Kangaroo Care for Lactation Disorders

(MILK Trial)

Overseen By Kara Kuhn-Riordon, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Recreational drugs, Milk supply enhancers

Disqualifiers: Tandem feeding, Unstable infant, others

Compensation: Varies

Number of Visits: 4

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take any therapies, supplements, or medications that are incompatible with breastfeeding. Additionally, you cannot use any medication specifically to increase milk supply.

What data supports the effectiveness of the treatment Kangaroo Care for lactation disorders?

Research shows that Kangaroo Care, which involves skin-to-skin contact, improves breastfeeding rates and strengthens the bond between parent and child. It has been effective in helping mothers, even in high-risk situations, successfully breastfeed their infants. ^{1 2 3 4 5}

Is kangaroo care safe for humans?

Kangaroo care, also known as skin-to-skin contact, is generally considered safe for both babies and parents. It has been shown to improve clinical outcomes and is safe for use even in high-risk situations, such as with preterm infants or mothers with eclampsia (a condition involving high blood pressure during pregnancy). ^{1 2 6 7 8}

How does the treatment Kangaroo Care differ from other treatments for lactation disorders?

Kangaroo Care is unique because it involves skin-to-skin contact between the mother and baby, which can improve breastfeeding rates and strengthen the bond between them. Unlike other treatments for lactation disorders, it emphasizes natural contact and warmth, rather than medication or mechanical aids. ^{1 2 9 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to learn about the impact of Kangaroo Care (holding your baby skin-to-skin on your chest) in lactating parents with babies in the Neonatal Intensive Care Unit (NICU) that cannot directly breastfeed.

Research Team

Kara Kuhn-Riordon, MD

Principal Investigator

UC Davis

Eligibility Criteria

This trial is for lactating parents with infants in the NICU who plan to provide breast milk for at least a month, can use a hospital pump, and are willing to visit UC Davis NICU four times in ten days. It's not for those feeding multiple infants, using certain drugs or supplements, or whose babies are too unstable for kangaroo care.

Inclusion Criteria

I am a lactating parent and I am 18 years old or older.

Lactating parent is willing to use a hospital grade pump available in the NICU to express milk for sample collection

Doctors, nurses, and other medical staff who are taking care of babies in the MILK study.

Exclusion Criteria

Lactating parents that are participating in an interventional research study that could influence breast milk production

Anyone deemed unfit for participation by the investigator(s)

If you are breastfeeding, you cannot take certain medications or supplements that could harm your baby.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Kangaroo Care Intervention

Participants perform Kangaroo Care and provide breast milk samples for analysis

10 days

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Treatment Details

Interventions

• Kangaroo Care
• No Kangaroo Care

Trial Overview The study examines the effects of Kangaroo Care (skin-to-skin contact) on lactating parents' ability to provide breast milk when their baby cannot directly breastfeed due to being in the NICU.

Participant Groups

Group I: Kangaroo Care Arm (KC) Active Control 1 Intervention

Lactating parents will be asked to arrive at the NICU 2 hours after they have fully expressed their breasts at home and to provide their infants with kangaroo care for 1 hour. Following KC and while still at the infant's bedside, lactating parents will be asked to pump from both of their breasts using a hospital grade pump available in the NICU. Study personnel will weigh the collected milk to determine the total volume of milk expressed by mass. The milk collected from both breasts will be gently swirled six times or more until the fat layer is incorporated in the bottle and will be combined into one bottle. Study personnel will take one 6 mL aliquot from the collected milk for compositional analysis. The remainder of the milk will be saved in the NICU per routine so that it can be fed to the infant later.

Group II: Control Arm (CON) Placebo Group 1 Intervention

Lactating parents will be asked to arrive at the NICU 3 hours after they have fully expressed their breasts at home. Lactating parents will be taken to a private room where they will be asked to pump from both of their breasts using a hospital grade pump available in the NICU. Study personnel will weigh the collected milk to determine the total volume of milk expressed by mass. The milk collected from both breasts will be gently swirled six times or more until the fat layer is incorporated in the bottle and will be combined into one bottle. Study personnel will take one 6 mL aliquot from the collected milk for compositional analysis. The remainder of the milk will be saved in the NICU per routine so that it can be fed to the infant later. Lactating parents will then provide their infants with kangaroo care for 1 hour.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

Kangaroo care (KC) was successfully implemented for a mother with eclampsia who gave birth to a 34-week preterm infant, demonstrating its adaptability in high-risk situations.

The mother was able to breastfeed her infant while practicing KC, highlighting the potential benefits of this method for both maternal and infant health even under challenging circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Birth kangaroo (skin-to-skin) care and breastfeeding. An eclamptic woman's story. Roller, CG., Meyer, K., Anderson, GC.[2022]

Skin-to-skin contact, or kangaroo care, significantly benefits both babies and parents by improving clinical outcomes, temperature regulation, breastfeeding rates, and parent-child bonding, ultimately reducing morbidity and mortality.

