A Cohort Study of the Intestinal Microbiota of Premature Infants

• ClinicalTrials.gov Identifier: NCT03717584
• Recruitment Status: Active, not recruiting
• First Posted: October 24, 2018
• Last Update Posted: May 10, 2023
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Study Description

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.

Condition or disease
Necrotizing Enterocolitis; Bronchopulmonary Dysplasia; Growth Failure

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 Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Cohort Study of the Intestinal Microbiota of Premature Infants
• Actual Study Start Date: December 23, 2018
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2026

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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
2. 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

Biospecimen Retention:   Samples With DNA

Infant blood, urine,saliva, stomach fluid, poop, and mother's milk

Eligibility Criteria

• Ages Eligible for Study: up to 33 Weeks (Child)
• Sexes Eligible for Study: All
• 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.

Criteria

Inclusion Criteria:

• gestational age < 33 weeks at birth

Exclusion Criteria:

• none

Contacts and Locations

Locations

United States, California

UC Davis Medical Center

Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Investigators

• Principal Investigator: Mark Underwood, MD; UC Davis

More Information

Additional Information:

Learn more or sign up for the study here! 

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03717584
• Other Study ID Numbers: 888501; UCD#888501-3 ( Other Identifier: UC Davis )
• First Posted: October 24, 2018
• Last Update Posted: May 10, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:

microbiota; metabolome; lipidome

Additional relevant MeSH terms:

Enterocolitis; Enterocolitis, Necrotizing; Bronchopulmonary Dysplasia; Failure to Thrive; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases