SepsisNEOINFLAMNCT03320785
Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
An observational study of Sepsis and Necrotizing Enterocolitis, run by Per Torp Sangild at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Necrotizing Enterocolitis, Chorioamnionitis
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Preterm infants born before the complete 32 weeks of gestation
- Signed parental consent
Who cannot join
- Major congenital anomalies or birth defects
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)
Shenzhen, Guangdong, 518133
About this study
Official title: 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).
Read the 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
- Keywords
- preterm infants, sepsis, chorioamnionitis, circulating markers
- Medical subject headings
- Sepsis, Enterocolitis, Necrotizing, Chorioamnionitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From birth until 4 weeks of age or until discharge, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Oct 2019
- Study completion31 Dec 2021
Why it stopped: Principal Investigator unable to incorporate study and recruitments into clinical routines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Torp Sangild
- Sponsor type
- University, hospital or other
- Collaborators
- Baoan Maternal And Child Health Care Hospital, Shenzhen, China
- Responsible party
- Sponsor-investigator, Per Torp Sangild, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Per T Sangild, PhD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320785
- Sponsor's protocol ID
- NEOINFLAM 2017
- Acronym
- NEOINFLAM
- Status last verified
- Mar 2022
- First submitted
- 13 Oct 2017
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation: An Observational Study
- ClinicalTrials.gov ID
- NCT03320785
- Acronym / sponsor ID
- NEOINFLAM / NEOINFLAM 2017
- Keywords
- preterm infants, sepsis, chorioamnionitis, circulating markers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator unable to incorporate study and recruitments into clinical routines
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Per Torp SangildUniversity, hospital or other
- Collaborators
- Baoan Maternal And Child Health Care Hospital, Shenzhen, China
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Preterm infants born before the complete 32 weeks of gestation
- Signed parental consent
Key exclusion criteria (1 listed)
- Major congenital anomalies or birth defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study was stopped early (reason given: Principal Investigator unable to incorporate study and recruitments into clinical routines). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- The current clinical trial is a part of the NEOMUNE project.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per T Sangild, PhD study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Necrotizing Enterocolitis, run by Per Torp Sangild at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator unable to incorporate study and recruitments into clinical routines). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating markers (time frame: From birth until 4 weeks of age or until discharge, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.