NCT03717584

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Dec 2018Mar 2027

First Submitted

Initial submission to the registry

July 10, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 23, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2027

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

8.2 years

First QC Date

July 10, 2018

Last Update Submit

March 26, 2025

Conditions

Necrotizing EnterocolitisBronchopulmonary DysplasiaGrowth Failure

Keywords

microbiotametabolomelipidome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Diagnosis of bronchopulmonary dysplasia

    up to 20 weeks, from the time of enrollment until the time of discharge from the NICU

  • Diagnosis of growth failure

    up to 20 weeks, from the time of enrollment until the time of discharge from the NICU

Eligibility Criteria

AgeUp to 33 Weeks
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • gestational age \< 33 weeks at birth

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (4)

  • 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.

    PMID: 21674011BACKGROUND

  • 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.

    PMID: 24450928BACKGROUND

  • 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.

    PMID: 11401896BACKGROUND

  • 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.

    PMID: 35881967DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Enterocolitis, NecrotizingBronchopulmonary DysplasiaFailure to Thrive

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Underwood, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

October 24, 2018

Study Start

December 23, 2018

Primary Completion (Estimated)

March 5, 2027

Study Completion (Estimated)

March 5, 2027

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)