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NCT03717584 Clinical Trial

A Cohort Study of the Intestinal Microbiota of Premature Infants

Bronchopulmonary Dysplasia Clinical Trial

Official title:
A Cohort Study of the Intestinal Microbiota of Premature Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03717584
Other study ID # 888501
Secondary ID UCD#888501-3
Status Active, not recruiting
Phase
First received
Last updated
Start date December 23, 2018
Est. completion date December 2026

Study information
Verified date May 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date December 2026
Est. primary completion date December 2023
Accepts healthy volunteers
Gender All
Age group N/A to 33 Weeks
Eligibility Inclusion Criteria: - gestational age < 33 weeks at birth Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (3)

Claud EC, Keegan KP, Brulc JM, Lu L, Bartels D, Glass E, Chang EB, Meyer F, Antonopoulos DA. Bacterial community structure and functional contributions to emergence of health or necrotizing enterocolitis in preterm infants. Microbiome. 2013 Jul 10;1(1):20. doi: 10.1186/2049-2618-1-20. — View Citation

Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available. — View Citation

Mai V, Young CM, Ukhanova M, Wang X, Sun Y, Casella G, Theriaque D, Li N, Sharma R, Hudak M, Neu J. Fecal microbiota in premature infants prior to necrotizing enterocolitis. PLoS One. 2011;6(6):e20647. doi: 10.1371/journal.pone.0020647. Epub 2011 Jun 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnosis of necrotizing enterocolitis 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 Diagnosis of bronchopulmonary dysplasia 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
Secondary Diagnosis of growth failure 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
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