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Study early terminated
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dairy and plant based infant formula feeding | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Development of weight, length, and head circumference | 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 | 5 Months +2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Development of length, BMI, and head circumference | Agreed clinical experts' judgement about adequate development of length, BMI (derived from weight and length outcomes), and head circumference (adequate/inadequate) | 5 Months + 2 weeks |
| Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age |
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Inclusion Criteria:
Exclusion Criteria:
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Infants that are fed with dairy and plant based infant formula ≤ 4 months of age. Infants should be enrolled within three months after start with dairy and plant based infant formula.
Before screening, parents should already autonomously have decided to use dairy and plant based infant formula for their infant according to the label of the product.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ncru, Danone Nutricia Research | Utrecht | 3584CT | Netherlands |
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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) |
| 5 Months + 2 weeks |
| Experience of parent and infant | 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 | after using product for 2 and 5 Months |