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Behavioural Intervention

Couplet Care Bassinet for Sleep

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
Inclusion Criteria: (from protocol)
* postpartum female participant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

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

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
2,001 Previous Clinical Trials
2,687,714 Total Patients Enrolled
8 Trials studying Sleep
1,517 Patients Enrolled for Sleep
Johns Hopkins UniversityLead Sponsor
2,295 Previous Clinical Trials
14,852,887 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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