Clinical Trials Directory

Trials / Completed

CompletedNCT05385939

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
Phase
Study type
Observational
Enrollment
122 (actual)
Sponsor
Christiana Care Health Services · Academic / Other
Sex
All
Age
1 Week – 6 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

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

Timeline

Start date
2019-04-01
Primary completion
2021-10-31
Completion
2022-05-01
First posted
2022-05-23
Last updated
2022-05-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05385939. Inclusion in this directory is not an endorsement.