Development of the Couplet Care Bassinet

Development of the Couplet Care Bassinet to Support Safe Implementation of Skin-to-skin Contact and rooming-in on Postnatal Units

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Patient Satisfaction; Breastfeeding
• Intervention / Treatment: Device: Couplet Care Bassinet; Device: Standard 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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilia Tomori, PhD; Phone Number: 2404416153; Email: ctomori1@jh.edu
• Study Contact Backup: Name: Monica Brown, MS; Phone Number: 667-306-9823; Email: mbrow374@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Cecilia Tomori, PhD; Email: ctomori1@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Couplet Care Bassinet; Couplet Care Bassinet
Active Comparator: 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.	Device: Standard Bassinet; Standard Bassinet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal reported infant wakings	Number of times mothers report infant waking	Up to 3 days (until discharge)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician usability assessment	Clinician usability assessment table; clinician must rate 13 statements regarding usability of the bassinet on a scale of 1 to 5 in which 1 is "strongly disagree" and 5 is "strongly agree." Score range 13-65; higher score higher usability	1 year
Administrator adoptability assessment	Adoptability table in which administrators rate 4 statements regarding adoptability of the bassinet on a scale of 1 to 5 with 1 being "strongly disagree" and 5 being "strongly agree." Score range 4-20,higher score higher adoptability.	1 year
Satisfaction with Bassinet Design	Participants, clinicians, and administrators will be provided open ended questionnaires regarding the design of the bassinet and satisfaction with bassinet use. The participants will be asked two questions to rate the bassinet on ease of use and design on a scale of 1 to 10 with 1 being "not at all" and 10 being "very much". Score range 2-20.	1 year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Couplet Care LLC
• Investigators: Principal Investigator: Cecilia Tomori, PhD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Tully KP, Ball HL. Postnatal unit bassinet types when rooming-in after cesarean birth: implications for breastfeeding and infant safety. J Hum Lact. 2012 Nov;28(4):495-505. doi: 10.1177/0890334412452932. Epub 2012 Aug 22.
• Taylor, Catherine & Tully, Kristin & Ball, Helen. (2015). Night-time on a postnatal ward: experiences of mothers, infants, and staff.
• 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.
• 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.
• Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry 1996;189(194):4-7
• 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.
• 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.

Helpful Links

• WHO/UNICEF Statement

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: sleep; breastfeeding; Cesarean Section; bassinet; skin-to-skin; rooming-in
• Other Study ID Numbers: IRB00316391; R44HD097017 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No