A Cohort Study of the Intestinal Microbiota of Premature Infants

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Necrotizing Enterocolitis Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Failure to Thrive Gastroenteritis Gastrointestinal Diseases Growth Failure Infant, Newborn, Diseases Infant, Premature, Diseases Intestinal Diseases Lung Diseases Lung Injury Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Ventilator-Induced Lung Injury

Age range

Up to 33 week

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

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

Inclusion criteria

gestational age < 33 weeks at birth

Exclusion criteria

none

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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
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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2027
Study completion: 2027
First posted: Oct 24, 2018
Registry last updated: Apr 3, 2026

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.

Published trials that share one or more normalized conditions with this study.

Completed