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NCT04017520 · ClinicalTrials.gov registry record
Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children Over Time
A clinical trial of Atopic Dermatitis Eczema and Wheezing, sponsored by Milton S. Hershey Medical Center.
- Active
- Registry status
- 221
- Enrollment target
- 1
- Study location
NCT04017520 is a study of Atopic Dermatitis Eczema and Wheezing that is active but no longer recruiting, run by Milton S. Hershey Medical Center. The registered enrollment target is 221 participants, above the 174-participant average among 8 other Atopic Dermatitis Eczema trials with a reported enrollment target (27% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04017520, a study of Atopic Dermatitis Eczema and Wheezing, is active but no longer recruiting, sponsored by Milton S. Hershey Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 221 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an observational cohort study of 221 breast-feeding mother-infant dyads delivered at term. The goal of the study is to investigate whether levels of immune-related microRNAs (miRNAs) in maternal breast milk (MBM) influence child atopy risk in the first 12 months, defined as atopic dermatitis, wheezing, or food allergy. Infant exposure to individual miRNA components will be quantified at 0, 4, and 16-weeks after delivery using high throughput RNA sequencing of MBM samples and detailed dietary logs employing the Infant Feeding Practices (IFP) survey. The relationship of individual miRNA exposures (parts per million) and presence/absence of atopy in the 48 weeks after delivery will be assessed, while controlling for environmental exposures (National Survey of Lead hazards and Allergens in Housing), maternal diet, and genetic predisposition. Potential transfer of MBM miRNAs to the infant oropharynx and subsequent impact on immune reactivity will also be explored through RNA sequencing of infant saliva and quantification of cytokine profiles.
Conditions Studied
Study Locations (1)
Pennsylvania
- Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2018-01-18 |
| Est. Completion | 2028-12-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04017520
The ClinicalTrials.gov registry entry for NCT04017520 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 174-participant average among 8 other Atopic Dermatitis Eczema trials with a reported enrollment target (27% higher). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Atopic Dermatitis Eczema appearing as the primary indexed condition, and to 0 interventions.
NCT04017520 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04017520 about?
NCT04017520 is a clinical study titled "Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children Over Time". This is an observational cohort study of 221 breast-feeding mother-infant dyads delivered at term. The goal of the study is to investigate whether levels of immune-related microRNAs (miRNAs) in maternal breast milk (MBM) influence child atopy risk in the first 12 months, defined as atopic dermatitis...
What is the current status of trial NCT04017520?
This trial is currently active not recruiting. The enrollment target is 221 participants. The study started on 2018-01-18. Estimated completion is 2028-12-30.
What conditions does trial NCT04017520 study?
This clinical trial studies the following conditions: Atopic Dermatitis Eczema, Wheezing, Food Allergy in Infants, Atopy.
Who is sponsoring clinical trial NCT04017520?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04017520 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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