Microbial ColonizationNCT05385939
Gastric Bacterial Colonization of Preterm Neonates
An observational study of Microbial Colonization and Preterm Birth, run by Christiana Care Health Services at 1 site in United States.
Trial summary
This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NICU. Read more about this study
- Who is it for?
- Ages 1 week to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Preterm Birth
- What is being tested?
- Observational
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 May 2022
- 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 week to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of infants born at less than 32 weeks born and admitted to the CCHS NICU. Infants in Time period 2 that were admitted to the traditional, open bay NICU will be excluded.
Who may be able to join
- Less than 32 weeks gestation at birth
Who cannot join
- Infants in Time period 2 that were admitted to the traditional, open bay NICU
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Services, Inc.
Newark, Delaware, 19718
About this study
Official title: Impact of Transition to a New Single Patient Room NICU on Gastric Bacterial Colonization of Preterm Neonates Compared to a Traditional Open Bay NICU
This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NICU. There was a 3 month period between Time period 1 and Time period 2 to ensure that there was no patient overlap. Stool samples and environmental samples were collected at 1 and 4 weeks after birth in both time periods. The objective of this study was to establish the gastrointestinal microbiome of infants born at less than 32 weeks gestation admitted to the exiting open bay NICU and compare it to the gastrointestinal microbiome of infants born at less than 32 weeks admitted to the new private, single family room NICU.
- Conditions
- Microbial Colonization, Preterm Birth
- Being tested
- Observational
- Medical subject headings
- Communicable Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This was an observational study which involved collection of stool samples and environmental samples at 1 week and 4 weeks of life.
| Study group | Role | What they receive |
|---|---|---|
| Time period 1 | Time period one included infants admitted to the current traditional, open bay NICU. Receives: Other: Observational | |
| Time period 2 | Time period 2 included infants admitted to the private, single family room NICU. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microorganisms identified in stool samples
Microorganisms identified in stool samples obtained at weeks 1 and 4 of life using the 16s rRNA sequencing based technique.
Measured: 4 weeks
Secondary outcomes (1)
Microorganisms identified in environmental samples
Microorganisms identified in samples obtained from the counter, floor, and incubator top or inside wall at weeks 1 and 4 of life using the 16 s rRNA sequencing based technique.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Apr 2019
- Primary completion31 Oct 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385939
- Sponsor's protocol ID
- Christiana Care Health System
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 23 May 2022
- 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 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transition to a New Single Patient Room NICU on Gastric Bacterial Colonization of Preterm Neonates Compared to a Traditional Open Bay NICU
- ClinicalTrials.gov ID
- NCT05385939
- Acronym / sponsor ID
- Christiana Care Health System
- Conditions
- Microbial Colonization, Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 23 May 2022 (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.
This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NICU. There was a 3 month period between Time period 1 and Time period 2 to ensure that there was no patient overlap. Stool samples and environmental samples were collected at 1 and 4 weeks after birth in both time periods. The objective of this study was to establish the gastrointestinal microbiome of infants born at less than 32 weeks gestation admitted to the exiting open bay NICU and compare it to the gastrointestinal microbiome of infants born at less than 32 weeks admitted to the new private, single family room NICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time period 1 | – | Other: ObservationalTime period one included infants admitted to the current traditional, open bay NICU. |
| Time period 2 | – | Other: ObservationalTime period 2 included infants admitted to the private, single family room NICU. |
Who may qualify
- Ages
- 1 week to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of infants born at less than 32 weeks born and admitted to the CCHS NICU. Infants in Time period 2 that were admitted to the traditional, open bay NICU will be excluded.
Key inclusion criteria (1 listed)
- Less than 32 weeks gestation at birth
Key exclusion criteria (1 listed)
- Infants in Time period 2 that were admitted to the traditional, open bay NICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThis was an observational study which involved collection of stool samples and environmental samples at 1 week and 4 weeks of life. | Other | Time period 1, Time period 2 |
Primary outcome
Microorganisms identified in stool samples
Time frame: 4 weeks
Microorganisms identified in stool samples obtained at weeks 1 and 4 of life using the 16s rRNA sequencing based technique.
1 secondary outcome
Microorganisms identified in environmental samples
Time frame: 4 weeks
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 23 May 2022.
- 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.
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 Microbial Colonization and Preterm Birth, run by Christiana Care Health Services at 1 site in United States.
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 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: finished, as of the sponsor's last update on 23 May 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 United States. 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?
Microorganisms identified in stool samples (time frame: 4 weeks). 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 May 2022.