Clinical trial NCT06533449: Development of the Couplet Care Bassinet
Official title: Development of the Couplet Care Bassinet to Support Safe Implementation of Skin-to-skin Contact and rooming-in on Postnatal Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Sleep
Patient Satisfaction
Keywords: skin-to-skin
rooming-in
breastfeeding
sleep
bassinet
Cesarean Section
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Couplet Care LLC
First posted: 2024-08-01
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will enroll 250 mother-infant pairs at the research location (total n=500, 250 mothers and the infants (250). Half of the pairs (n=250; 125 mothers, 125 infants) will be allocated the Couplet Care Bassinet from enrollment on the postnatal unit through discharge. The other half (n=250; 125 mothers, 125 infants) will be enrolled and assessed as controls with the standard bassinet used at the research site
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria: (from protocol)

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

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

Primary outcomes:
measure: Maternal reported infant wakings
timeFrame: Up to 3 days (until discharge)
Secondary outcomes:
measure: Post-Partum pain levels
timeFrame: Up to 3 days (until discharge)
measure: Infant feeding substance
timeFrame: Up to 3 days (until discharge)
measure: Length of postpartum hospitalization
timeFrame: Up to 3 days (until discharge)
measure: Number of minutes infants were outside of the post-natal unit
timeFrame: Up to 3 days (until discharge)
measure: Breastfeeding frequency
timeFrame: Up to 3 days (until discharge)
measure: Breastfeeding duration (minutes)
timeFrame: Up to 3 days (until discharge)
measure: Number of calls to clinical staff
timeFrame: Up to 3 days (until discharge)
Other outcomes:
measure: Clinician usability assessment
timeFrame: 1 year
measure: Administrator adoptability assessment
timeFrame: 1 year
measure: Satisfaction with Bassinet Design
timeFrame: 1 year
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cecilia Tomori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Consales A, Crippa BL, Cerasani J, Morniroli D, Damonte M, Bettinelli ME, Consonni D, Colombo L, Zanotta L, Bezze E, Sannino P, Mosca F, Plevani L, Gianni ML. Overcoming Rooming-In Barriers: A Survey on Mothers' Perspectives. Front Pediatr. 2020 Feb 21;8:53. doi: 10.3389/fped.2020.00053. eCollection 2020.
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