Complement: Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Infants who started feeding with the product at ≤ 4 months of age Infants who started feeding with the product at ≤ 4 months of age, either supplemental to breastfeeding or as sole source of feeding |
Other: Dairy and plant based infant formula feeding
Parents have already decided to feed their infant with the product (a dairy and plant based infant formula) daily, starting within the first 4 months of life, continuing for at least 2 months
|
Outcome Measures
Primary Outcome Measures
- Development of weight, length, and head circumference [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 Outcome Measures
- Development of length, BMI, and head circumference [5 Months + 2 weeks]
Agreed clinical experts' judgement about adequate development of length, BMI (derived from weight and length outcomes), and head circumference (adequate/inadequate)
- Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age [5 Months + 2 weeks]
Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age since start of the dairy and plant based infant formula (according to the country specific z-score by age and sex)
- Experience of parent and infant [after using product for 2 and 5 Months]
Parent's and infant's experiences with the dairy and plant based infant formula after using the product for 2 and 5 months and assessed via a digital questionnaire
Eligibility Criteria
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
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Infant started feeding with dairy and plant based infant formula ≤ 4 months of age
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Infant is being fed daily with dairy and plant based infant formula at time of enrolment
Exclusion Criteria:
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Infant started feeding with dairy and plant based infant formula >3 months ago at time of enrolment
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Participation of the infant in any other studies involving infant formula feeding (products) concomitantly
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ncru, Danone Nutricia Research | Utrecht | Netherlands | 3584CT |
Sponsors and Collaborators
- Nutricia Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SBB22R&41357