Observational Study of Infants Fed With Dairy and Plant Based Infant Formula

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Study of Infants Fed With Dairy and Plant Based Infant Formula

Conditions
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Infant Growth, Parent and Infant User Experience

Intervention / Treatment
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* Other: Dairy and plant based infant formula feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants who started feeding with the product at ≤ 4 months of age<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complement, infant formula, dairy and plant based