Chewing Capability Study for Infants and Toddlers

Nestlé

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Industry

Identifiers

NCT02156986

13.03.INF

Details and patient eligibility

About

The main objective of the study is to conduct a pilot study on the characterization of the mastication abilities of infants and toddlers using different commercial cereal based products in order to gain knowledge and be able to plan future studies.

Enrollment: 68 patients

Sex: All

Ages: 9 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Born at term (37+ weeks)
• Familiar with solid foods
• No known history of food allergies
• Child must be within 2 weeks of the targeted age group for 9 months, within 1 month for 12 months, within 2 months for 18 and 24 months, and within 3 months for 36 months for this study.
• English must be the primary language of the participant and family.
• Having obtained his/her caregiver's or legal representative's informed consent.

Exclusion criteria

• History of speech/language, cognitive, or physical impairments as indicated on the self-reported medical history questionnaire completed by caregiver or legal guardian
• Any previously undiagnosed speech/language or cognitive impairment detected by the Investigator. In the case a subject is identified as being at risk for a communication or feeding impairment, the caregiver will be notified and provided with a list of local speech-language pathology providers who could perform a formal assessment
• History of poor weight gain/ weight loss, food allergies, difficulties with sucking, difficulties with chewing and/ or swallowing, frequent drooling (for age groups 18, 24, and 36 months), frequent choking, gastro-esophageal reflux, frequent spitting up/ vomiting (for age groups 18, 24, and 36 months) or irritability after feedings/ eating
• Latex allergies
• Currently participating in or having participated in a similar clinical trial related to food/diet within the last 9 months
• Caregiver must not be under the age of 18 years old.

Trial design

68 participants in 5 patient groups

9 month old infant

12 month old infant

18 month old toddler

24 month old toddler

36 month old toddler