Barriers to implementing kangaroo care include insufficient training for nurses and various health issues, but with proper education and support, nurses can effectively advocate for its use, enhancing patient experiences and optimizing clinical time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming the barriers to using kangaroo care in neonatal settings. Penn, S.[2015]

Skin-to-skin contact, or kangaroo mother care (KMC), significantly reduces pain response in very preterm neonates during heel lance procedures, as evidenced by lower Premature Infant Pain Profile (PIPP) scores compared to standard care.

KMC also leads to a shorter recovery time for very preterm infants, with heart rates returning to baseline approximately one minute faster than those in the control group, highlighting its potential benefits in maintaining physiological stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kangaroo mother care diminishes pain from heel lance in very preterm neonates: a crossover trial. Johnston, CC., Filion, F., Campbell-Yeo, M., et al.[2022]

The study developed and evaluated implementation models for Kangaroo Mother Care (KMC) that significantly improved coverage, achieving KMC initiation rates of 68%-86% in Ethiopia and 87% in India for low birth weight infants.

By addressing barriers and adapting strategies based on local context, the study demonstrated that high coverage of KMC can be sustained post-discharge, with 53%-65% of infants receiving KMC at 7 days after leaving the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scaling up Kangaroo Mother Care in Ethiopia and India: a multi-site implementation research study. Mony, PK., Tadele, H., Gobezayehu, AG., et al.[2022]

A systematic review of 1035 articles revealed significant variability in the definitions of Kangaroo Mother Care (KMC), with 29% of studies not providing any definition, highlighting the need for standardization.

Skin-to-skin contact (SSC) was identified as the core component of KMC, while other elements like breastfeeding and early discharge varied by context, suggesting that a unified definition is essential for effective implementation of KMC practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is kangaroo mother care? Systematic review of the literature. Chan, GJ., Valsangkar, B., Kajeepeta, S., et al.[2022]

In a study of 48 full-term infants experiencing breastfeeding difficulties, skin-to-skin contact during breastfeeding helped maintain their body temperatures within the safe thermoneutral range (36.5 to 37.6 degrees C).

The findings suggest that mothers can effectively regulate their infants' temperatures during skin-to-skin contact, providing reassurance to hospital staff and parents about the safety of breastfeeding in this position, regardless of breastfeeding challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newborn temperature during skin-to-skin breastfeeding in couples having breastfeeding difficulties. Chiu, SH., Anderson, GC., Burkhammer, MD.[2007]

Parents reported that holding their infant in a kangaroo position during ground ambulance transport significantly enhanced their sense of closeness and involvement, which is crucial for emotional bonding and parental identity.

The use of kangaroo care during transport not only promotes a positive environment for the baby but also reinforces the importance of parental participation, suggesting that this practice could help minimize separation during neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kangaroo position during neonatal ground ambulance transport: Parents' experiences. Lundqvist, P., Jakobsson, U., Terp, K., et al.[2022]

Kangaroo mother care is a safe and straightforward method for caring for low birth weight infants, emphasizing skin-to-skin contact between the mother and baby.

The implementation of kangaroo mother care has been shown to improve health outcomes for low birth weight infants, highlighting its effectiveness in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kangaroo mother care. Bailey, S.[2019]

Kangaroo mother care (KMC) significantly reduces the risk of mortality and infections in low birthweight (LBW) infants, based on a review of 16 studies involving 2518 infants, making it a promising alternative to conventional neonatal care.

KMC not only decreases hospital stay by an average of 2.4 days but also enhances breastfeeding and mother-infant bonding, suggesting its multifaceted benefits in supporting LBW infants, especially in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Conde-Agudelo, A., Belizán, JM., Diaz-Rossello, J.[2022]

Kangaroo mother care (KMC) significantly reduces the risk of mortality and severe infections in low birthweight (LBW) infants, based on a review of 18 studies involving 2751 infants, making it a promising alternative to conventional neonatal care.

KMC also promotes better growth, breastfeeding, and mother-infant bonding without increasing the risk of neurodevelopmental impairments, suggesting its safety and efficacy in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Conde-Agudelo, A., Díaz-Rossello, JL.[2022]

Kangaroo mother care (KMC) significantly reduces the risk of mortality, infections, and hypothermia in low birthweight infants compared to conventional neonatal care, based on a review of 21 studies involving 3042 infants.

KMC also promotes better growth outcomes, including increased weight gain and breastfeeding rates, making it a beneficial alternative in resource-limited settings for the care of low birthweight infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Conde-Agudelo, A., Díaz-Rossello, JL.[2022]

References

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

Birth kangaroo (skin-to-skin) care and breastfeeding. An eclamptic woman's story. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Overcoming the barriers to using kangaroo care in neonatal settings. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Kangaroo mother care diminishes pain from heel lance in very preterm neonates: a crossover trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Scaling up Kangaroo Mother Care in Ethiopia and India: a multi-site implementation research study. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

What is kangaroo mother care? Systematic review of the literature. [2022]

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

Newborn temperature during skin-to-skin breastfeeding in couples having breastfeeding difficulties. [2007]

7. England pubmed.ncbi.nlm.nih.gov

Kangaroo position during neonatal ground ambulance transport: Parents' experiences. [2022]

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

Kangaroo mother care. [2019]

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

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. [2022]