Thermoses as a Way to Provide Human Milk to Toddlers in D... | NCT07540871

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

NCT07540871

Sponsor

University of Florida

Status

Not yet recruiting

Last Update Posted

May 8, 2026Actual

Enrollment

15Estimated

Phase

Not Applicable

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

Interventions

Thermos 1
Thermos 2
Thermos 3

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Nov 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Apr 14, 2026

First Submission Date that Met QC Criteria

Apr 14, 2026

First Posted Date

Apr 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Conditions Module

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

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thermos 1	Other	First of three study thermoses	Other: Thermos 1
Thermos #2	Other	Second of three study thermoses	Other: Thermos 2
Thermos #3	Other	Third of three study thermoses	Other: Thermos 3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thermos 1	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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	Weekly questionnaires for 12 weeks
Parent report of thermos problems

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diana H Taft, PhD	Contact	352-294-3755		dianataft@ufl.edu

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Informed Consent Form (ICF)
Analytic Code

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

Access Criteria

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

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Intervention 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.