Status:
COMPLETED
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
Lead Sponsor:
University of Tennessee
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
Up to 7 years
Brief Summary
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants. Specifically, t...
Eligibility Criteria
Inclusion
- Newborn humans less than 1 week of age with a birthweight less than 1,500 g, or fetuses with impending delivery and estimated birthweight of less than 1,500 grams. No individuals will be excluded on the basis of sex or ethnicity.
- Parents can understand and comply with planned study procedures.
- Parents provide assent/permission prior to any study procedures.
- Inclusion criteria mothers:
- 1\. The mother's of infants meeting the infant inclusion criteria above.
Exclusion
- Diagnosed immunodeficiency disorder.
- Currently receiving investigational immunomodulatory, probiotic or antiviral agent.
- Infants whose mothers meet the exclusion criteria below.
- Exclusion criteria mothers:
- Diagnosed immunodeficiency disorder
- Currently receiving investigational immunomodulatory, probiotic or antiviral agents
- Lacking the mental capacity (e.g. due to pain, anesthesia, mental impairment) to provide informed consent for themselves or assent for the participation of their infant.
- Having an infant that meets the infant exclusion criteria.
Key Trial Info
Start Date :
July 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT03229967
Start Date
July 5 2017
End Date
December 30 2020
Last Update
May 10 2023
Active Locations (2)
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1
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38105
2
Regional One Health
Memphis, Tennessee, United States, 38105