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Gastric Bacterial Colonization of Preterm Neonates

Impact of Transition to a New Single Patient Room NICU on Gastric Bacterial Colonization of Preterm Neonates Compared to a Traditional Open Bay NICU

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05385939
Enrollment
122
Registered
2022-05-23
Start date
2019-04-01
Completion date
2022-05-01
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization, Preterm Birth

Brief 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. 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.

Interventions

OTHERObservational

This was an observational study which involved collection of stool samples and environmental samples at 1 week and 4 weeks of life.

Sponsors

University of Delaware
CollaboratorOTHER
Christiana Care Health Services
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 6 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Microorganisms identified in stool samples4 weeksMicroorganisms identified in stool samples obtained at weeks 1 and 4 of life using the 16s rRNA sequencing based technique.

Secondary

MeasureTime frameDescription
Microorganisms identified in environmental samples4 weeksMicroorganisms 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026