Couplet Care Bassinet for Mother and Infant Outcomes

Overseen By Monica Brown, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Multiple infants, Infant not rooming-in

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 days

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Couplet Care bassinet improves outcomes for mothers and their babies in the hospital after birth compared to the standard bassinet. The main focus is on how the new bassinet affects the mother's sleep, breastfeeding, and overall satisfaction. Eligible participants must be postpartum, at least 18 years old, able to communicate in English, and have a single baby who stays with them in the hospital room. Participants will be surveyed about their experiences, and hospital staff will provide feedback. The trial will compare the experiences of those using the new bassinet to those using the traditional one. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance postpartum care for future mothers and babies.

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 prior data suggests that the Couplet Care bassinet is safe for maternal-infant use?

Research shows that the Couplet Care bassinet is safe and easy to use for both mothers and their babies. This new bassinet adjusts to fit over the mother's bed, making it easier for her to reach her baby. Its design supports breastfeeding and skin-to-skin contact, which are important for bonding and the baby's health.

Studies have examined how the bassinet can improve safety. It keeps the baby secure, reducing the risk of falls or other accidents. The bassinet also allows mothers to keep their babies close, which can lessen the need for help from hospital staff and increase satisfaction for new parents.

While specific data on negative events with this bassinet is unavailable, its focus on safety is clear. Since the trial is in a "Not Applicable" phase, it doesn't involve a drug or invasive procedure, so the safety risks are minimal compared to other medical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Couplet Care Bassinet is unique because it offers features designed to enhance the mother-infant bonding experience immediately after birth. Unlike standard hospital bassinets, which are often separate and less accessible, the Couplet Care Bassinet can be positioned over the mother's bed, allowing for easier access to the baby. This bassinet also securely anchors the infant tub and includes access points in its walls, potentially making it safer and more convenient. Researchers are excited about this trial because they hope to find out if these innovations improve outcomes for both mothers and their newborns by fostering closer interactions and reducing physical strain.

What evidence suggests that the Couplet Care bassinet is effective for improving maternal-infant outcomes?

This trial will compare the Couplet Care bassinet with the standard bassinet. Research has shown that the Couplet Care bassinet might improve health outcomes for mothers and newborns. Its design allows mothers easier access to their babies, enhancing breastfeeding and skin-to-skin contact. These activities are known to lead to healthier results for both mothers and babies. Additionally, the bassinet aims to make the postpartum period safer and more convenient, potentially aiding in better maternal recovery. While further studies could confirm these benefits, early signs are promising for the well-being of both mothers and infants. ^{2 6 7 8 9}

Who Is on the Research Team?

Cecilia Tomori, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for new mothers and their infants in the postnatal hospital setting. Participants should be willing to provide feedback on their sleep, breastfeeding experience, and overall satisfaction with the bassinet they're assigned.

Inclusion Criteria

Who can communicate in English

I have recently given birth.

Exclusion Criteria

Postpartum female with multiple infants (twins or more)

Participant with an infant who is not rooming-in, such as for infant or maternal intensive care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assigned either the standard bassinet or the Couplet Care bassinet and are monitored for maternal-infant outcomes

Up to 3 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and chart reviews

1 year

Surveys and assessments

What Are the Treatments Tested in This Trial?

Interventions

• Couplet Care Bassinet

Trial Overview

The study compares two types of bassinets: the Couplet Care Bassinet designed for closer mother-infant interaction, and a standard bassinet. It aims to determine which one leads to better outcomes like sleep quality, breastfeeding success, and patient satisfaction.

How Is the Trial Designed?

Group I: Couplet Care Bassinet Experimental Treatment 1 Intervention

125 mother-infant pairs will be assigned the Couplet Care bassinet. This bassinet has adjustability features to allow for bassinet positioning over the mother to enable access to the baby, secures the tub in the frame, and has a wall with access points.

Group II: Standard Bassinet Active Control 1 Intervention

125 mother-infant pairs will be assigned the current hospital bassinet offered at the research site. The current bassinet is an unanchored acrylic tub with high walls on a wheeled cart with some storage.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Couplet Care LLC

Collaborator

Trials

1

Recruited

500+

Published Research Related to This Trial

Mothers of twins and higher order multiples (triplets and beyond) are significantly more likely to choose bottle-feeding compared to mothers of singletons, and they tend to breast-feed for shorter durations when they do breast-feed.

