Status:
RECRUITING
Development of the Couplet Care Bassinet
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Couplet Care LLC
Conditions:
Breastfeeding
Sleep
Eligibility:
FEMALE
18+ years
Phase:
NA
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 C...
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 impleme...
Eligibility Criteria
Inclusion
- (from protocol)
- postpartum female participant
- at least 18 years of age
- who can communicate in English
Exclusion
- 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
Key Trial Info
Start Date :
January 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06533449
Start Date
January 9 2025
End Date
July 31 2026
Last Update
August 5 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287