Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation

NCT03320785 | Terminated

• 1 other identifier: NEOINFLAM 2017
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis; Necrotizing Enterocolitis; Chorioamnionitis; Feeding Intolerance

Keywords

preterm infants; sepsis; chorioamnionitis; circulating markers

Outcome Measures

Primary Outcomes (1)

• 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)

  From birth until 4 weeks of age or until discharge, whichever comes first

Eligibility Criteria

• Age: 1 Day - 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Major congenital anomalies or birth defects

Sponsors & Collaborators

• Per Torp Sangild: lead
• Baoan Maternal And Child Health Care Hospital, Shenzhen, China: collaborator

Study Sites (1)

Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)

Shenzhen, Guangdong, 518133, China

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Frozen whole blood and plasma.

MeSH Terms

Conditions

Sepsis; Enterocolitis, Necrotizing; Chorioamnionitis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Per T Sangild, PhD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 25, 2017
• Study Start: September 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

CN (1)