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Completed

NCT Number: NCT03229967

Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

0 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

LeBonheur Children's Hospital, Memphis, Tennessee, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • The mother's of infants meeting the infant inclusion criteria above.

Exclusion criteria

  • 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.

Treatment and study plan

16S rRNA stool microbiome sequencing.

Diagnostic Test

This is an observational cohort that will undergo gut microbiome sequencing.

Primary outcomes

  1. Bronchopulmonary dysplasia (BPD)

    Time frame: 36 weeks corrected gestational age, until the date of death or initial hospital discharge whichever occurs first, assessed up to up to 3 months

    National Institute of Child Health and Disease (NICHD) consensus definition

  2. Death

    Time frame: 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 outcomes

  1. Necrotizing Enterocolitis (NEC)

    Time frame: from the date of enrollment until the date of initial hospital discharge or death, whichever occurs first, assessed up to up to 3 months

    Modified Bell's staging for NEC > Stage 2

  2. Maternal Chorioamnionitis

    Time frame: presence on admission

Other outcomes

  1. Maternal perinatal antibiotic exposure

    Time frame: from hospital admission until birth of infant

  2. Infant antibiotic exposure

    Time frame: birth until 36 weeks corrected gestational age

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

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

Acronym: MiBPD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2017
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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