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Completed

NCT Number: NCT05385939

Gastric Bacterial Colonization of Preterm Neonates

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Female Urogenital Diseases and Pregnancy Complications Infections Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

1 week–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

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

Primary outcomes

  1. Microorganisms identified in stool samples

    Time frame: 4 weeks

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

Secondary outcomes

  1. Microorganisms identified in environmental samples

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • University of Delaware

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 23, 2022
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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