Gastric Bacterial Colonization of Preterm Neonates

Preterm Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385939
• Other study ID #: Christiana Care Health System
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 1, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization
• Premature Birth
• Preterm Birth

Intervention

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

Locations

Country	Name	City	State
United States	Christiana Care Health Services, Inc.	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	4 weeks