RecruitingNot Applicable

Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children

Spain153 participantsStarted 2025-11-05

Plain-language summary

The purpose of this study is to define the effects of different inclusions in infant cereals on the adaptation of oral motor behavior and skills displayed at a given age.

Who can participate

Age range

6 Months – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Children between 6 months (182 days) to 24 months (730 days) of age (from enrollment to last visit):
.1. \[182-242\]-days of age from V1 to last visit for the 6-8-month-old age group 1.2. \[243-364\]-days of age from V1 to last visit for the 8-12-month-old age group 1.3. \[365-547\]-days of age from V1 to last visit for the 12-18-month-old age group 1.4. \[548-730\]-days of age from V1 to last visit for the 18-24-month-old age group
. Singleton, full-term infants (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
. Healthy children based on medical history as reported by parent(s) / LAR(s).
. Sit upright with or without support (such as, sitting with back against a chair or while being held) as reported by parent(s) / LAR(s)
. Keep head steady when in a supported position
. Have already started complementary feeding as recommended by their health care professional (have started solid food beyond breastmilk or infant formula)
. Written informed consent is obtained from at least one parent(s) / LAR(s).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effects of different inclusions in infant cereals on the number of chews according to the age group.

Timeframe: Immediately after the product intake

Trial details

NCT IDNCT07318506

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

Julia Mauger

+41792019835 JULIA.MAUGER@RDLS.NESTLE.COM

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