Evaluating a new bassinet for better maternal-infant outcomes
Development of the Couplet Care Bassinet to Support Safe Implementation of Skin-to-skin Contact and rooming-in on Postnatal Units
This study tests a new bassinet that aims to improve the connection between mothers and their babies after birth to see if it helps with sleep, breastfeeding, and overall satisfaction compared to regular bassinets.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06533449 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Couplet Care bassinet, designed to enhance maternal-infant interactions in postnatal care. It compares the outcomes of mothers and infants using this innovative bassinet against those using standard bassinets. Participants will provide feedback on their experiences, including sleep quality, breastfeeding success, and overall satisfaction. Additionally, hospital staff will be surveyed to assess their experiences with the new bassinet. The goal is to determine if this new design improves maternal-infant bonding and care.
Who should consider this trial
Good fit: Ideal candidates are postpartum females aged 18 and older who can communicate in English.
Not a fit: Patients with multiple infants or those whose infants are not rooming-in will not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved breastfeeding rates and maternal satisfaction in postnatal care.
How similar studies have performed: Other studies have shown positive outcomes with similar approaches to maternal-infant care, but this specific intervention is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (from protocol) * postpartum female participant * at least 18 years of age * who can communicate in English Exclusion Criteria: * 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Cecilia Tomori, PhD — Johns Hopkins University
- Study coordinator: Cecilia Tomori, PhD
- Email: ctomori1@jh.edu
- Phone: 2404416153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.