AllergyNCT05449756
A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life
An observational study of Allergy and Infections, run by Nutricia Research at 1 site in Netherlands.
Trial summary
This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy, Infections
- What is being tested?
- Self-administered questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 705 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 May 2023to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: TEMPO study subjects who completed the final (12 months) visit in the TEMPO study and consented to be approached for follow-up
Who may be able to join
- Subjects are eligible to participate in the TEMPO Follow-Up study in case:
- they completed the final (12 months) visit in the TEMPO study.
- parents agree that their contact details will be shared with a third party for study purposes.
- parents agree that data collected in the TEMPO study will be used in the TEMPO Follow-Up study.
- parents provide written informed consent for participation in the TEMPO Follow-Up in accordance with local law.
Who cannot join
- Parents who do not have a smartphone, tablet or personal computer with internet access.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Danone Nutricia Research Research contact
Netherlands1 site, 1 recruiting
- Recruiting
PreCare Trial & Recruitment
Beek, 6191 JW
Vivienne van de Walle, Dr
About this study
Official title: A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood.
This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.
- Conditions
- Allergy, Infections
- Being tested
- Self-administered questionnaires
- Medical subject headings
- Hypersensitivity, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered questionnairesOther
Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer)
| Study group | Role | What they receive |
|---|---|---|
| Children who participated in randomised clinical trail, called TEMPO, in their first year of life | Children who participated in randomised clinical trail, called TEMPO, in their first year of life Receives: Other: Self-administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-reported symptoms of allergies and infections
The occurrence of parent-reported - symptoms suggestive of allergies and infections
Measured: 7.5 years
Parent-reported use of medications and/or a medical device
The occurrence of parent-reported - use of medications and/or a medical device to prevent or relieve symptoms suggestive of allergies and infections
Measured: 7.5 years
Parent-reported - hospitalisations and visits to the emergency room
The occurrence of parent-reported - hospitalisations and visits to the emergency room for symptoms suggestive of allergies and infections
Measured: 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start30 May 2023
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
- 705 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449756
- Sponsor's protocol ID
- EBB18TA23570
- Status last verified
- Dec 2023
- First submitted
- 4 Jul 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood.
- ClinicalTrials.gov ID
- NCT05449756
- Acronym / sponsor ID
- EBB18TA23570
- Conditions
- Allergy, Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 705 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 8 Jul 2022 (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.
This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children who participated in randomised clinical trail, called TEMPO, in their first year of life | – | Other: Self-administered questionnairesChildren who participated in randomised clinical trail, called TEMPO, in their first year of life |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- TEMPO study subjects who completed the final (12 months) visit in the TEMPO study and consented to be approached for follow-up
Key inclusion criteria (5 listed)
- Subjects are eligible to participate in the TEMPO Follow-Up study in case:
- they completed the final (12 months) visit in the TEMPO study.
- parents agree that their contact details will be shared with a third party for study purposes.
- parents agree that data collected in the TEMPO study will be used in the TEMPO Follow-Up study.
- parents provide written informed consent for participation in the TEMPO Follow-Up in accordance with local law.
Key exclusion criteria (1 listed)
- Parents who do not have a smartphone, tablet or personal computer with internet access.
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 |
|---|---|---|
| Self-administered questionnairesThree-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer) | Other | Children who participated in randomised clinical trail, called TEMPO, in their first year of life |
Primary outcome
Parent-reported symptoms of allergies and infections
Time frame: 7.5 years
The occurrence of parent-reported - symptoms suggestive of allergies and infections
Parent-reported use of medications and/or a medical device
Time frame: 7.5 years
The occurrence of parent-reported - use of medications and/or a medical device to prevent or relieve symptoms suggestive of allergies and infections
Parent-reported - hospitalisations and visits to the emergency room
Time frame: 7.5 years
The occurrence of parent-reported - hospitalisations and visits to the emergency room for symptoms suggestive of allergies and infections
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Danone Nutricia Research Research contact
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 Allergy and Infections, 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danone Nutricia Research Research (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-reported symptoms of allergies and infections (time frame: 7.5 years). The study lists 3 primary outcomes in all. 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 11 Dec 2023.