BreastfeedingNCT04715724
Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment
A study testing Positioning and Attachment video-based simulation (telesimulation) in people with Breastfeeding and Patient Simulation, run by LiquidGoldConcept at 1 site in United States.
Trial summary
In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Patient Simulation, High Fidelity Simulation Training
- What is being tested?
- Positioning and Attachment video-based simulation (telesimulation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Received IBCLC, CLC, FABM, or similar certification in clinical lactation
- At least 2 years professional experience with breastfeeding patients
- Work with lactating patients/clients at least monthly
- Work with positioning and attachment at least weekly
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment in a Clinical Lactation Telesimulation
In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment. Study participants will interact with a standardized patient educator (SP) wearing the Lactation Simulation Model and using two baby dolls in a randomized order.
Read the detailed description
Identifying signs of effective newborn positioning and attachment is an essential skill for maternal-child care providers. No study has evaluated the effectiveness of commonly used baby dolls for teaching this skill. In this comparison study, clinical lactation specialists will be randomly assigned two baby dolls to evaluate in two back-to-back video-based simulations (telesimulations) with a standardized patient wearing the LiquidGoldConcept Lactation Simulation Model. Participants will complete a novel competency assessment using 3-second video clips to show specific components of positioning and attachment and evaluating whether any correction is needed and why or why not.
- Being tested
- Positioning and Attachment video-based simulation (telesimulation)
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning and Attachment video-based simulation (telesimulation)Other
Participants will teach a standardized patient actor (SP) to position and attach the baby doll at the breast of the Lactation Simulation Model in a video-based simulation (telesimulation)
| Study group | Role | What they receive |
|---|---|---|
| Baby doll with remote controlled jaw | Experimental | In this arm, participants will complete a simulation using the Newborn Oral Assessment and Latch Simulator (NORALSim), which is designed to look, feel, and weigh like a healthy human newborn. The NORALSim's jaw can be remotely operated by the user to demonstrate attachment at the breast. Receives: Other: Positioning and Attachment video-based simulation (telesimulation) |
| Baby doll with hand controlled jaw | Active comparator | In this arm, participants will complete a simulation using a cloth baby with a puppet-style jaw which can be opened and closed by the user to demonstrate attachment at the breast. Receives: Other: Positioning and Attachment video-based simulation (telesimulation) |
| Static baby doll | Active comparator | In this arm, participants will complete a simulation using a rigid, plastic baby with a static, open mouth. Receives: Other: Positioning and Attachment video-based simulation (telesimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Skills Confirmation
Participants will confirm or deny whether they were able to teach specific components of newborn positioning and attachment with the baby doll.
Measured: Day 1
Secondary outcomes (2)
Relative realism of baby doll
Participants will be asked to compare the realism of the two baby dolls used in their simulation on a 30-point checklist. Respondent will rank the two baby dolls' ability to demonstrate specific components of positioning and attachment.
Measured: Day 1
Satisfaction with baby dolls
Participants will participate in a 10-minute semi-structured interview immediately following the simulations and discuss what worked and didn't work about each baby doll for teaching newborn positioning and attachment. Interviews will be transcribed and thematically analyzed to report participant satisfaction/dissatisfaction with the baby dolls.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Feb 2021
- Primary completion15 Feb 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- All participants will evaluate the Newborn Oral Assessment and Latch Simulator (NORALSim) and one of two other baby dolls: 1) a cloth doll with a puppet-style head where the user can control the opening and closing of the mouth, and 2) a rigid, plastic doll with a static open mouth. The order of presentation of the dolls between the two back-to-back simulations and the second baby doll will be randomized.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- LiquidGoldConcept
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715724
- Sponsor's protocol ID
- 21-001
- Status last verified
- Apr 2021
- First submitted
- 5 Jan 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be aggregated for data analysis and publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment in a Clinical Lactation Telesimulation
- ClinicalTrials.gov ID
- NCT04715724
- Acronym / sponsor ID
- 21-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- LiquidGoldConceptIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 20 Jan 2021 (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.
In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment. Study participants will interact with a standardized patient educator (SP) wearing the Lactation Simulation Model and using two baby dolls in a randomized order.
Detailed description
Identifying signs of effective newborn positioning and attachment is an essential skill for maternal-child care providers. No study has evaluated the effectiveness of commonly used baby dolls for teaching this skill. In this comparison study, clinical lactation specialists will be randomly assigned two baby dolls to evaluate in two back-to-back video-based simulations (telesimulations) with a standardized patient wearing the LiquidGoldConcept Lactation Simulation Model. Participants will complete a novel competency assessment using 3-second video clips to show specific components of positioning and attachment and evaluating whether any correction is needed and why or why not.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All participants will evaluate the Newborn Oral Assessment and Latch Simulator (NORALSim) and one of two other baby dolls: 1) a cloth doll with a puppet-style head where the user can control the opening and closing of the mouth, and 2) a rigid, plastic doll with a static open mouth. The order of presentation of the dolls between the two back-to-back simulations and the second baby doll will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Baby doll with remote controlled jaw | Experimental | Other: Positioning and Attachment video-based simulation (telesimulation)In this arm, participants will complete a simulation using the Newborn Oral Assessment and Latch Simulator (NORALSim), which is designed to look, feel, and weigh like a healthy human newborn. The NORALSim's jaw can be remotely operated by the user to demonstrate attachment at the breast. |
| Baby doll with hand controlled jaw | Active comparator | Other: Positioning and Attachment video-based simulation (telesimulation)In this arm, participants will complete a simulation using a cloth baby with a puppet-style jaw which can be opened and closed by the user to demonstrate attachment at the breast. |
| Static baby doll | Active comparator | Other: Positioning and Attachment video-based simulation (telesimulation)In this arm, participants will complete a simulation using a rigid, plastic baby with a static, open mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Received IBCLC, CLC, FABM, or similar certification in clinical lactation
- At least 2 years professional experience with breastfeeding patients
- Work with lactating patients/clients at least monthly
- Work with positioning and attachment at least weekly
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Positioning and Attachment video-based simulation (telesimulation)Participants will teach a standardized patient actor (SP) to position and attach the baby doll at the breast of the Lactation Simulation Model in a video-based simulation (telesimulation) | Other | Baby doll with hand controlled jaw, Baby doll with remote controlled jaw, Static baby doll |
Primary outcome
Technical Skills Confirmation
Time frame: Day 1
Participants will confirm or deny whether they were able to teach specific components of newborn positioning and attachment with the baby doll.
2 secondary outcomes
Relative realism of baby doll
Time frame: Day 1
Satisfaction with baby dolls
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No. Data will be aggregated for data analysis and publication.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning and Attachment video-based simulation (telesimulation) in people with Breastfeeding and Patient Simulation, run by LiquidGoldConcept at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Skills Confirmation (time frame: Day 1). 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 5 Apr 2021.