Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)
Status unconfirmed · Not applicable
Conditions studied: Diet Diversity, Infant Nutrition
In brief
This is a randomized, controlled, open-label, pragmatic, direct-to-participant trial designed for infants. The study will be conducted using a mobile application platform to engage parents with healthy infants and parents with infants with eczema in introducing complementary feeding in line with new feeding guidelines for diet diversity, gather parental experiences of feeding, support early introduction of different food proteins and support feeding of SpoonfulONE.
Key facts
- Study ID
- NCT04803981
- Run by
- Before Brands, Inc
- People needed
- 1500
- Starts
- 2021-04-09
- Expected to finish
- 2023-07-01
- Last updated by the study team
- 2021-04-13
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female 4-6 months of age at time of consent
- Provision of signed and dated informed consent form parent/guardian(s)
- Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod
- In good general health as evidenced by medical history reported by the parent/guardian(s)
- No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients
You may not qualify if…
- Known physician confirmed allergies to any of the ingredients in SO at the time of consent
- Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)
- Participant or parent/guardian unsuitable for the study, at the discretion of the investigator
- Sibling in the home is already enrolled in the study
Where it is running
- Duke Clinical Research Institute — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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