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

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Nutricia

Status

Terminated

Conditions

Infant Growth
Parent and Infant User Experience

Treatments

Other: Dairy and plant based infant formula feeding

Study type

Observational

Funder types

Industry

Identifiers

NCT05804214
SBB22R&41357

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

Under 7 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. 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.
  2. Parents' intention to feed their infant with dairy and plant based infant formula for at least 2 months as of start with product
  3. Infant started feeding with dairy and plant based infant formula ≤ 4 months of age
  4. Infant is being fed daily with dairy and plant based infant formula at time of enrolment

Exclusion criteria

  1. Infant started feeding with dairy and plant based infant formula >3 months ago at time of enrolment
  2. Participation of the infant in any other studies involving infant formula feeding (products) concomitantly

Trial design

2 participants in 1 patient group

Infants who started feeding with the product at ≤ 4 months of age
Description:
Infants who started feeding with the product at ≤ 4 months of age, either supplemental to breastfeeding or as sole source of feeding
Treatment:
Other: Dairy and plant based infant formula feeding

Trial contacts and locations

1

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Central trial contact

Danone Nutricia Research

Data sourced from clinicaltrials.gov

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