Actively Recruiting
Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children
Led by Société des Produits Nestlé (SPN) · Updated on 2026-01-06
153
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 6 months (182 days) and 24 months (730 days) at enrollment and last visit
- Full-term singletons (born at 37 or more completed weeks of gestation) with birth weight between 2.5 kg and 4.5 kg
- Healthy children based on medical history reported by parent(s) or legally authorized representative(s)
- Able to sit upright with or without support and keep head steady when supported
- Have started complementary feeding as recommended by healthcare professional
- Written informed consent obtained from at least one parent or legally authorized representative
- Parent(s) or legally authorized representative(s) able to provide proof of parental authority and identity
- Parent(s) or legally authorized representative(s) understand study documents and consent
- Parent(s) or legally authorized representative(s) willing and able to follow study requirements within the time frame
You will not qualify if you...
- Infant's parents or legally authorized representatives are under 18 years old
- History of oral or facial malformations or surgery such as cleft lip, cleft palate, or tongue-tie
- History of tube feeding for any reason
- Presence of chronic illness, congenital malformations, surgical sequela, gastroesophageal reflux disease, behavioral disorders, neurodevelopmental delay, or illnesses affecting feeding
- Feeding or swallowing difficulties, history of choking, or high choking risk
- Known or suspected food allergies or intolerances in child or siblings, including milk protein allergy, celiac disease, lactose intolerance, soy allergy, fish allergy, or others
- Undernutrition as defined by age-group weight thresholds: less than 6 kg for 6-8 months, less than 6.5 kg for 8-12 months, less than 7.5 kg for 12-18 months, less than 8.5 kg for 18-24 months
- Participation in another clinical intervention study affecting outcomes within 4 weeks prior to enrollment or participation in another age group of this study
- Family or hierarchical relationships with members of the research team
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Instituto DYM S.A.
Barcelona, Spain, 08037
Actively Recruiting
2
Institute of Agrochemistry & Food Technology CSIC
Valencia, Spain, 46980
Actively Recruiting
Research Team
J
Julia Mauger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
10
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