Breast FeedingIMPACNCT06395168
Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination
A study testing Combined Newborn and Lactation Visit in people with Breast Feeding, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to explore whether combining the first post-hospital newborn provider visit and lactation consultation into a single appointment can enhance rates of successful breastfeeding initiation and continuation at predefined intervals (e.g., one week, one month, two months, three months, four… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Combined Newborn and Lactation Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers aged greater than or equal to 18 years.
- Mothers who are able to provide informed consent for participation in this study.
- Mothers registered as patients at Mayo Clinic Health System Northwest Wisconsin.
- Mothers who have given birth within the past four days prior to enrollment into this study.
- Mothers who intend to breastfeed their newborns.
- Mothers who are willing and able to participate in this study.
- Mothers who are able to communicate in English.
- Mothers with the ability to connect to the internet and complete electronic data collection.
Who cannot join
- Mothers who are unable or unwilling to provide informed consent for participation in this study.
- Mothers less than 18 years of age.
- Mothers unable to complete study procedures or follow-up visits.
- Mothers with medical complications that could interfere with breastfeeding (e.g., breast reduction).
- Mothers who have no intention to breastfeed their newborns.
- Mothers who are unwilling to follow up with lactation.
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- Infants who have already had their first postpartum outpatient provider visit.
- Pre-term infants (less than 37 weeks).
- Special care admission greater than two days.
- Length of stay or anticipated LOS greater than four days.
- Transfer to an outside facility.
- Inability to communicate in English.
- When slots are no longer available.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54703
About this study
Official title: IMPAC: Integrated Maternal Postpartum Appointment Combination in Mayo Clinic Health System Northwest Wisconsin
The purpose of this study is to explore whether combining the first post-hospital newborn provider visit and lactation consultation into a single appointment can enhance rates of successful breastfeeding initiation and continuation at predefined intervals (e.g., one week, one month, two months, three months, four months, six months, and 12 months postpartum).
Read the detailed description
This interventional, comparative effectiveness study investigates the impact of integrating the first newborn outpatient provider and lactation consultant visits, potentially reducing appointments for new mothers while ensuring early lactation support. The outcomes, including breastfeeding continuation rates and maternal satisfaction, will be measured against the conventional separate visit model. The ultimate goal is to prolong breastfeeding duration, enhance care quality, improve efficiency, and enrich patient experience.
- Conditions
- Breast Feeding
- Being tested
- Combined Newborn and Lactation Visit
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Newborn and Lactation VisitOther
See Arm/Group Description
| Study group | Role | What they receive |
|---|---|---|
| Combined Lactation and Newborn visit | Active comparator | This arm is the intervention where the newborn visit with the pediatric provider is within a lactation consultant visit for a breastfeeding newborn and mother. Receives: Other: Combined Newborn and Lactation Visit |
| Separate Lactation and Newborn visit | No intervention | This is current state of care in which a newborn visit is separate and apart from a Lactation Consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits.
Looking for the difference of breastfeeding continuation between the intervention and control group. Hypothesis is higher breastfeeding rates in the combined lactation/newborn visit.
Measured: Duration of the study (expected 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start19 Aug 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa A. Thompson, Mayo Clinic
- Investigators
- Melissa Thompson, CNP, DNP, APNP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395168
- Sponsor's protocol ID
- 23-012862
- Acronym
- IMPAC
- Status last verified
- Nov 2025
- First submitted
- 29 Apr 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPAC: Integrated Maternal Postpartum Appointment Combination in Mayo Clinic Health System Northwest Wisconsin
- ClinicalTrials.gov ID
- NCT06395168
- Acronym / sponsor ID
- IMPAC / 23-012862
- Conditions
- Breast Feeding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 May 2024 (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.
The purpose of this study is to explore whether combining the first post-hospital newborn provider visit and lactation consultation into a single appointment can enhance rates of successful breastfeeding initiation and continuation at predefined intervals (e.g., one week, one month, two months, three months, four months, six months, and 12 months postpartum).
Detailed description
This interventional, comparative effectiveness study investigates the impact of integrating the first newborn outpatient provider and lactation consultant visits, potentially reducing appointments for new mothers while ensuring early lactation support. The outcomes, including breastfeeding continuation rates and maternal satisfaction, will be measured against the conventional separate visit model. The ultimate goal is to prolong breastfeeding duration, enhance care quality, improve efficiency, and enrich patient experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Lactation and Newborn visit | Active comparator | Other: Combined Newborn and Lactation VisitThis arm is the intervention where the newborn visit with the pediatric provider is within a lactation consultant visit for a breastfeeding newborn and mother. |
| Separate Lactation and Newborn visit | No intervention | –This is current state of care in which a newborn visit is separate and apart from a Lactation Consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mothers aged greater than or equal to 18 years.
- Mothers who are able to provide informed consent for participation in this study.
- Mothers registered as patients at Mayo Clinic Health System Northwest Wisconsin.
- Mothers who have given birth within the past four days prior to enrollment into this study.
- Mothers who intend to breastfeed their newborns.
Key exclusion criteria (13 listed)
- Mothers who are unable or unwilling to provide informed consent for participation in this study.
- Mothers less than 18 years of age.
- Mothers unable to complete study procedures or follow-up visits.
- Mothers with medical complications that could interfere with breastfeeding (e.g., breast reduction).
- Mothers who have no intention to breastfeed their newborns.
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 |
|---|---|---|
| Combined Newborn and Lactation VisitSee Arm/Group Description | Other | Combined Lactation and Newborn visit |
Primary outcome
Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits.
Time frame: Duration of the study (expected 1 year)
Looking for the difference of breastfeeding continuation between the intervention and control group. Hypothesis is higher breastfeeding rates in the combined lactation/newborn visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Melissa Thompson, CNP, DNP, APNP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Newborn and Lactation Visit in people with Breast Feeding, run by Mayo Clinic 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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits. (time frame: Duration of the study (expected 1 year)). 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 24 Jun 2026.