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

NCT ID: NCT05804214

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-11

Study Completion Date

2023-07-14

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.

Conditions

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Infant Growth Parent and Infant User Experience

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Dairy and plant based infant formula feeding

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutricia Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ncru, Danone Nutricia Research

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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SBB22R&41357

Identifier Type: -

Identifier Source: org_study_id

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