Gastric Bacterial Colonization of Preterm Neonates

NCT05385939 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2022-05-23

No results posted yet for this study

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

OTHER

Observational

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

Sponsors & Collaborators

  • University of Delaware

    collaborator OTHER
  • Christiana Care Health Services

    lead OTHER

Eligibility

Min Age
1 Week
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-10-31
Completion
2022-05-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385939 on ClinicalTrials.gov