An observational study in Sepsis, Necrotizing Enterocolitis and Chorioamnionitis, sponsored by Per Torp Sangild. Terminated at 1 site in China. Open to participants aged 1 Day to 1 Day, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Per Torp Sangild · Observational
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).
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
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 50 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Per Torp Sangild is the lead sponsor of 5 studies on the registry; none are open to participants now.
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The study recruits very preterm infants (\< 32 weeks of gestation) at the Department of Neonatology, Bao'An maternal and Child Health Hospital right after birth after screening inclusion and exclusion criteria. Information about maternal conditions (premature rupture of membranes or chorioamnionitis) and birth are collected but are not determining factor to recruit.
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Exclusion Criteria:
Circulating markers
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)
Time frame: From birth until 4 weeks of age or until discharge, whichever comes first
Plan to share: Undecided
Ran from Sep 2017 to primary completion in Oct 2019, 25 months.
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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Per Torp Sangild