Gastric Bacterial Colonization of Preterm Neonates

NCT05385939 | Completed

• 1 other identifier: Christiana Care Health System
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microorganisms identified in environmental samples

  4 weeks

Study Arms (2)

Time period 1

Time period one included infants admitted to the current traditional, open bay NICU.

Other: Observational

Time period 2

Time period 2 included infants admitted to the private, single family room NICU.

Other: Observational

Interventions

Observational OTHER

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

Time period 1; Time period 2

Eligibility Criteria

• Age: 1 Week - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of infants born at less than 32 weeks born and admitted to the CCHS NICU. Infants in Time period 2 that were admitted to the traditional, open bay NICU will be excluded.

You may qualify if:

• Less than 32 weeks gestation at birth

You may not qualify if:

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

Sponsors & Collaborators

• Christiana Care Health Services: lead
• University of Delaware: collaborator

Study Sites (1)

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Communicable Diseases; Premature Birth

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: April 1, 2019
• Primary Completion: October 31, 2021
• Study Completion: May 1, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)