manage NEC.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Preterm neonates with gestational age ≤ 35 weeks, admitted to NICU, started enteral feeding and diagnosed as having feeding intolerance defined as stage IA and IB by modified bell's staging
- Exclusion Criteria:
- • 1. Chromosomal anomaly or multiple congenital malformations.
- • 2. Patient with surgical malformation of the intestinal tract (i.e. omphalocele, gastroschisis, malrotation, intestinal atresia)
- • 3. Patient diagnosed as hypoxic ischemic encephalopathy.
About Ain Shams University
Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, Abbasia, Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported