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

NCT05804214 | Terminated

• 1 other identifier: SBB22R&41357
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Growth; Parent and Infant User Experience

Keywords

Complement; infant formula; dairy and plant based

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Development of length, BMI, and head circumference

  5 Months + 2 weeks

• Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age

  5 Months + 2 weeks

• Experience of parent and infant

  after using product for 2 and 5 Months

Study Arms (1)

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

Other: Dairy and plant based infant formula feeding

Interventions

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

Infants who started feeding with the product at ≤ 4 months of age

Eligibility Criteria

• Age: Up to 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Ncru, Danone Nutricia Research

Utrecht, 3584CT, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: April 11, 2023
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

NL (1)