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

Terminated

• Conditions: Parent and Infant User Experience; Infant Growth
• Interventions: Other: Dairy and plant based infant formula feeding

• Registration Number: NCT05804214
• Lead Sponsor: Nutricia Research

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.

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 Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-07
• Study Start: 2023-04-11
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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
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)

Trial Locations

Locations (1)

Ncru, Danone Nutricia Research; 🇳🇱 Utrecht, Netherlands