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NCT03884309 · ClinicalTrials.gov registry record · NA
Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula
A NA study of Protein Intolerance, sponsored by Abbott Nutrition.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 6
- Study locations
NCT03884309: Completed NA study of Protein Intolerance, sponsored by Abbott Nutrition.
NCT03884309 is a NA study of Protein Intolerance that has completed, run by Abbott Nutrition. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03884309, a NA study of Protein Intolerance, has completed, sponsored by Abbott Nutrition.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.
Primary Outcome
Change in weight for age z-score
Conditions Studied
Interventions
- OTHER Experimental Hydrolyzed Protein Infant Formula
Study Locations (6)
Texas
- Ventavia Research Group, LLC - Houston
- DCOL Center for Clinical Research - Longview
Georgia
- Paramount Research Solutions - College Park
Kentucky
- Michael W. Simon, M.D., PSC - Nicholasville
Nebraska
- Midwest Children's Health Research Institute - Lincoln
Tennessee
- Memphis & Shelby County Pediatric Group - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2020-01-07 |
| Phase | NA |
What the finished NCT03884309 record still lists
NCT03884309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Protein Intolerance appearing as the primary indexed condition, and to 1 intervention - of which Experimental Hydrolyzed Protein Infant Formula is the first listed.
NCT03884309 lists 6 locations in 5 states (Texas, Georgia, Kentucky).
Frequently Asked Questions
What is clinical trial NCT03884309 about?
NCT03884309 is a clinical study titled "Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula". This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.
What is the current status of trial NCT03884309?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2019-03-25. Estimated completion is 2020-01-07.
What conditions does trial NCT03884309 study?
This clinical trial studies the following conditions: Protein Intolerance.
What interventions are being tested in trial NCT03884309?
The interventions under investigation include: Experimental Hydrolyzed Protein Infant Formula (OTHER).
Who is sponsoring clinical trial NCT03884309?
This trial is sponsored by Abbott Nutrition, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03884309 being conducted?
This trial has 6 study locations across Georgia, Kentucky, Nebraska, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03884309's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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