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
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|
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
- 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
- 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
- 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
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
|Contact: Mark Underwood, MDfirstname.lastname@example.org|
|Contact: Rosa Pesaventoemail@example.com|
|United States, California|
|UC Davis Medical Center||Recruiting|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Mark Underwood, MD||UC Davis|