Bronchopulmonary DysplasiaMiBPDNCT03229967
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia, run by University of Tennessee at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 7 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- 16S rRNA stool microbiome sequencing.
- How many people
- 197 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jul 2017to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 7 days
- All sexes
- Child
Study population: Study Population will be composed of VLBW infants (birthweight less than 1500 grams) and their mothers (Including 40 term infants and their mothers)
Who may be able to join
- 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.
- 1. The mother's of infants meeting the infant inclusion criteria above.
Who cannot join
- Diagnosed immunodeficiency disorder.
- Currently receiving investigational immunomodulatory, probiotic or antiviral agent.
- Infants whose mothers meet the exclusion criteria below.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
LeBonheur Children's Hospital
Memphis, Tennessee, 38105
Regional One Health
Memphis, Tennessee, 38105
About this study
Official title: 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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- 16S rRNA stool microbiome sequencing.
- Keywords
- Bronchopulmonary dysplasia, Microbiome, Microbiota, Premature infant, Observational cohort study
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16S rRNA stool microbiome sequencing.Diagnostic test
This is an observational cohort that will undergo gut microbiome sequencing.
| Study group | Role | What they receive |
|---|---|---|
| Exploration Cohort | Up to 150 VLBW (very low birthweight) infants enrolled from the Regional One Health NICU (neonatal intensive care unit). Weekly stool samples will be obtained. After 36 weeks infants diagnosed with BPD per NIH guidelines, will be matched with infants without BPD. Stool samples from these infants will be sent for 16s rRNA (ribosomal ribonucleic acid) sequencing after conclusion of initial enrollment period. ITS (internal transcribed spacer) DNA may also be used to characterize fungal communities. Receives: Diagnostic Test: 16S rRNA stool microbiome sequencing. | |
| Validation Cohort | Up to 10 VLBW infants enrolled from the Le Bonheur Children's Hospital NICU. Weekly stool samples will be obtained. After 36 weeks infants diagnosed with BPD per NIH guidelines willl be matched with infants without BPD. Stool samples from these infants will be sent for 16s rRNA sequencing after conclusion of initial enrollment period. Receives: Diagnostic Test: 16S rRNA stool microbiome sequencing. | |
| Well Baby Cohort | 40 Well Baby Infants have been enrolled and may be used for secondary analysis of microbial community composition of the meconium. Receives: Diagnostic Test: 16S rRNA stool microbiome sequencing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary dysplasia (BPD)
National Institute of Child Health and Disease (NICHD) consensus definition
Measured: 36 weeks corrected gestational age, until the date of death or initial hospital discharge whichever occurs first, assessed up to up to 3 months
Death
Measured: 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 (2)
Necrotizing Enterocolitis (NEC)
Modified Bell's staging for NEC > Stage 2
Measured: from the date of enrollment until the date of initial hospital discharge or death, whichever occurs first, assessed up to up to 3 months
Maternal Chorioamnionitis
Measured: presence on admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start5 Jul 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kent Avery Willis, MD, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229967
- Sponsor's protocol ID
- 17-05311-XP
- Acronym
- MiBPD
- Status last verified
- May 2023
- First submitted
- 11 Jul 2017
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: MiSeq data will be placed in a public repository
Publications
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. doi: 10.1096/fj.201901436RR. Epub 2019 Aug 31.
PubMed 31480903
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Microbiota Influence on the Pathogenesis of Bronchopulmonary Dysplasia in Very Low Birthweight Neonates
- ClinicalTrials.gov ID
- NCT03229967
- Acronym / sponsor ID
- MiBPD / 17-05311-XP
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary dysplasia, Microbiome, Microbiota, Premature infant, Observational cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exploration Cohort | – | Diagnostic Test: 16S rRNA stool microbiome sequencing.Up to 150 VLBW (very low birthweight) infants enrolled from the Regional One Health NICU (neonatal intensive care unit). Weekly stool samples will be obtained. After 36 weeks infants diagnosed with BPD per NIH guidelines, will be matched with infants without BPD. Stool samples from these infants will be sent for 16s rRNA (ribosomal ribonucleic acid) sequencing after conclusion of initial enrollment period. ITS (internal transcribed spacer) DNA may also be used to characterize fungal communities. |
| Validation Cohort | – | Diagnostic Test: 16S rRNA stool microbiome sequencing.Up to 10 VLBW infants enrolled from the Le Bonheur Children's Hospital NICU. Weekly stool samples will be obtained. After 36 weeks infants diagnosed with BPD per NIH guidelines willl be matched with infants without BPD. Stool samples from these infants will be sent for 16s rRNA sequencing after conclusion of initial enrollment period. |
| Well Baby Cohort | – | Diagnostic Test: 16S rRNA stool microbiome sequencing.40 Well Baby Infants have been enrolled and may be used for secondary analysis of microbial community composition of the meconium. |
Who may qualify
- Ages
- 0 to 7 days
- Sex
- All
- Age groups
- Child
- Study population
- Study Population will be composed of VLBW infants (birthweight less than 1500 grams) and their mothers (Including 40 term infants and their mothers)
Key inclusion criteria (4 listed)
- 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.
- 1. The mother's of infants meeting the infant inclusion criteria above.
Key exclusion criteria (7 listed)
- Diagnosed immunodeficiency disorder.
- Currently receiving investigational immunomodulatory, probiotic or antiviral agent.
- Infants whose mothers meet the exclusion criteria below.
- Diagnosed immunodeficiency disorder
- Currently receiving investigational immunomodulatory, probiotic or antiviral agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16S rRNA stool microbiome sequencing.This is an observational cohort that will undergo gut microbiome sequencing. | Diagnostic test | Exploration Cohort, Validation Cohort, Well Baby Cohort |
Primary outcome
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
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
2 secondary outcomes
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
Maternal Chorioamnionitis
Time frame: presence on admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Results publication: PubMed 31480903Willis 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. doi: 10.1096/fj.201901436RR. Epub 2019 Aug 31.
- Individual participant dataSharing planned: No. MiSeq data will be placed in a public repository
Related trials for Bronchopulmonary Dysplasia
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by University of Tennessee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.