Clinical trial NCT03320785: Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Official title: Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation: An Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sepsis
Necrotizing Enterocolitis
Chorioamnionitis
Feeding Intolerance
Keywords: preterm infants
sepsis
chorioamnionitis
circulating markers
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Baoan Maternal And Child Health Care Hospital, Shenzhen, China
First posted: 2017-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Major congenital anomalies or birth defects

Primary outcomes:
measure: Circulating markers
timeFrame: From birth until 4 weeks of age or until discharge, whichever comes first
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)
state: Guangdong
Study officials:
affiliation: Rigshospitalet, Denmark
name: Per T Sangild, PhD
role: STUDY_DIRECTOR
References: