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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05804214
Other study ID # SBB22R&41357
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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