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Not yet recruiting NCT07540871

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

No phase Interventional 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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thermos 1, Thermos 2, Thermos 3.
Who it may be relevant to
Registry 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. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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
    This is the second of the three thermoses used in the study
  • Other Thermos 3
    This is the third of the three different thermoses

Primary outcome measures

  • Breastmilk temperature at lunch [Time frame: Measured daily for 4 weeks]
  • Breastmilk temperature at afternoon snack [Time frame: Measured daily for 4 weeks]
Secondary outcome measures (2)
  • 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]

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07540871 · IRB202600459

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