Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation

Sepsis Clinical Trial

— NEOINFLAM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03320785
• Other study ID #: NEOINFLAM 2017
• Status: Terminated
• Start date: September 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Day

Eligibility

Inclusion Criteria:

• Preterm infants born before the complete 32 weeks of gestation

• Signed parental consent

Exclusion Criteria:

• Major congenital anomalies or birth defects

Related Conditions & MeSH terms

• Chorioamnionitis
• Enterocolitis
• Enterocolitis, Necrotizing
• Feeding Intolerance
• Inflammation
• Necrotizing Enterocolitis
• Sepsis

Locations

Country	Name	City	State
China	Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Per Torp Sangild	Baoan Maternal And Child Health Care Hospital, Shenzhen, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Infants without and with sepsis/NEC.; Infants without and with clinical/histological chorioamnionitis.; Infants receiving different type or amount of milk diets (e.g. mother´s own milk, donor milk, formula, fortifier)	From birth until 4 weeks of age or until discharge, whichever comes first

External Links

•   The current clinical trial is a part of the NEOMUNE project.