Combined Newborn and Lactation Visit for Breastfeeding

(IMPAC Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Medical complications, Pre-term infants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 1 year

246 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Combined Newborn and Lactation Visit for Breastfeeding?

Research shows that integrating breastfeeding care into pediatric practice improves breastfeeding outcomes and enhances the well-being of both mothers and infants. Additionally, using lactation consultants in pediatric practices has been shown to improve breastfeeding duration and support, indicating that combined newborn and lactation visits can be beneficial. ^{1 2 3 4 5}

Is the Combined Newborn and Lactation Visit generally safe for humans?

The available research does not provide specific safety data for the Combined Newborn and Lactation Visit, but there is ongoing effort to study the safety of medications used during lactation, which is relevant to breastfeeding practices. ^{6 7 8 9 10}

How is the Combined Newborn and Lactation Visit treatment different from other treatments for breastfeeding support?

The Combined Newborn and Lactation Visit treatment is unique because it integrates both newborn care and lactation support in a single appointment, allowing for a comprehensive approach to address breastfeeding challenges and newborn health simultaneously. This differs from traditional methods where these services are often provided separately, potentially leading to more coordinated and efficient care for new mothers and their babies. ^{1 5 7 11 12}

What is the purpose of this trial?

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).

Research Team

Karen Myhre

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for new mothers who are breastfeeding. It's designed to see if having a combined appointment with both a newborn checkup and lactation consultation helps improve the start and ongoing success of breastfeeding.

Inclusion Criteria

Mothers with the ability to connect to the internet and complete electronic data collection

Mothers registered as patients at Mayo Clinic Health System Northwest Wisconsin

I am a mother and I am 18 years old or older.

Exclusion Criteria

Mothers with medical complications that could interfere with breastfeeding (e.g., breast reduction)

Mothers who have no intention to breastfeed their newborns

My baby was born before 37 weeks of pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combined lactation and newborn visit or separate visits as per the study arm

1 year

Visits at predefined intervals (e.g., one week, one month, two months, three months, four months, six months, and 12 months postpartum)

Follow-up

Participants are monitored for breastfeeding continuation rates and maternal satisfaction

1 year

Treatment Details

Interventions

• Combined Newborn and Lactation Visit

Trial Overview The study is testing whether combining the first post-hospital visit for the baby with a lactation consultation into one appointment can increase successful breastfeeding at various times up to one year after birth.

Participant Groups

Group I: Combined Lactation and Newborn visit Active Control 1 Intervention

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.

Group II: Separate Lactation and Newborn visit Active Control 1 Intervention

This is current state of care in which a newborn visit is separate and apart from a Lactation Consultation.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The demand for lactation support in primary care has risen, highlighting the importance of pediatric nurse practitioners who can assess both newborns and breastfeeding mothers.

Key factors for successful breastfeeding include good infant weight gain, maternal comfort, and achieving a proper latch, which are essential for effective lactation consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lactation consult: problem solving, teaching, and support for the breastfeeding family. Dann, MH.[2007]

Integrating breastfeeding support into pediatric care leads to better breastfeeding outcomes for infants and increased satisfaction for pediatricians, highlighting the importance of meeting families' expectations.

The focus on optimal care for breastfeeding infants not only promotes healthy physiological and behavioral development but also aligns with preventive health practices in pediatrics, enhancing overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating breastfeeding care into daily newborn rounds and pediatric office practice. Black, LS.[2019]

Newborns who had contact with a health professional within 72 hours of hospital discharge were significantly less likely to be readmitted, indicating that timely follow-up can improve health outcomes.

Mothers who received early postnatal services were less likely to show signs of moderate to severe depression, suggesting that prompt follow-up not only benefits newborn health but also supports maternal mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type and timing of services following postnatal discharge: do they make a difference? Goulet, L., D'Amour, D., Pineault, R.[2015]

Implementing a lactation consultant for initial postpartum visits significantly improved non-formula feeding rates among breastfeeding infants, with an odds ratio of 1.12, indicating a positive impact on breastfeeding support.

The increase in non-formula feeding rates was sustained over the first 9 months after the intervention, showing that structured lactation support can enhance breastfeeding duration and intensity in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating routine lactation consultant support into a pediatric practice. Witt, AM., Smith, S., Mason, MJ., et al.[2021]

The Trifecta Breastfeeding Approach, which includes a pediatrician, lactation consultant, and clinical psychologist, effectively addresses the complex challenges of breastfeeding by focusing on medical care, breastfeeding difficulties, and the mother-infant relationship.

