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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met