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NCT05986539 · ClinicalTrials.gov registry record
Early Life Feeding Exposure and Infant Immune and Health Status.
A clinical trial of Infant Development and Maternal Behavior, sponsored by University of Idaho.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT05986539 is a study of Infant Development and Maternal Behavior that is actively recruiting participants, run by University of Idaho. The registered enrollment target is 60 participants, below the 401-participant average among 30 other Infant Development trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05986539, a study of Infant Development and Maternal Behavior, is actively recruiting participants, sponsored by University of Idaho.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants. Objective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions. Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers. Outcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.
Conditions Studied
Interventions
- OTHER Observational
Study Locations (1)
Idaho
- University of Idaho - Moscow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-01-12 |
| Est. Completion | 2025-04-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05986539
The ClinicalTrials.gov registry entry for NCT05986539 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 401-participant average among 30 other Infant Development trials with a reported enrollment target (85% lower). The listed sponsor is University of Idaho, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Infant Development appearing as the primary indexed condition, and to 1 intervention - of which Observational is the first listed.
NCT05986539 reports 1 study location spanning 1 distinct geographic area - top geographies include Idaho.
Frequently Asked Questions
What is clinical trial NCT05986539 about?
NCT05986539 is a clinical study titled "Early Life Feeding Exposure and Infant Immune and Health Status.". Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on t...
What is the current status of trial NCT05986539?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2024-01-12. Estimated completion is 2025-04-30.
What conditions does trial NCT05986539 study?
This clinical trial studies the following conditions: Infant Development, Maternal Behavior, Breast Milk Collection, Maternal Obesity.
What interventions are being tested in trial NCT05986539?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT05986539?
This trial is sponsored by University of Idaho, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05986539 being conducted?
This trial has 1 study location across Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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