Dynamics of the Microbiome in the Premature Infant

April 11, 2024 updated by: Duke University
The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.

Study Overview

Status

Completed

Conditions

Detailed Description

The study team will collect samples of blood and stool from preterm infants once a week from the first week of life until 8 weeks after delivery. Blood samples will be collected from left over blood that is being collected for clinical management. No extra blood draws will be done for research purposes only. Samples of leftover breast milk will be collected once weekly from the first week of life until 8 weeks after delivery.

While the baby is in the hospital the study team will collect information about the growth and development as well as events that happen during their intensive care nursery (ICN) hospitalization.

In addition, blood and stool will be collected, as well as information about the growth when the infant returns to the Duke Special Infant Care Clinic for developmental check-ups at 6 and 12 months of age. The blood will be approximately 1 teaspoon (5 milliliters) and will be done at the same time that labs for clinical management are being done.

A single maternal blood sample (approximately 2 teaspoons) and stool sample will be collected after delivery. Information will also be collected from the medical record.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 week (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Very low birth weight infants

Description

Inclusion Criteria:

  • 1500 grams or less at birth
  • infants without genetic diseases or gross anomalies
  • mother has to be planning on providing breast milk to the infant

Exclusion Criteria:

  • infants with genetic diseases or gross anomalies
  • parents who are not willing to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
very low birth weight infants
Very low birth weight infants weighing 1500 grams at birth or less

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antigen identification of the infant microbiome over the first year of life
Time Frame: Week 1
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Week 1
antigen identification of the infant microbiome over the first year of life
Time Frame: Week 2
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Week 2
antigen identification of the infant microbiome over the first year of life
Time Frame: Week 3
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Week 3
antigen identification of the infant microbiome over the first year of life
Time Frame: Week 4
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Week 4
antigen identification of the infant microbiome over the first year of life
Time Frame: Week 5
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Week 5
antigen identification of the infant microbiome over the first year of life
Time Frame: Week 6
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Week 6
antigen identification of the infant microbiome over the first year of life
Time Frame: Week 7
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Week 7
antigen identification of the infant microbiome over the first year of life
Time Frame: Week 8
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Week 8
antigen identification of the infant microbiome over the first year of life
Time Frame: 6 months
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
6 months
antigen identification of the infant microbiome over the first year of life
Time Frame: 12 months
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Patrick Seed, MD PhD, Duke Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimated)

April 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00051659

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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