Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Bronchitis, Hematology |
| Therapuetic Areas: | Hematology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2018 |
| Start Date: | July 5, 2017 |
| End Date: | June 30, 2019 |
Gastrointestinal Microbiota Influence on the Pathogenesis of Bronchopulmonary Dysplasia in Very Low Birthweight Neonates
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, the investigators will determine the complexity of the gut microbiota, the
genera of the bacteria that naturally live in the gut, and determine if the relative
diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the
investigators propose to characterize the microbiota of human premature newborns with BPD,
then validate this potential mechanism in mice. The investigators will enroll very low
birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le
Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A
cohort of well full term newborns will also be enrolled. Non-invasive stool samples will be
obtained weekly over the first month of life. Infants that eventually develop BPD will be
paired with infants that did not develop BPD. Stool samples from these infants will be sent
for analysis. The investigators expect that reduced complexity of the gut microbiome is
associated with BPD. The investigators will model the contribution of reduced microbiome
complexity to the risk to develop BPD or death, as well as the association with disease
severity. The project investigates important factors leading to the development of BPD, and
has the potential to directly translate to therapy for the most significant pulmonary
complication of prematurity.
development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants.
Specifically, the investigators will determine the complexity of the gut microbiota, the
genera of the bacteria that naturally live in the gut, and determine if the relative
diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the
investigators propose to characterize the microbiota of human premature newborns with BPD,
then validate this potential mechanism in mice. The investigators will enroll very low
birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le
Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A
cohort of well full term newborns will also be enrolled. Non-invasive stool samples will be
obtained weekly over the first month of life. Infants that eventually develop BPD will be
paired with infants that did not develop BPD. Stool samples from these infants will be sent
for analysis. The investigators expect that reduced complexity of the gut microbiome is
associated with BPD. The investigators will model the contribution of reduced microbiome
complexity to the risk to develop BPD or death, as well as the association with disease
severity. The project investigates important factors leading to the development of BPD, and
has the potential to directly translate to therapy for the most significant pulmonary
complication of prematurity.
Inclusion Criteria:
1. 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.
2. Parents can understand and comply with planned study procedures.
3. 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 Criteria:
1. Diagnosed immunodeficiency disorder.
2. Currently receiving investigational immunomodulatory, probiotic or antiviral agent.
3. Infants whose mothers meet the exclusion criteria below.
Exclusion criteria mothers:
1. Diagnosed immunodeficiency disorder
2. Currently receiving investigational immunomodulatory, probiotic or antiviral agents
3. 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.
4. Having an infant that meets the infant exclusion criteria.
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