Development of the Couplet Care Bassinet
NCT Number: NCT06533449
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breastfeeding|Sleep|Patient Satisfaction
Interventions: DEVICE: Couplet Care Bassinet|DEVICE: Standard Bassinet
Sponsor: Johns Hopkins University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|Couplet Care LLC
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-09
Completion Date: 2025-07-30
Locations: Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States

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.

Primary Outcome Measures: Maternal reported infant wakings, Number of times mothers report infant waking, Up to 3 days (until discharge)
Secondary Outcome Measures: 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: 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