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

August 3, 2023 updated by: Nutricia Research
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of weight, length, and head circumference
Time Frame: 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
5 Months +2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of length, BMI, and head circumference
Time Frame: 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)
5 Months + 2 weeks
Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age
Time Frame: 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)
5 Months + 2 weeks
Experience of parent and infant
Time Frame: 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
after using product for 2 and 5 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2023

Primary Completion (Actual)

July 14, 2023

Study Completion (Actual)

July 14, 2023

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SBB22R&41357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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