Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation

Terminated

• Conditions: Feeding Intolerance; Sepsis; Necrotizing Enterocolitis; Chorioamnionitis

• Registration Number: NCT03320785
• Lead Sponsor: Per Torp Sangild

Brief 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

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Primary Completion: 2019-10-01
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Preterm infants born before the complete 32 weeks of gestation
• Signed parental consent

Exclusion Criteria

• Major congenital anomalies or birth defects

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulating markers	From birth until 4 weeks of age or until discharge, whichever comes first	Temporal profile of circulating markers are characterized from weekly collected blood samples (from birth until 4 weeks of age or until discharge, whichever comes first). Profiles are compared between: 1. Infants without and with sepsis/NEC.; 2. Infants without and with clinical/histological chorioamnionitis.; 3. Infants receiving different type or amount of milk diets (e.g. mother´s own milk, donor milk, formula, fortifier)

Trial Locations

Locations (1)

Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH); 🇨🇳 Shenzhen, Guangdong, China