Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation

NCT ID: NCT03320785

Last Updated: 2022-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Sepsis Necrotizing Enterocolitis Chorioamnionitis Feeding Intolerance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Major congenital anomalies or birth defects
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baoan Maternal And Child Health Care Hospital, Shenzhen, China

UNKNOWN

Sponsor Role collaborator

Per Torp Sangild

OTHER

Sponsor Role lead

Responsible Party

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Per Torp Sangild

Professor, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Per T Sangild, PhD

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

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Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)

Shenzhen, Guangdong, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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http://neomune.ku.dk/

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

Other Identifiers

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NEOINFLAM 2017

Identifier Type: -

Identifier Source: org_study_id

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