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Infant NutritionNCT02626143

Effect of Feeding Mode on Infant Growth and Cognitive Function

A study testing Investigational nutrient-rich whey protein formula and Cow's milk based formula in people with Infant Nutrition, run by Mead Johnson Nutrition at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk. Read more about this study

Who is it for?
Ages 0 to 120 daysHealthy volunteers can take part
Conditions the study is for
Infant Nutrition
What is being tested?
Investigational nutrient-rich whey protein formula and Cow's milk based formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
582 participants
Where
1 siteChile
Study dates
Feb 2016to Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 120 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Singleton, 0-120 days of age at study entry
  • Term infant with birth weight of 2500 to 4500 grams
  • Exclusively feed infant formula or exclusively feeding breast milk
  • Signed informed consent

Who cannot join

  • History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised.
  • Feeding difficulties or formula intolerance
  • Receiving complementary feedings

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Instituto de Nutricion y Tecnologia de los Alimentos

    Santiago

Other trials in Chile

About this study

This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.

Being tested
Investigational nutrient-rich whey protein formula, Cow's milk based formula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigational nutrient-rich whey protein formulaOther

  • Cow's milk based formulaOther

Study groups in NCT02626143
Study groupRoleWhat they receive
Investigational nutrient-rich whey protein formulaExperimentalNot described
Receives: Other: Investigational nutrient-rich whey protein formula
Cow's milk based formulaActive comparatorNot described
Receives: Other: Cow's milk based formula
Breast milkNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    Measured: 24 months

  2. Auditory Event-related Potential

    Measured: 24 months

  3. Body length

    Measured: 24 months

  4. Head circumference

    Measured: 24 months

Secondary outcomes (12)

  1. Dietary Intake

    Measured: 24 months

  2. Medically confirmed adverse events

    Measured: 24 months

  3. Body Composition: Air Displacement Plethysmography

    Measured: 6 months

  4. Body Composition: Deuterium Dilution

    Measured: 12 and 24 months

  5. Blood sample: Micronutrient status

    Measured: 24 months

  6. Blood sample: Metabolic markers

    Measured: 24 months

  7. Bayley Scales of Infant and Toddler Development

    Measured: 12 months

  8. Sleep measures (Amount of time awake & asleep in a 7-day period)

    Measured: 24 months

  9. Language development: Native3 Phoneme Repertory

    Measured: 12 months

  10. Language development: Word Discovery

    Measured: 10 months

  11. Language development: Rule Inference

    Measured: 10 months

  12. Language development: MacArthur Communicative Development Inventory

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionFeb 2019
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
582 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02626143
Sponsor's protocol ID
6029
Status last verified
Nov 2020
First submitted
3 Dec 2015
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Toro-Campos R, Algarin C, Peirano P, Pena M, Murguia-Peniche T, Wu SS, Uauy R. Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition randomized controlled Trial (ChiNuT). BMC Pediatr. 2020 May 18;20(1):225. doi: 10.1186/s12887-020-02087-9.

    PubMed 32423392

Questions about this trial

What is this clinical trial studying?

A study testing Investigational nutrient-rich whey protein formula and Cow's milk based formula in people with Infant Nutrition, run by Mead Johnson Nutrition at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02626143, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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