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NCT04835935 · ClinicalTrials.gov registry record
Microbiome, Atopic Disease, Prematurity
A clinical trial of Prematurity and Atopy, sponsored by Sydney Leibel.
- Active
- Registry status
- 51
- Enrollment target
- 2
- Study locations
NCT04835935 is a study of Prematurity and Atopy that is active but no longer recruiting, run by Sydney Leibel. The registered enrollment target is 51 participants, below the 209-participant average among 21 other Prematurity trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04835935, a study of Prematurity and Atopy, is active but no longer recruiting, sponsored by Sydney Leibel.
- ACTIVE NOT RECRUITING
- Registry status
- 51 participants
- Enrollment target
- 2
- Study locations
Study Summary
There is increasing recognition that the microbiome may be important in the development of allergic disease. Asthma is the most prevalent pediatric chronic disease and affects more than 300 million people worldwide. For unclear reasons, those infants born at 34 weeks and earlier are three times as likely to develop asthma. Factors such as formula feeding, C-section delivery and antibiotic exposure may play a role. Recent evidence has identified a "critical window" in early life where gut and breast milk microbial changes are most influential. The investigators propose a novel study to follow a cohort of premature babies in the NICU and after discharge home. The investigators aim to examine whether various exposures of babies in the NICU impact their milk and gut microbiome and lead to asthma and allergies. Our specific aims are: 1. To assess if there is a specific pattern of gut and/or breast milk microbiome over time that is affected by the type of nutrition a baby receives (donor vs maternal vs formula) or other exposures such as antibiotics. 2. Assess whether there are patterns in the microbiome associated with the development of allergic sensitization patterns. 3. Determine if early patterns of the microbiome and allergic sensitization predict allergic conditions (food allergies, allergic rhinitis, eczema, asthma) by 2 years of age. The investigators will recruit approximately 50 subjects born at 34 weeks of gestation or earlier from two local level III NICU. These subjects will be followed over their NICU course with weekly stool, milk feed, and oral saliva collection as well as documentation of relevant events including prenatal history, delivery history, nutrition and breast feeding history and antibiotic courses. Further samples will be collected after discharge at research visits that will take place Rady Children's Hospital until 4-6 years of age. At these visits, standardized allergy questionnaires and a blood allergy panel will be obtained. Together t
Conditions Studied
Interventions
- OTHER microbiome pattern
Study Locations (2)
California
- Scripps Memorial Hospital - Rady NICU - San Diego
- University of California, San Diego - Jacobs NICU - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2030-12-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04835935
The ClinicalTrials.gov registry entry for NCT04835935 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 21 other Prematurity trials with a reported enrollment target (76% lower). The listed sponsor is Sydney Leibel, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Prematurity appearing as the primary indexed condition, and to 1 intervention - of which microbiome pattern is the first listed.
NCT04835935 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04835935 about?
NCT04835935 is a clinical study titled "Microbiome, Atopic Disease, Prematurity". There is increasing recognition that the microbiome may be important in the development of allergic disease. Asthma is the most prevalent pediatric chronic disease and affects more than 300 million people worldwide. For unclear reasons, those infants born at 34 weeks and earlier are three times as l...
What is the current status of trial NCT04835935?
This trial is currently active not recruiting. The enrollment target is 51 participants. The study started on 2019-06-01. Estimated completion is 2030-12-30.
What conditions does trial NCT04835935 study?
This clinical trial studies the following conditions: Prematurity, Atopy.
What interventions are being tested in trial NCT04835935?
The interventions under investigation include: microbiome pattern (OTHER).
Who is sponsoring clinical trial NCT04835935?
This trial is sponsored by Sydney Leibel, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04835935 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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