Development of the Couplet Care Bassinet

Not Applicable

Not yet recruiting

• Conditions: Sleep; Patient Satisfaction; Breastfeeding
• Interventions: Device: Couplet Care Bassinet; Device: Standard Bassinet

• Registration Number: NCT06533449
• Lead Sponsor: Johns Hopkins University

Brief Summary

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 this study aims to answer is: Does the Couplet Care bassinet have better maternal-infant outcomes compared to the standard bassinet?

The mother participants will:

-be surveyed about experiences with and use of the bassinet including: the mother's sleep, breastfeeding, calls to staff, infant location, and satisfaction.

Charts will be reviewed for additional outcomes.

Hospital staff and administrators will be surveyed about experiences with the bassinet.

Detailed Description

The current study is a Phase II evaluation of the Couplet Care bassinet, designed by Couplet Care Limited Liability Corporation (LLC), a novel infant clinical bassinet designed to support safe implementation of skin-to-skin contact and rooming-in on postnatal units. Until recently, the standard of hospital care for healthy term newborns was to be observed and cared for by maternity staff in a nursery with other infants. However, as detailed in the World Health Organization (WHO) / United Nations International Children's Emergency Fund (UNICEF) report Ten Steps for Successful Breastfeeding, it is now recommended that mothers and infants "room-in" together 24 hours per day, with one hour of separation allowable for procedures outside of the postnatal unit room. As a result, the practice of nursery care is no longer recommended nor facilitated. However, most bassinets in United States (U.S.) hospitals are still designed for use by ambulatory nursery staff, rather than by mobility-impaired new mothers. Current bassinets were not designed for patient use and restrict maternal access to the infants and introduce infants to increased risk of physical injury. Bassinet tubs can tip under the weight of mothers' arms and the height of the tub walls can compromise infant handling. Often, new mothers are required to either substantially twist the body to access the infant or get up out of bed to reach the infant, despite being in immediate postpartum period and needing to heal. Such actions can cause new mothers to experience unnecessary frustration, pain, or even injury. This is especially critical to the one-third of U.S. women who deliver by cesarean section, as the mother's limited ability to move and postpartum pain hinder timely and safe infant care, undermine breastfeeding, impede the mother's own recovery, and contribute to risk of infant falls and suffocation. The substantial difficulty maneuvering infants in and out of conventional bassinets, coupled with the pain and fatigue felt by new mothers, increase the risk of 1) infant drops, and 2) falling asleep with infants in unsafe arrangements. To address these gaps in safety Couplet Care has developed a novel bassinet that allows mothers to position infants over the mother's bed and handle the infants independently.

To ensure usability and safety, the Couplet Care bassinet design incorporates (1) a lower tub wall with access points, making it easier for a mother to reach her infant, (2) adjustability features that allow for bassinet positioning over the mother, and (3) a design that secures the tub into the frame.

In this phase of the project, the researchers will build on insights of Phase I to refine Couplet Care bassinet design, so it is manufacturable and compliant with Food and Drug Administration (FDA) regulations. Next, the Study Team component of the study will:

1. Evaluate the impact of the Couplet Care bassinet on maternal-infant patient outcomes in a powered randomized controlled trial (RCT)

2. Evaluate the usability and adoptability of the device from clinician perspectives. Successful accomplishment of this Phase II effort will position the Couplet Care bassinet for commercialization, delivering a bassinet that promotes safe mother-infant connection during rooming-in, while reducing the risk of infant drops/falls and suffocation, maternal waking from unmet infant needs, and demands on nurses for assistance for non-medical needs.

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Study Start: 2025-01-06
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

(from protocol)

• postpartum female participant
• at least 18 years of age
• who can communicate in English

Read More

Exclusion Criteria

• If postpartum female has had multiple infants (twins or more) or
• participant has an infant who is not rooming-in, such as for infant or maternal intensive care

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Couplet Care Bassinet	Couplet Care Bassinet	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.
Standard Bassinet	Standard Bassinet	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.

Primary Outcome Measures

Name	Time	Method
Maternal reported infant wakings	Up to 3 days (until discharge)	Number of times mothers report infant waking

Secondary Outcome Measures

Name	Time	Method
Number of minutes infants were outside of the post-natal unit	Up to 3 days (until discharge)	Number of minutes infants were outside of the post-natal unit (rooming-in)
Breastfeeding duration (minutes)	Up to 3 days (until discharge)	Breastfeeding duration
Number of calls to clinical staff	Up to 3 days (until discharge)	number of calls by study participants to clinical staff
Length of postpartum hospitalization	Up to 3 days (until discharge)	Length of hospitalization
Infant feeding substance	Up to 3 days (until discharge)	Type of feeding substance (participant's own milk, donor human milk, formula use, combination)
Post-Partum pain levels	Up to 3 days (until discharge)	reported pain level from participants to medical staff on a scale of 1-10. Higher score indicates higher pain.
Breastfeeding frequency	Up to 3 days (until discharge)	Breastfeeding frequency

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States