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NCT04957992 · ClinicalTrials.gov registry record · NA

BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)

A NA study, sponsored by Abbott Nutrition.

Completed
Registry status
NA
Development phase
607
Enrollment target

NCT04957992: Completed NA study, sponsored by Abbott Nutrition.

NCT04957992 is a NA study that has completed, run by Abbott Nutrition. The registered enrollment target is 607 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04957992, a NA study, has completed, sponsored by Abbott Nutrition.

COMPLETED
Registry status
NA
Development phase
607 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.

Primary Outcome

weight for age z-score

Interventions

  • OTHER Experimental Infant Formula
  • OTHER Control Infant Formula
  • OTHER Control Toddler Drink
  • OTHER Experimental Toddler Drink
  • OTHER Human Milk

Trial Details

FieldValue
Enrollment Target 607 participants
Start Date 2021-07-21
Est. Completion 2025-05-12
Phase NA
Abbott Nutrition

89 total trials

What the finished NCT04957992 record still lists

NCT04957992 is an interventional study that assigns participants to a tested intervention. The registered 607 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 5 interventions - of which Experimental Infant Formula is the first listed.

NCT04957992 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04957992 about?

NCT04957992 is a clinical study titled "BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)". The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.

What is the current status of trial NCT04957992?

This trial is currently completed. It is a NA study. The enrollment target is 607 participants. The study started on 2021-07-21. Estimated completion is 2025-05-12.

What interventions are being tested in trial NCT04957992?

The interventions under investigation include: Experimental Infant Formula (OTHER), Control Infant Formula (OTHER), Control Toddler Drink (OTHER), Experimental Toddler Drink (OTHER), Human Milk (OTHER).

Who is sponsoring clinical trial NCT04957992?

This trial is sponsored by Abbott Nutrition, which has 89 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04957992's enrollment target sits among peer trials

607 162nd of 2000 higher than 1,839 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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Source: ClinicalTrials.gov NCT04957992, the US trial registry maintained by the National Library of Medicine. NCT04957992 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.