Gastric Bacterial Colonization of Preterm Neonates

Completed

• Conditions: Preterm Birth; Microbial Colonization
• Interventions: Other: Observational

• Registration Number: NCT05385939
• Lead Sponsor: Christiana Care Health Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2021-10-31
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Last Update Submitted: 2022-05-18
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Less than 32 weeks gestation at birth

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Exclusion Criteria

• Infants in Time period 2 that were admitted to the traditional, open bay NICU

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Time period 1	Observational	Time period one included infants admitted to the current traditional, open bay NICU.
Time period 2	Observational	Time period 2 included infants admitted to the private, single family room NICU.

Primary Outcome Measures

Name	Time	Method
Microorganisms identified in stool samples	4 weeks	Microorganisms identified in stool samples obtained at weeks 1 and 4 of life using the 16s rRNA sequencing based technique.

Secondary Outcome Measures

Name	Time	Method
Microorganisms identified in environmental samples	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.

Trial Locations

Locations (1)

Christiana Care Health Services, Inc.; 🇺🇸 Newark, Delaware, United States