ClinicalTrials.gg
CompletedNCT04519216Updated Apr 23, 2025

Breastfeeding Education in the Time of COVID-19

An interventional study of Telesimulation in Breastfeeding, Breastfeeding, Exclusive and Breastfeeding Jaundice, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-23.

Sponsored by University of California, Davis · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Breast Feeding by University of California, Davis — 1 open to participants now, 3 under way, none of them phase 3. Breast Feeding · University of California, Davis.

Enrollment
8th of 11
46 · median 102
Started
2020
the only one that year
No phase
11 of 13
none open now
Registered
10th of 13
by date

Among the 13 studies in Breast Feeding by University of California, Davis, this one is the 8th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2020, is one of 11 with no phase, and was the 10th registered.

Breast Feeding

1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.

Browse Breast Feeding studies →

Open to participants now

1 of the 13 studies in Breast Feeding by University of California, Davis is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Breast Feeding by University of California, Davis, or all of them as a file.
02

Study summary

This project will establish that pediatric and family medicine residents who complete a hybrid breastfeeding medicine curriculum that includes an asynchronous unfolding case scenario along with telesimulation with a standardized patient (SP) will provide timely, skilled lactation support more frequently than residents randomized to an asynchronous unfolding case scenario followed by videoconference group discussion regarding care for the breastfeeding dyad.

Read the detailed description
  1. Establish that pediatric and family medicine residents who complete a novel breastfeeding medicine curriculum that includes an online unfolding case scenario along with telemedicine simulation with a standardized patient (SP) will provide timely, skilled lactation support more frequently than residents randomized to an online unfolding case scenario followed by traditional didactic breastfeeding case-presentation via videoconference.
  2. Establish that online learning via unfolding case scenario and telemedicine simulation with a SP will be feasible for family medicine and pediatric residents to complete during their newborn nursery rotation.

Intern and third year residents completing their newborn nursery rotation at UC Davis Medical Center will be cluster-randomized by rotation month to receipt of breastfeeding education via telesimulation with standardized patient or traditional case-based learning via videoconferencing with pediatric faculty. The primary outcome of this study will be the translation of clinical lactation skills to the care of breastfeeding mothers and newborns. I hypothesize that pediatric and family medicine residents randomized to complete the telesimulation with SP will translate their acquired clinical lactation skills to the care of breastfeeding mothers and newborns at a greater rate than residents who complete a videoconference case-based traditional curriculum discussion with a newborn nursery pediatrician.

03

Conditions studied

  • Breastfeeding
  • Breastfeeding, Exclusive
  • Breastfeeding Jaundice
  • Educational Problems

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  1. Inclusion Criteria: Pediatric and Family Medicine resident physicians at UC Davis Medical Center
  2. Exclusion criteria: Individuals who are unable to communicate in English, Individuals who do not have access to videoconferencing via computer or phone.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Traditional education

    Participants in the control group will complete an online unfolding case scenario. Then these same participants will participate in a videoconferencing case based lecture with the academic pediatric fellow

    Behavioral: Telesimulation

  • Experimental
    Telesimulation

    Participants in the intervention group will complete an online unfolding case scenario. Then these participants will complete a telesimulation case with a standardized patient via video conferencing.

    Behavioral: Telesimulation

Interventions

  • BehavioralTelesimulation

    Telesimulation educational intervention

06

What researchers measure

Primary outcomes

  1. Change in practice patterns

    Breastfeeding medicine practice patterns of physician residents will be assessed at enrollment and following the intervention/control. Physician resident participants will complete a survey querying the number of times they have counseled patients about breastfeeding, the number of breast examinations performed, the number of witnessed breastfeeding sessions, and any experience with counseling about manual expression of breast milk.

    Time frame: at enrollment, 2 weeks and 3 months following intervention

Secondary outcomes

  1. Self efficacy

    Physician residents (participants) will fill out a survey about their breastfeeding counseling self efficacy prior to and after the intervention.

    Time frame: at enrollment, 2 weeks and 3 months following intervention

  2. Satisfaction with simulation

    Physician residents (participants) will fill out a survey about their satisfaction with the breast feeding medicine curriculum after the educational intervention.

    Time frame: Immediately following the educational intervention

07

Study locations

1 site
  • University of California - Davis
    Sacramento, California 95817, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Oct 2021, 14 months.

Of 503 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 14 months is above that.

Counting every sponsor, half of 511 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2020
First posted
Aug 19, 2020
StartActual
Jul 31, 2020
Primary completionActual
Oct 30, 2021
CompletionActual
Dec 10, 2021
Last update
Apr 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04519216
Responsible party
Sponsor
First posted
Aug 19, 2020
Start date
Jul 31, 2020
Primary completion
Oct 30, 2021
Completion
Dec 10, 2021
Last update
Apr 23, 2025

Study contacts

Adrienne Hoyt-Austin, DO
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion