Infant GrowthComplementNCT05804214
Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
An observational study of Infant Growth and Parent and Infant User Experience, run by Nutricia Research at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages Up to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Growth, Parent and Infant User Experience
- What is being tested?
- Dairy and plant based infant formula feeding
- How many people
- 2 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Apr 2023to 14 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infant Growth, Parent and Infant User Experience
- Being tested
- Dairy and plant based infant formula feeding
- Keywords
- Complement, infant formula, dairy and plant based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy and plant based infant formula feedingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Dairy and plant based infant formula feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 Months +2 weeks
Secondary outcomes (3)
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)
Measured: 5 Months + 2 weeks
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)
Measured: 5 Months + 2 weeks
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
Measured: after using product for 2 and 5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start11 Apr 2023
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Why it stopped: Study early terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant GrowthStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804214
- Sponsor's protocol ID
- SBB22R&41357
- Acronym
- Complement
- Status last verified
- Aug 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
- ClinicalTrials.gov ID
- NCT05804214
- Acronym / sponsor ID
- Complement / SBB22R&41357
- Conditions
- Infant Growth, Parent and Infant User Experience
- Keywords
- Complement, infant formula, dairy and plant based
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study early terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants who started feeding with the product at ≤ 4 months of age | – | Other: Dairy and plant based infant formula feedingInfants who started feeding with the product at ≤ 4 months of age, either supplemental to breastfeeding or as sole source of feeding |
Who may qualify
- Ages
- Up to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy and plant based infant formula feedingParents 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 | Other | Infants who started feeding with the product at ≤ 4 months of age |
Primary outcome
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
3 secondary outcomes
Development of length, BMI, and head circumference
Time frame: 5 Months + 2 weeks
Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age
Time frame: 5 Months + 2 weeks
Experience of parent and infant
Time frame: after using product for 2 and 5 Months
Results and safety
The study was stopped early (reason given: Study early terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Growth and Parent and Infant User Experience, run by Nutricia Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study early terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of weight, length, and head circumference (time frame: 5 Months +2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.