Necrotising EnterocolitisNECNCT04792918
Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
An observational study of Necrotising Enterocolitis and Late-Onset Neonatal Sepsis, run by Emma Marie Caroline Slack at 2 sites in Switzerland.
Trial summary
Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop NEC/LOS. Read more about this study
- Who is it for?
- Ages 0 to 3 days
- Conditions the study is for
- Necrotising Enterocolitis, Late-Onset Neonatal Sepsis
- How many people
- 81 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 11 Feb 2021to 20 Jun 2023
- How long will I take part?
- 4 Weeks
- 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 0 to 3 days
- All sexes
- No healthy volunteers
- Child
Study population: The study population is represented by infants born at gestational age below 32 weeks (very preterm born infants) or with a birthweight below 1500g (very low birthweight infants). It is estimated that approximately 100 infants will be enrolled during the study period. As the aim is to study stability of the premature microbiota within individual patients, the study design precludes the need of control groups.
Who may be able to join
- -Preterm infants with a gestational age < 32 weeks or a birthweight < 1500g and their family members
Who cannot join
- Intestinal atresia
- Live born infants referred to from other hospitals later than 3 days after birth
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Children's Hospital Zürich
Zurich, 8032
University Hospital Zürich
Zurich, 8091
About this study
Official title: Intestinal Microbiome Strain-level Stability in NEC/ or LOS Patients
Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop NEC/LOS.
Read the detailed description
This study aims to collect biological samples (stool, stomach fluid, and blood) from preterm infants at risk of developing NEC or LOS; as well as environmental samples from infants' hospital surroundings (swabs, air), nutritional intake (formula, breastmilk) and samples from their family members (faeces, vaginal swab).
The main focus of the study is to assess strain-level stability of gastrointestinal microbiota in these infants and potentially assess the source of disease-causing microbiota species/strains.
- Medical subject headings
- Enterocolitis, Necrotizing, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NEC/LOS preterm infants | Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life, additional stool samples after onset of NEC/LOS | |
| Preterm infants not developing NEC/LOS | Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life | |
| Family members of preterm infants | Collection of biological samples (stool, breastmilk, vaginal swab) and health-related data at one timepoint after the birth of the preterm infant from members of the family (mother, father) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strain-level stability
Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm infants via changes in frequencies, absolute colonization levels, or temporal stability
Measured: 24 months
Secondary outcomes (1)
Source of bacterial species/strains
Quantify genetic similarity between potentially disease-causing microbiota strains found within NEC/LOS patients and within family members (faeces, breastmilk, vaginal swab) and hospital surroundings
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start11 Feb 2021
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotising EnterocolitisStudies 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
- 81 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Emma Marie Caroline Slack
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, University Children's Hospital, Zurich
- Responsible party
- Sponsor-investigator, Emma Marie Caroline Slack, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792918
- Sponsor's protocol ID
- NEC
- Acronym
- NEC
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2021
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiome Strain-level Stability in NEC/ or LOS Patients
- ClinicalTrials.gov ID
- NCT04792918
- Acronym / sponsor ID
- NEC / NEC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Emma Marie Caroline SlackUniversity, hospital or other
- Collaborators
- University of Zurich, University Children's Hospital, Zurich
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 11 Mar 2021 (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.
Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop NEC/LOS.
Detailed description
This study aims to collect biological samples (stool, stomach fluid, and blood) from preterm infants at risk of developing NEC or LOS; as well as environmental samples from infants' hospital surroundings (swabs, air), nutritional intake (formula, breastmilk) and samples from their family members (faeces, vaginal swab).
The main focus of the study is to assess strain-level stability of gastrointestinal microbiota in these infants and potentially assess the source of disease-causing microbiota species/strains.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NEC/LOS preterm infants | – | –Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life, additional stool samples after onset of NEC/LOS |
| Preterm infants not developing NEC/LOS | – | –Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life |
| Family members of preterm infants | – | –Collection of biological samples (stool, breastmilk, vaginal swab) and health-related data at one timepoint after the birth of the preterm infant from members of the family (mother, father) |
Who may qualify
- Ages
- 0 to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population is represented by infants born at gestational age below 32 weeks (very preterm born infants) or with a birthweight below 1500g (very low birthweight infants). It is estimated that approximately 100 infants will be enrolled during the study period. As the aim is to study stability of the premature microbiota within individual patients, the study design precludes the need of control groups.
Key inclusion criteria (1 listed)
- -Preterm infants with a gestational age < 32 weeks or a birthweight < 1500g and their family members
Key exclusion criteria (2 listed)
- Intestinal atresia
- Live born infants referred to from other hospitals later than 3 days after birth
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
Strain-level stability
Time frame: 24 months
Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm infants via changes in frequencies, absolute colonization levels, or temporal stability
1 secondary outcome
Source of bacterial species/strains
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotising Enterocolitis and Late-Onset Neonatal Sepsis, run by Emma Marie Caroline Slack at 2 sites in Switzerland.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Strain-level stability (time frame: 24 months). 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 10 Jul 2023.