Chewing Capability Study for Infants and Toddlers

NCT02156986 | Completed

• 1 other identifier: 13.03.INF
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Muscle activities involved in the mastication using Electromyography (EMG)

  One day during the study visit 2

Study Arms (5)

9 month old infant

12 month old infant

18 month old toddler

24 month old toddler

36 month old toddler

Eligibility Criteria

• Age: 9 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The subjects investigated will be healthy infants and toddlers ranging from 9 to 36 months in 5 groups: * 9 months (±2 weeks), * 12 months (±1 month), * 18 months (±2 months), * 24 months (±2 months), * 36 months (±3 months).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

MGH Institute of Health Professions

Boston, Massachusetts, 02129-4557, United States

Location

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 5, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

US (1)