A Cohort Study of the Intestinal Microbiota of Premature Infants

May 9, 2023 updated by: University of California, Davis

Premature infants are at risk for a variety of diseases, the investigators would like to learn more about why some premature babies are at higher risk and some are protected from these diseases.

Scientists at UC Davis and other universities have developed new ways to measure the bacteria and a large number of small molecules in specimens of infant blood, urine, stomach fluid and poop and in mother's milk. These discoveries allow us to consider questions that were impossible to answer before these new techniques were developed. One such question is whether the bacteria in the poop of a premature baby can help us predict the baby's risk for developing infection or a common and serious disease of premature infants called necrotizing enterocolitis. A second question is whether the DNA of a premature baby (obtained from saliva with a q-tip) can predict higher risk for diseases of premature babies.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Samples from eligible infants will be collected and stored for future comparisons. These samples include stool specimens from a messy diaper twice weekly, urine samples from cotton balls in the diaper once weekly, a small sample of stomach fluid once a week just prior to a feeding obtained through the feeding tube, a sample of mom's milk once a week, left-over blood from lab draws, and a sample of saliva on one occasion.

The analysis of key specimens from this cohort will allow us to study the impact of the bacteria in the intestines on outcomes like growth and common diseases of premature infants.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center

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

No older than 8 months (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All mothers in preterm labor in the labor and delivery ward for whom a consultation by the neonatology group is requested will be screened for eligibility. All premature infants admitted to the NICU will be screened for eligibility.

Description

Inclusion Criteria:

  • gestational age < 33 weeks at birth

Exclusion Criteria:

  • none

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of necrotizing enterocolitis
Time Frame: up to 20 weeks, from the time of enrollment until the time of discharge from the neonatal intensive care unit (NICU)
How many infants in the cohort develop stage 2 or stage 3 necrotizing enterocolitis by Bells modified criteria
up to 20 weeks, from the time of enrollment until the time of discharge from the neonatal intensive care unit (NICU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of bronchopulmonary dysplasia
Time Frame: up to 20 weeks, from the time of enrollment until the time of discharge from the NICU
How many infants in the cohort develop mild, moderate, or severe bronchopulmonary dysplasia based on the criteria outlined by Jobe in 2001
up to 20 weeks, from the time of enrollment until the time of discharge from the NICU
Diagnosis of growth failure
Time Frame: up to 20 weeks, from the time of enrollment until the time of discharge from the NICU
How many infants in the cohort demonstrate growth failure as defined by a decrease in weight z score by greater than 1 from day of life 7 to day of discharge. Outcome neutral language does not apply here as we are focusing on those infants with poor growth compared to infants with normal or excessive growth
up to 20 weeks, from the time of enrollment until the time of discharge from the NICU

Collaborators and Investigators

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

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Mark Underwood, MD, UC Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

December 23, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 888501
  • UCD#888501-3 (Other Identifier: UC Davis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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