A Cohort Study of the Intestinal Microbiota of Premature Infants

Active, not recruiting

• Conditions: Necrotizing Enterocolitis; Bronchopulmonary Dysplasia; Growth Failure

• Registration Number: NCT03717584
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-24
• Study Start: 2018-12-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2027-03-05
• Study Completion: 2027-03-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• gestational age < 33 weeks at birth

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of necrotizing enterocolitis	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 Outcome Measures

Name	Time	Method
Diagnosis of growth failure	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
Diagnosis of bronchopulmonary dysplasia	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

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States