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Behavioural Intervention

Couplet Care Bassinet for Mother and Infant Outcomes

N/A
Waitlist Available
Led By Cecilia Tomori, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postpartum female participant
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

"This trial aims to see if using the Couplet Care bassinet in hospitals leads to better outcomes for mothers and infants compared to the standard bassinet. Mothers will be asked about their experiences with the bass

Who is the study for?
This trial is for new mothers and their infants in the postnatal hospital setting. Participants should be willing to provide feedback on their sleep, breastfeeding experience, and overall satisfaction with the bassinet they're assigned.
What is being tested?
The study compares two types of bassinets: the Couplet Care Bassinet designed for closer mother-infant interaction, and a standard bassinet. It aims to determine which one leads to better outcomes like sleep quality, breastfeeding success, and patient satisfaction.
What are the potential side effects?
Since this trial involves non-medical equipment (bassinets), there are no direct medical side effects. However, participants may experience differences in comfort or convenience that could affect their rest or interactions with their infant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have recently given birth.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maternal reported infant wakings
Secondary study objectives
Breastfeeding duration (minutes)
Breastfeeding frequency
Infant feeding substance
+4 more
Other study objectives
Administrator adoptability assessment
Clinician usability assessment
Satisfaction with Bassinet Design

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Couplet Care BassinetExperimental Treatment1 Intervention
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 II: Standard BassinetActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,334 Total Patients Enrolled
8 Trials studying Sleep
1,517 Patients Enrolled for Sleep
Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,409 Total Patients Enrolled
7 Trials studying Sleep
4,154 Patients Enrolled for Sleep
Couplet Care LLCUNKNOWN
~333 spots leftby Jul 2025
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