Infant Carrier for Postpartum Health

Overseen By R. Aver Yakubu, MHA, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nurturely

Disqualifiers: Under 18, Multiple births, others

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

Compensation: Varies

Number of Visits: 7

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Suboptimal postpartum health outcomes in the US, including low rates of lactation and high rates of postpartum depression, contribute to high rates of perinatal mortality and morbidity as well as long-term and intergenerational health outcomes. Black birthing parents and infants are at the highest risk, with the lowest rates of lactation and the highest rates of postpartum depression. Yet most interventions to support lactation and postpartum mental health are based on models of care that are unrepresentative of Black and global majority communities. The principal investigator's previous Randomized Controlled Trial (RCT) using soft infant carriers to increase parent-infant physical contact was effective in increasing lactation and decreasing postpartum depression in a sample of Latinx postpartum parents. Infant carrying, or "babywearing," is a culturally relevant prevention strategy based on models of parenting representative of Black and global majority communities. In this study, the investigators use strategies from implementation research and clinical effectiveness research to assess an infant carrier intervention within a community-based, culturally specific perinatal home visiting program for Black birthing parents.

Will I have to stop taking my current medications?

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

Is it safe to use infant carriers like slings and harnesses?

While infant carriers like slings and harnesses are popular and generally considered safe, there have been reports of sudden unexpected deaths in infants, often due to suffocation. It's important to use these carriers correctly and ensure the baby's face is visible and not pressed against fabric or the caregiver's body to prevent breathing issues. ^{1 2 3 4 5}

How does the infant carrier treatment differ from other postpartum health treatments?

The infant carrier treatment is unique because it involves using a baby carrier to promote postpartum health, which is different from traditional medical or pharmaceutical interventions. This approach focuses on the physical closeness and bonding between the caregiver and infant, which can support emotional well-being and potentially improve postpartum recovery. ^{5 6 7 8 9}

Eligibility Criteria

This trial is for Black birthing parents who are over 18, currently pregnant with one baby, fluent in a study language, have internet access via smartphone, an email account, and can physically and mentally use an infant carrier. They must be part of a participating agency.

Inclusion Criteria

Currently pregnant with a singleton pregnancy

I am 18 years old or older.

I can physically and mentally manage an infant carrier, follow the study's instructions, and keep records of my participation.

Exclusion Criteria

Cannot use an infant carrier

No working email

I am younger than 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Training

Participants in the intervention group receive training on using the infant carrier around 37 weeks gestation

1 week

1 visit (in-person)

Postpartum Intervention

Participants use the infant carrier to increase physical contact with infants, supported by home visitation

24 weeks

Regular home visits

Follow-up

Participants are monitored for lactation and postpartum depression outcomes

52 weeks

Follow-up assessments at weeks 6, 12, 24, and 52

Treatment Details

Interventions

• Infant Carrier

Trial Overview The trial tests whether using soft infant carriers increases lactation rates and decreases postpartum depression among Black birthing parents. It's based on previous successful trials in Latinx communities and integrates culturally specific care within perinatal home visiting programs.

Participant Groups

Group I: Infant Carrier Experimental Treatment 1 Intervention

In the intervention group, in the prenatal period (\~37 weeks gestation) will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client in practicing using the carrier and will provide materials to support continued learning.

Group II: Infant Carrier Waitlist Active Control 1 Intervention

Participants assigned to the waitlist control will receive home visitation care as usual. At 6-months postpartum they will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client in practicing using the carrier and will provide materials to support continued learning.

Who Is Running the Clinical Trial?

Nurturely

Lead Sponsor

Trials

2

Recruited

500+

Findings from Research

A study involving 36 newborns (24 preterm and 12 term) found that carrying infants in slings does not lead to clinically significant changes in oxygen saturation or heart rate, indicating safety in this practice.

While there was a slight decrease in oxygen saturation when infants were carried in slings compared to lying in a pram, these changes were not clinically relevant, and any episodes of desaturation or bradycardia were only observed in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory stability of premature and term infants carried in infant slings. Stening, W., Nitsch, P., Wassmer, G., et al.[2019]

A report of 19 cases of sudden unexpected death in infancy (SUDI) linked to soft infant carriers highlights that these carriers can pose a significant risk of suffocation, particularly in healthy full-term babies under 3 months old.

