Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-6
SponsorSociété des Produits Nestlé (SPN)
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
1. 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.
Trial design
Design model
Crossover
Treatments tested in this trial
A
Other interventionControl: base infant rice-based cereal with no added sugar
B
Other interventionTest 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.
C
Other interventionTest 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.
D
Other interventionTest 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.
E
Other interventionTest 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.
Treatment groups
153 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: A, B, E, C, DOther 5 interventions
Group B: B, C, A, D, EOther 5 interventions
Group C: C, D, B, E, AOther 5 interventions
Group D: D, E, C, A, BOther 5 interventions
Group E: E, A, D, B, COther 5 interventions
Group F: D, C, E, B, AOther 5 interventions
Group G: E, D, A, C, BOther 5 interventions
Group H: A, E, B, D, COther 5 interventions
Group I: B, A, C, E, DOther 5 interventions
Group J: C, B, D, A, EOther 5 interventions
Trial outcomes
Primary outcomes
1
Effects of different inclusions in infant cereals on the number of chews according to the age group.
Define the change in number of chews observed during consumption of infant cereals with or without different inclusions based on manual video coding
Time frame
Immediately after the product intakeSecondary outcomes
1
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.
Comparer chewing duration extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group.
Time frame
Immediately after the product intake2
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.
Comparer chewing rate extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group.
Time frame
Immediately after the product intake3
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.
Comparer the observation of tongue lateral movements extracted from video manual coding and the BabyFaceReader automatically calculated metrics between products with different textures for each age group, using a 3 points categorical scale.
Time frame
Immediately after the product intake4
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.
Comparer the observation of rotary chewing motions extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group, using a 3 points categorical scale.
Time frame
Immediately after the product intakeSponsors and contacts
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Source ClinicalTrials.gov