Parents of Toddlers in Daycare Who Wish to Continue to Provide Breastmilk Past the Age of 1 YearNCT07540871
Thermoses as a Way to Provide Human Milk to Toddlers in Daycare
A study testing Thermos 1, Thermos 2 and Thermos 3 in people with Parents of Toddlers in Daycare Who Wish to Continue to Provide Breastmilk Past the Age of 1 Year and Daycare Providers Working With Children Between the Ages of 1 and 3 Years Who Still Receive Breastmilk, run by University of Florida.
Trial summary
Parents and daycare providers for children between the ages of 1 and 3 years old at participating daycares will be asked to join this study. Parents will be provided with three thermoses designed to keep breastmilk at a safe temperature for 15+ hours, and asked to use each thermos for four weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parents of Toddlers in Daycare Who Wish to Continue to Provide Breastmilk Past the Age of 1 Year, Daycare Providers Working With Children Between the Ages of 1 and 3 Years Who Still Receive Breastmilk
- What is being tested?
- Thermos 1, Thermos 2 and Thermos 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2027
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must work at a participating daycare OR send a child to a participating daycare
- Must work with children between the ages of 1 and 3 years at least 3 days a week, with at least 1 participating child in the classroom (daycare providers)
- Must intend to provide breastmilk to a child ages 1 to 3 years for lunch and/or afternoon snack (parent)
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Parents and daycare providers for children between the ages of 1 and 3 years old at participating daycares will be asked to join this study. Parents will be provided with three thermoses designed to keep breastmilk at a safe temperature for 15+ hours, and asked to use each thermos for four weeks. Parents and daycare providers will be asked to complete weekly questionnaires about any problems they experience with a thermos. Study staff will check the temperature of the milk each day before lunch and afternoon snack to ensure the milk is at a safe temperature for consumption.
- Conditions
- Parents of Toddlers in Daycare Who Wish to Continue to Provide Breastmilk Past the Age of 1 Year, Daycare Providers Working With Children Between the Ages of 1 and 3 Years Who Still Receive Breastmilk
- Being tested
- Thermos 1, Thermos 2, Thermos 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermos 1Other
Parents will be provided with 3 different thermoses, all marketed as capable of keeping breastmilk at a safe temperature for 15 or more hours. The interventions are numbered to match study assigned thermos number.
Thermos 2Other
This is the second of the three thermoses used in the study
Thermos 3Other
This is the third of the three different thermoses
| Study group | Role | What they receive |
|---|---|---|
| Thermos 1 | Other | First of three study thermoses Receives: Other: Thermos 1 |
| Thermos #2 | Other | Second of three study thermoses Receives: Other: Thermos 2 |
| Thermos #3 | Other | Third of three study thermoses Receives: Other: Thermos 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk temperature at lunch
Measured: Measured daily for 4 weeks
Breastmilk temperature at afternoon snack
Measured: Measured daily for 4 weeks
Secondary outcomes (2)
Daycare provider report of thermos problems
Daycare providers will be asked to report using a scale listed as no issues, minor issues, moderate issues, and severe issues
Measured: Weekly questionnaires for 12 weeks
Parent report of thermos problems
Parents will be asked to report using a scale listed as no issues, minor issues, moderate issues, and severe issues
Measured: Measured weekly for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parents of Toddlers in Daycare Who Wish to Continue to Provide Breastmilk Past the Age of 1 YearStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parents will be asked to use each of the three provided thermoses for four weeks, in a randomly assigned order. Study staff will visit daycares daily to ensure that the breastmilk is kept at a safe temperature prior to lunch and afternoon snack, milk that is too warm will be discarded. Parents and daycare providers will complete weekly questionnaires on any problems associated with the thermoses in the past week.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540871
- Sponsor's protocol ID
- IRB202600459
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share deidentified responses to weekly questionnaires when results are published
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermoses as a Way to Provide Human Milk to Toddlers in Daycare
- ClinicalTrials.gov ID
- NCT07540871
- Acronym / sponsor ID
- IRB202600459
- Conditions
- Parents of Toddlers in Daycare Who Wish to Continue to Provide Breastmilk Past the Age of 1 Year, Daycare Providers Working With Children Between the Ages of 1 and 3 Years Who Still Receive Breastmilk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Apr 2026 (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.
Parents and daycare providers for children between the ages of 1 and 3 years old at participating daycares will be asked to join this study. Parents will be provided with three thermoses designed to keep breastmilk at a safe temperature for 15+ hours, and asked to use each thermos for four weeks. Parents and daycare providers will be asked to complete weekly questionnaires about any problems they experience with a thermos. Study staff will check the temperature of the milk each day before lunch and afternoon snack to ensure the milk is at a safe temperature for consumption.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parents will be asked to use each of the three provided thermoses for four weeks, in a randomly assigned order. Study staff will visit daycares daily to ensure that the breastmilk is kept at a safe temperature prior to lunch and afternoon snack, milk that is too warm will be discarded. Parents and daycare providers will complete weekly questionnaires on any problems associated with the thermoses in the past week.
| Arm | Type | Receives |
|---|---|---|
| Thermos 1 | Other | Other: Thermos 1First of three study thermoses |
| Thermos #2 | Other | Other: Thermos 2Second of three study thermoses |
| Thermos #3 | Other | Other: Thermos 3Third of three study thermoses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must work at a participating daycare OR send a child to a participating daycare
- Must work with children between the ages of 1 and 3 years at least 3 days a week, with at least 1 participating child in the classroom (daycare providers)
- Must intend to provide breastmilk to a child ages 1 to 3 years for lunch and/or afternoon snack (parent)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Thermos 1Parents will be provided with 3 different thermoses, all marketed as capable of keeping breastmilk at a safe temperature for 15 or more hours. The interventions are numbered to match study assigned thermos number. | Other | Thermos 1 |
| Thermos 2This is the second of the three thermoses used in the study | Other | Thermos #2 |
| Thermos 3This is the third of the three different thermoses | Other | Thermos #3 |
Primary outcome
Breastmilk temperature at lunch
Time frame: Measured daily for 4 weeks
Breastmilk temperature at afternoon snack
Time frame: Measured daily for 4 weeks
2 secondary outcomes
Daycare provider report of thermos problems
Time frame: Weekly questionnaires for 12 weeks
Parent report of thermos problems
Time frame: Measured weekly for 12 weeks
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 8 May 2026.
- Individual participant dataSharing planned: Yes. We will share deidentified responses to weekly questionnaires when results are published
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.
Questions about this trial
What is this clinical trial studying?
A study testing Thermos 1, Thermos 2 and Thermos 3 in people with Parents of Toddlers in Daycare Who Wish to Continue to Provide Breastmilk Past the Age of 1 Year and Daycare Providers Working With Children Between the Ages of 1 and 3 Years Who Still Receive Breastmilk, run by University of Florida.
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 3 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: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Diana H Taft, PhD (352-294-3755, dianataft@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastmilk temperature at lunch (time frame: Measured daily for 4 weeks). The study lists 2 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 8 May 2026.