The findings suggest that infant carriers are an underestimated cause of suffocation-related deaths in neonates, emphasizing the need for increased awareness and safety measures when using these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden deaths in adult-worn baby carriers: 19 cases. Bergounioux, J., Madre, C., Crucis-Armengaud, A., et al.[2022]

The study compared the physiological responses of caregivers using traditional baby slings and modern front-worn harness carriers, involving 20 participants carrying baby dummies weighing 7 and 10 kg.

Results showed minimal differences in muscle activity and shoulder pressure between the two carrier types, but significant variations were noted based on the weight of the dummies, suggesting that carrier design could be improved for better comfort and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baby carriers: a comparison of traditional sling and front-worn, rear-facing harness carriers. Wu, CY., Huang, HR., Wang, MJ.[2017]

Despite campaigns to reduce sudden unexpected infant death, caregivers still place infants in unsafe sleeping environments like car seats and slings, which can lead to suffocation and breathing problems.

Healthcare providers must educate parents and caregivers about the dangers of using sitting devices for sleep and model safe practices to ensure infant safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Risks Sitting and Carrying Devices Pose to Safe Infant Sleep. Rholdon, R.[2017]

Caregivers of NICU graduates reported that using baby carriers for kangaroo care significantly reduced their stress and anxiety levels, promoting a sense of calm and improved attachment with their infants.

The study suggests that babywearing can serve as an effective intervention to support caregivers' mental health and well-being, potentially mitigating issues like depression and posttraumatic stress disorder after NICU discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is the Experience of Babywearing a NICU Graduate? Miller, RR., Bedwell, S., Laubach, LL., et al.[2022]

Women perceive postnatal care as having low value for healthy mothers and infants, which contributes to low uptake of these services, highlighting a significant gap in care.

There is a strong desire among women for more emotional and psychosocial support during the postnatal period, indicating that current care models may not adequately address the holistic needs of new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that influence uptake of routine postnatal care: Findings on women's perspectives from a qualitative evidence synthesis. Sacks, E., Finlayson, K., Brizuela, V., et al.[2023]

Low-income, urban, first-time mothers generally feel confident in their ability to care for themselves and their infants during the first six months postpartum, with few reported unmet learning needs.

External stressors such as financial issues and unstable living conditions significantly impact the health outcomes of these mothers, highlighting the need for healthcare providers to connect them with additional community resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-income, urban minority women's perceptions of self- and infant care during the postpartum period. Suplee, PD., Gardner, MR., Borucki, LC.[2016]

The first 6 weeks postpartum, often called the fourth trimester, are crucial for the health of both mothers and newborns, yet many new mothers miss important follow-up appointments that could prevent serious health issues.

To improve postpartum care during the COVID-19 pandemic, a mobile clinic was launched in Boston, providing comprehensive care with an average of 3 visits for each mother and newborn, addressing barriers to care and promoting better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Care Mobile Units: A Collaborative Midwifery and Pediatric Response to the COVID-19 Pandemic. McGuinness, C., Mottl-Santiago, J., Nass, M., et al.[2023]

Over half (50.8%) of the 1616 surveyed women rated their postnatal hospital care as 'very good', but many reported negative experiences related to caregiver interactions, such as midwives being perceived as rushed and not always sensitive.

The study highlights that communication and support regarding baby feeding and post-discharge advice significantly impact women's satisfaction with postnatal care, suggesting a need for improved caregiver training and staffing in postnatal wards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's views and experiences of postnatal hospital care in the Victorian Survey of Recent Mothers 2000. Brown, SJ., Davey, MA., Bruinsma, FJ.[2022]

References

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

Cardiorespiratory stability of premature and term infants carried in infant slings. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Sudden deaths in adult-worn baby carriers: 19 cases. [2022]

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

Baby carriers: a comparison of traditional sling and front-worn, rear-facing harness carriers. [2017]

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

Understanding the Risks Sitting and Carrying Devices Pose to Safe Infant Sleep. [2017]

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

What Is the Experience of Babywearing a NICU Graduate? [2022]

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

Factors that influence uptake of routine postnatal care: Findings on women's perspectives from a qualitative evidence synthesis. [2023]

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

Low-income, urban minority women's perceptions of self- and infant care during the postpartum period. [2016]

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

Dyadic Care Mobile Units: A Collaborative Midwifery and Pediatric Response to the COVID-19 Pandemic. [2023]

9. Scotland pubmed.ncbi.nlm.nih.gov

Women's views and experiences of postnatal hospital care in the Victorian Survey of Recent Mothers 2000. [2022]