Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant Growth
- Sponsor
- Nutricia Research
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Development of weight, length, and head circumference
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
A study to assess and evaluate adequate growth in infants receiving a dairy and plant based infant formula in a real-world setting, and parents' and infants' experiences with this infant formula.
Detailed Description
The study collects growth data from 58 participating infants whose parents autonomously decided to use the dairy and plant based infant formula for their infant daily within the first three months of their infant's life, either supplemental to breastfeeding or as sole source of feeding. Parents are asked to complete 2-3 online questionnaires in which data is collected on infant growth (as assessed during regular visits to the Municipal Child Healthcare Clinic), feeding characteristics, parent and infant experience with the product, and whether their infant has been to a doctor or is taking medication.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Parents autonomously decided to feed their infant with at least one bottle per day of dairy and plant based infant formula in combination with breastfeeding or as sole source of feeding.
- •Parents' intention to feed their infant with dairy and plant based infant formula for at least 2 months as of start with product
- •Infant started feeding with dairy and plant based infant formula ≤ 4 months of age
- •Infant is being fed daily with dairy and plant based infant formula at time of enrolment
Exclusion Criteria
- •Infant started feeding with dairy and plant based infant formula \>3 months ago at time of enrolment
- •Participation of the infant in any other studies involving infant formula feeding (products) concomitantly
Outcomes
Primary Outcomes
Development of weight, length, and head circumference
Time Frame: 5 Months +2 weeks
Agreed clinical experts' judgement about development of weight, length and head circumference (adequate/inadequate) as measured at the Municipal Child Healthcare Clinic visits and transcribed by the parents in a digital tool
Secondary Outcomes
- Development of length, BMI, and head circumference(5 Months + 2 weeks)
- Experience of parent and infant(after using product for 2 and 5 Months)
- Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age(5 Months + 2 weeks)