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A Cohort Study of the Intestinal Microbiota of Premature Infants

A Cohort Study of the Intestinal Microbiota of Premature Infants

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03717584
Enrollment
300
Registered
2018-10-24
Start date
2018-12-23
Completion date
2027-03-05
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia, Growth Failure, Necrotizing Enterocolitis

Keywords

microbiota, metabolome, lipidome

Brief summary

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.

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.

Interventions

None listed

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 33 Weeks

Inclusion criteria

* gestational age \< 33 weeks at birth

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of necrotizing enterocolitisup 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

Secondary

MeasureTime frameDescription
Diagnosis of bronchopulmonary dysplasiaup to 20 weeks, from the time of enrollment until the time of discharge from the NICUHow many infants in the cohort develop mild, moderate, or severe bronchopulmonary dysplasia based on the criteria outlined by Jobe in 2001
Diagnosis of growth failureup to 20 weeks, from the time of enrollment until the time of discharge from the NICUHow 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMark Underwood, MD

UC Davis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026