NCT03320785

Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation

Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation: An Observational Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Per Torp Sangild · Academic / Other
• Sex: All
• Age: 1 Day – 1 Day
• Healthy volunteers: Accepted

Summary

Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset. The investigators plan to collect weekly blood samples of preterm infants from birth until 4 weeks of age to comprehensively characterize differential protein and epigenetic markers in infants with and without complications (sepsis, necrotizing enterocolitis, chorioamnionitis).

Detailed description

Preterm infants (10% incidence worldwide), especially those who do not receive sufficient mother's own milk, are susceptible to infectious diseases including sepsis and necrotizing enterocolitis. Infants with history of prenatal inflammation including chorioamnionitis may be at higher risks of acquiring these infectious diseases. Limited knowledge is available regarding a comprehensive temporal profile of circulating markers in preterm infants from birth to disease onset. This current study aims to provide a comprehensive temporal profile of circulating markers, via -omic techniques (proteomics and/or epigenetics), during the first 4 weeks of life in preterm infants with various systemic complications. Thus, this will elucidate a profile of early markers consistently associated with pathological conditions in the whole study period. Depending on the outcome, a subsequent study for validation may be performed. Primary objective: To characterize circulating markers associated with the early life complications including chorioamnionitis, LOS and NEC in preterm infants during the first four weeks of life. Secondary objective: To characterize how different feeding regimes and diets may affect these markers during the first four weeks of life in preterm infants

Conditions

• Sepsis
• Necrotizing Enterocolitis
• Chorioamnionitis
• Feeding Intolerance

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-10-01
• Completion: 2021-12-31
• First posted: 2017-10-25
• Last updated: 2022-03-23

Locations

1 site across 1 country: China