This multidisciplinary model not only improves breastfeeding outcomes but also screens for mood disorders and considers family dynamics, suggesting that integrated care could become more common in healthcare systems as reimbursement for such services increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trifecta approach to breastfeeding: clinical care in the integrated mental health model. Bunik, M., Dunn, DM., Watkins, L., et al.[2014]

The FDA hosted a 2-day workshop focused on the safety of medications used by breastfeeding mothers, aiming to gather data on potential risks to infants.

The discussions emphasized the need for improved data collection methods and future clinical studies to better understand the effects of maternal medication use during lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. Wang, J., Johnson, T., Sahin, L., et al.[2018]

Physician-led breastfeeding medicine clinics in the U.S. provide essential support for breastfeeding-related issues, and those established for over 2 years have shown economic sustainability, indicating their viability as a healthcare model.

Most physicians in these clinics also offer primary care services, suggesting that integrating breastfeeding support into general practice can enhance care and potentially improve breastfeeding duration and exclusivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-led outpatient breastfeeding medicine clinics in the United States. Shaikh, U., Smillie, CM.[2008]

A study analyzing 100 queries from health professionals about drug safety during breastfeeding found that 59% of the evaluated drugs were deemed safe for breastfeeding, indicating that many medications can be used without requiring mothers to stop breastfeeding.

The most frequently asked about drugs included lamotrigine, codeine, quetiapine, and escitalopram, highlighting a particular concern among healthcare providers regarding the safety of medications affecting the nervous system during lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of questions about use of drugs in breastfeeding to Norwegian drug information centres. Jahnsen, JA., Widnes, SF., Schjøtt, J.[2022]

Since 2007, there has been an increase in the number of postmarketing studies required for pregnancy and lactation, but only 16% of new drugs approved for women of reproductive potential were mandated to undergo these studies.

The most common type of required pregnancy safety study was a pregnancy registry, highlighting a significant gap in comprehensive safety data for medications used by pregnant and lactating women, which is essential for informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of pregnancy and lactation postmarketing studies required by the FDA. Krastein, J., Sahin, L., Yao, L.[2023]

Between 2000 and 2022, there was a significant increase in postmarketing commitments (PMCs) and requirements (PMRs) related to pregnancy and lactation for new drugs approved by the FDA, particularly after the enactment of the FDAAA in 2007 and the PLLR in 2015.

Out of 488 new drug applications, 59 included 92 PMCs/PMRs, with a focus on safety data collection for infants and drug concentration measurements in breast milk, highlighting a growing emphasis on understanding the effects of medications on pregnant and lactating women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of the US Food and Drug Administration Post-Marketing Commitments and Requirements for Pregnancy and Lactation. Avachat, C., Younis, IR., Birnbaum, AK.[2023]

Establishing clear written criteria for referring patients to lactation consultants can help identify when new mothers would benefit from specialized breastfeeding support after childbirth.

These criteria are part of a hospital's broader 'Standards of Care for Breastfeeding Families,' ensuring that mothers receive appropriate assistance to promote successful breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A standing order for in-hospital lactation consultation. Shrago, LC.[2019]

Only 21% of the 108 primigravida mothers studied received antenatal counseling on breastfeeding, indicating a significant gap in support for new mothers during pregnancy.

Mothers who received counseling had better awareness about breastfeeding, but overall knowledge about correct techniques and breastfeeding during illness was still lacking, highlighting the need for improved education and support in antenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antenatal counseling on breastfeeding -- is it adequate? A descriptive study from Pondicherry, India. Dhandapany, G., Bethou, A., Arunagirinathan, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The lactation consult: problem solving, teaching, and support for the breastfeeding family. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Incorporating breastfeeding care into daily newborn rounds and pediatric office practice. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Type and timing of services following postnatal discharge: do they make a difference? [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Integrating routine lactation consultant support into a pediatric practice. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Trifecta approach to breastfeeding: clinical care in the integrated mental health model. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Physician-led outpatient breastfeeding medicine clinics in the United States. [2008]

8. England pubmed.ncbi.nlm.nih.gov

Analysis of questions about use of drugs in breastfeeding to Norwegian drug information centres. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A review of pregnancy and lactation postmarketing studies required by the FDA. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Characterization of the US Food and Drug Administration Post-Marketing Commitments and Requirements for Pregnancy and Lactation. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A standing order for in-hospital lactation consultation. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Antenatal counseling on breastfeeding -- is it adequate? A descriptive study from Pondicherry, India. [2022]