Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

— MiBPD  

Official title:

Gastrointestinal Microbiota Influence on the Pathogenesis of Bronchopulmonary Dysplasia in Very Low Birthweight Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229967
• Other study ID #: 17-05311-XP
• Status: Completed
• Start date: July 5, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2023
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Gender: All
• Age group: 0 Days to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

Intervention

Diagnostic Test:
• 16S rRNA stool microbiome sequencing.
This is an observational cohort that will undergo gut microbiome sequencing.

Locations

Country	Name	City	State
United States	LeBonheur Children's Hospital	Memphis	Tennessee
United States	Regional One Health	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (1)

Willis KA, Purvis JH, Myers ED, Aziz MM, Karabayir I, Gomes CK, Peters BM, Akbilgic O, Talati AJ, Pierre JF. Fungi form interkingdom microbial communities in the primordial human gut that develop with gestational age. FASEB J. 2019 Nov;33(11):12825-12837. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal perinatal antibiotic exposure		from hospital admission until birth of infant
Other	Infant antibiotic exposure		birth until 36 weeks corrected gestational age
Primary	Bronchopulmonary dysplasia (BPD)	National Institute of Child Health and Disease (NICHD) consensus definition	36 weeks corrected gestational age, until the date of death or initial hospital discharge whichever occurs first, assessed up to up to 3 months
Primary	Death		from the date of enrollment until the date of death or initial hospital discharge, whichever occurs first, assessed up to up to 3 months
Secondary	Necrotizing Enterocolitis (NEC)	Modified Bell's staging for NEC > Stage 2	from the date of enrollment until the date of initial hospital discharge or death, whichever occurs first, assessed up to up to 3 months
Secondary	Maternal Chorioamnionitis		presence on admission