Clinical trial NCT03717584: A Cohort Study of the Intestinal Microbiota of Premature Infants
Official title: A Cohort Study of the Intestinal Microbiota of Premature Infants
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Necrotizing Enterocolitis
Bronchopulmonary Dysplasia
Growth Failure
Keywords: microbiota
metabolome
lipidome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 300
Sex: ALL
Maximum age (years): 33
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* gestational age \< 33 weeks at birth

Exclusion Criteria:

* none

Primary outcomes:
measure: Diagnosis of necrotizing enterocolitis
timeFrame: up to 20 weeks, from the time of enrollment until the time of discharge from the neonatal intensive care unit (NICU)
Secondary outcomes:
measure: Diagnosis of bronchopulmonary dysplasia
timeFrame: up to 20 weeks, from the time of enrollment until the time of discharge from the NICU
measure: Diagnosis of growth failure
timeFrame: up to 20 weeks, from the time of enrollment until the time of discharge from the NICU
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis
name: Mark Underwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: Larke JA, Kuhn-Riordon K, Taft DH, Sohn K, Iqbal S, Underwood MA, Mills DA, Slupsky CM. Preterm Infant Fecal Microbiota and Metabolite Profiles Are Modulated in a Probiotic Specific Manner. J Pediatr Gastroenterol Nutr. 2022 Oct 1;75(4):535-542. doi: 10.1097/MPG.0000000000003570. Epub 2022 Jul 25.