Factors influencing the decision to bottle-feed include lack of husband cooperation in childrearing and higher levels of anxiety regarding the multiple pregnancy, with mothers experiencing these issues being 1.83 and 1.73 times more likely to choose bottle-feeding, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast-feeding and bottle-feeding of twins, triplets and higher order multiple births. Yokoyama, Y., Ooki, S.[2011]

Both mothers of late preterm (LPT) twins and term twins initiated breastfeeding at high rates (100% and 96%, respectively), but by 4 months, significantly fewer mothers of LPT twins continued breastfeeding (44% vs. 75% for term twins).

Mothers of LPT twins faced unique challenges, such as their infants' immature breastfeeding behaviors and a lack of support from healthcare professionals, which led to questioning the value of their efforts and ultimately contributed to a higher cessation rate of breastfeeding compared to mothers of term twins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding initiation, duration, and experiences of mothers of late preterm twins: a mixed-methods study. Jonsdottir, RB., Flacking, R., Jonsdottir, H.[2022]

Preterm twins can establish and maintain breastfeeding as successfully as preterm singleton infants, with 89% of twins and 93% of singletons breastfeeding at discharge from the hospital.

The breastfeeding rates declined similarly for both groups, with 68% breastfeeding at 8-12 weeks and 49% at 12-16 weeks after birth, indicating that with proper support, preterm infants can achieve breastfeeding rates comparable to term infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can preterm twins breast feed successfully? Liang, R., Gunn, AJ., Gunn, TR.[2004]

Breastfeeding has significant health and developmental benefits for both pre-term and full-term infants, which has led to a shift in how nutrition is approached for twins and higher-order multiples.

Mothers of twins face challenges in starting breastfeeding while in the hospital, highlighting the need for targeted interventions and support to help them successfully initiate lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Breast feeding of twins with regard to pre-term infants]. Mikiel-Kostyra, K.[2017]

Mothers of very preterm twins experience higher levels of parenting stress and show lower responsiveness in interactions compared to mothers of singletons, indicating a greater challenge in caregiving.

Twin infants demonstrate poorer communication skills, as evidenced by lower interaction scores at both hospital discharge and three months corrected age, which may contribute to the increased stress experienced by their mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twin birth: an additional risk factor for poorer quality maternal interactions with very preterm infants? Beer, C., Israel, C., Johnson, S., et al.[2013]

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Building a better bassinet

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pmc.ncbi.nlm.nih.gov/articles/PMC11647370/

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Couplet Care Bassinet for Mother and Infant Outcomes

The goal of this study is to evaluate the impact of the Couplet Care bassinet on maternal-infant outcomes in the postnatal hospital setting.The main question ...

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grepbeat.com

grepbeat.com/2021/04/15/couplet-care-addresses-health-equity-by-designing-bassinet-for-new-mothers/

Couplet Care Addresses Health Equity By Designing ...

The Couplet Care bassinet design itself provides safer and more convenient access for mother to baby. It has labels in English and Spanish and relies on ...

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prweb.com

prweb.com/releases/the-couplet-care-bassinet-is-now-available-in-the-united-states-redefining-postpartum-care-for-moms-and-babies-302272548.html

The Couplet Care Bassinet™ is now available in ...

The Couplet Care Bassinet is designed to improve childbirth recovery for birthing parents while ensuring newborn safety and connection.

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reporter.nih.gov

reporter.nih.gov/search/15EEC10D4C8DC5D37598B8961CAA4A01A2FFCEB861BF/project-details/10907832

Development of the Couplet Care Bassinet to support safe ...

To address these gaps in safe care, Couplet Care has developed a novel bassinet that allows mothers to position infants over their bed and handle the infants ...

7.

coupletcare.com

coupletcare.com/

Couplet System of Care | Innovative Bassinet Connecting ...

The bassinet facilitates breastfeeding, skin-to-skin contact, safe sleep, patient safety, and clinical efficiency in the precious early days after childbirth.

8.

patientsafety.pa.gov

patientsafety.pa.gov/ADVISORIES/Pages/201409_102.aspx

Balancing Family Bonding with Newborn Safety Advisory

More than 9% of the events contributed to serious patient harm. Literature shows that healthcare facilities can make a difference in newborn events by ...

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ctv.veeva.com

ctv.veeva.com/study/development-of-the-couplet-care-bassinet

Development of the Couplet Care Bassinet

The goal of this study is to evaluate the impact of the Couplet Care bassinet on maternal-infant outcomes in the postnatal hospital setting.