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

Infant Growth Clinical Trial

— Complement  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05804214
• Other study ID #: SBB22R&41357
• Status: Terminated
• Start date: April 11, 2023
• Est. completion date: July 14, 2023

Study information

• Verified date: August 2023
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Growth

Intervention

Other:
• 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

Locations

Country	Name	City	State
Netherlands	Ncru, Danone Nutricia Research	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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