RecruitingNot ApplicableNCT07318506

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

Sponsor

Société des Produits Nestlé (SPN)

Enrollment

153 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Infant and Young Child Feeding

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.

Eligibility

Min Age: 6 MonthsMax Age: 6 Months

Inclusion Criteria11

Children between 6 months (182 days) to 24 months (730 days) of age (from enrollment to last visit):
\[182-242\]-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).
Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity.
Parent(s) / LAR(s) must understand the informed consent and other study documents.
Parent(s) / LAR(s) are willing and able to fulfill the requirements of the study protocol within the study timeframe.

Exclusion Criteria7

\. Infant's parents or LARs have not reached legal age of majority (18 years) 2. Children with history of oral/facial malformations or surgery (i.e. cleft lip, cleft palate, tongue-tie/ankyloglossia), or history of tube feeding for any reason.
\. Children with any chronic illness, congenital malformations (e.g., esophageal or intestinal atresia), surgical sequela (e.g., short bowel syndrome), gastroesophageal reflux disease, behavioral disorders, neurodevelopmental delay or illness that impacts feeding. \[children with an acute illness, such as a cold, gastroenteritis etc. can be included but can only attend the visits once they have recovered\].
\. Children with feeding or swallowing difficulties/disorders, history of choking, or at high risk of choking.
\. Child or sibling(s) who has known or suspected food allergy or intolerance, such as cows' milk protein allergy, celiac disease, lactose intolerance, soy allergy, fish allergy, or any other suspected or confirmed food allergies or intolerance.
\. Children with undernutrition as determined by age-group weight threshold (based on parental reports): weight at \[6-8\[month \< 6 kg; weight at \[8-12\[months: \< 6.5 kg; weight at \[12-18\[months: \< 7.5 kg; weight at \[18-24\] months: \< 8.5 kg.
\. Child is currently participating in or has participated in another intervention clinical study that impacts study outcomes within 4 weeks prior to enrolment or has participated in another age group of this study.
\. Family or hierarchical relationships with the research team members.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERA

Control: base infant rice-based cereal with no added sugar

OTHERB

Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 1 for 6-8 months age group; type 4 for 8-12 months age group; type 4 for 12-18 months age group; type 9 for 18-24 months age group.

OTHERC

Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 2 for 6-8 months age group; type 5 for 8-12 months age group; type 6 for 12-18 months age group; type 10 for 18-24 months age group.

OTHERD

Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 3 for 6-8 months age group; type 6 for 8-12 months age group; type 8 for 12-18 months age group; type 11 for 18-24 months age group.

OTHERE

Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 7 for 8-12 months and 18-24 months age groups. Not applicable for 6-8 months and 18-24 months age group.