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A Cohort Study of the Intestinal Microbiota of Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717584
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.


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.

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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





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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717584


Contacts
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Contact: Mark Underwood, MD 916-703-3050 munderwood@ucdavis.edu
Contact: Rosa Pesavento 916-734-8121 rpesavento@ucdavis.edu

Locations
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United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Mark Underwood, MD UC Davis

Publications:
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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    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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
Signs and Symptoms