Gastric Bacterial Colonization of Preterm Neonates
May 18, 2022 updated by: Christiana Care Health Services
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
122
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
-
-
Delaware
-
Newark, Delaware, United States, 19718
- Christiana Care Health Services, Inc.
-
-
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 week to 6 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Less than 32 weeks gestation at birth
Exclusion Criteria:
- Infants in Time period 2 that were admitted to the traditional, open bay NICU
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Time period 1
Time period one included infants admitted to the current traditional, open bay NICU.
|
This was an observational study which involved collection of stool samples and environmental samples at 1 week and 4 weeks of life.
|
|
Time period 2
Time period 2 included infants admitted to the private, single family room NICU.
|
This was an observational study which involved collection of stool samples and environmental samples at 1 week and 4 weeks of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microorganisms identified in environmental samples
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
April 1, 2019
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
May 18, 2022
First Submitted That Met QC Criteria
May 18, 2022
First Posted (Actual)
May 23, 2022
Study Record Updates
Last Update Posted (Actual)
May 23, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Christiana Care Health System
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.