Thermoses as a Way to Provide Human Milk to Toddlers in Daycare

May 5, 2026 updated by: University of Florida
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

-

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Thermos 1
First of three study thermoses
Other: Thermos 1
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.
Other: Thermos #2
Second of three study thermoses
Other: Thermos 2
This is the second of the three thermoses used in the study
Other: Thermos #3
Third of three study thermoses
Other: Thermos 3
This is the third of the three different thermoses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breastmilk temperature at lunch
Time Frame: Measured daily for 4 weeks
Measured daily for 4 weeks
Breastmilk temperature at afternoon snack
Time Frame: Measured daily for 4 weeks
Measured daily for 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daycare provider report of thermos problems
Time Frame: Weekly questionnaires for 12 weeks
Daycare providers will be asked to report using a scale listed as no issues, minor issues, moderate issues, and severe issues
Weekly questionnaires for 12 weeks
Parent report of thermos problems
Time Frame: Measured weekly for 12 weeks
Parents will be asked to report using a scale listed as no issues, minor issues, moderate issues, and severe issues
Measured weekly for 12 weeks

Collaborators and Investigators

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

Sponsor

University of Florida

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB202600459

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share deidentified responses to weekly questionnaires when results are published

IPD Sharing Time Frame

We will make IPD available on publication by sharing de-identified results as supplemental information to publications. A blank consent will be available to the journal on request, for as long as the PI is required to maintain such records. Analytical code will be made available upon publication

IPD Sharing Access Criteria

IPD will be to those who can access the de-identified data as part of the publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

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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