Development of the Couplet Care Bassinet

NCT ID: NCT06533449

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2026-07-31

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.

Conditions

Breastfeeding; Sleep; Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Couplet Care Bassinet

Intervention Type: DEVICE

Couplet Care 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.

Group Type: ACTIVE_COMPARATOR

Standard Bassinet

Intervention Type: DEVICE

Standard Bassinet

Interventions

Couplet Care Bassinet

Couplet Care Bassinet

Intervention Type: DEVICE

Standard Bassinet

Standard Bassinet

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Couplet Care LLC

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia Tomori, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cecilia Tomori, PhD

Role: CONTACT

ctomori1@jh.edu

2404416153

Monica Brown, MS

Role: CONTACT

mbrow374@jh.edu

667-306-9823

Facility Contacts

Cecilia Tomori, PhD

Role: primary

ctomori1@jh.edu

References

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Reference Type: BACKGROUND

PMID: 22914755 (View on PubMed)

Tully KP, Ball HL. Maternal accounts of their breast-feeding intent and early challenges after caesarean childbirth. Midwifery. 2014 Jun;30(6):712-9. doi: 10.1016/j.midw.2013.10.014. Epub 2013 Oct 26.

Reference Type: BACKGROUND

PMID: 24252711 (View on PubMed)

Taylor, Catherine & Tully, Kristin & Ball, Helen. (2015). Night-time on a postnatal ward: experiences of mothers, infants, and staff.

Reference Type: BACKGROUND

Seashore C, Tully KP. Preventing Newborn Falls and Improving Care for Postpartum Women and Their Newborns. Hosp Pediatr. 2018 Sep;8(9):593-594. doi: 10.1542/hpeds.2018-0121. Epub 2018 Aug 1. No abstract available.

Reference Type: BACKGROUND

PMID: 30068525 (View on PubMed)

Grant D. The "Quiet Revolution" and the cesarean section in the United States. Econ Hum Biol. 2022 Dec;47:101192. doi: 10.1016/j.ehb.2022.101192. Epub 2022 Oct 17.

Reference Type: BACKGROUND

PMID: 36351359 (View on PubMed)

Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry 1996;189(194):4-7

Reference Type: BACKGROUND

Crenshaw JT. Healthy Birth Practice #6: Keep Mother and Baby Together- It's Best for Mother, Baby, and Breastfeeding. J Perinat Educ. 2014 Fall;23(4):211-7. doi: 10.1891/1058-1243.23.4.211.

Reference Type: BACKGROUND

PMID: 25411542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32154198 (View on PubMed)

Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.

Reference Type: BACKGROUND

PMID: 27885658 (View on PubMed)

McKeever J, Fleur RS. Overcoming barriers to Baby-Friendly status: one hospital's experience. J Hum Lact. 2012 Aug;28(3):312-4. doi: 10.1177/0890334412440627. Epub 2012 May 17.

Reference Type: BACKGROUND

PMID: 22596059 (View on PubMed)

Related Links

https://iris.who.int/bitstream/handle/10665/39679/9241561300.pdf?sequence=1&isAllowed=y

WHO/UNICEF Statement

Other Identifiers

R44HD097017

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00316391

Identifier Type: -

Identifier Source: org_study_id