Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation (NEOINFLAM)

March 22, 2022 updated by: Per Torp Sangild

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

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).

Study Overview

Status

Terminated

Conditions

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

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518133
        • Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 day (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Major congenital anomalies or birth defects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating markers
Time Frame: From birth until 4 weeks of age or until discharge, whichever comes first

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Torp Sangild

Collaborators

Baoan Maternal And Child Health Care Hospital, Shenzhen, China

Investigators

  • Study Director: Per T Sangild, PhD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEOINFLAM 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe