BreastfeedingNCT06533449
Development of the Couplet Care Bassinet
A study testing Couplet Care Bassinet and Standard Bassinet in people with Breastfeeding and Sleep, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Sleep, Patient Satisfaction
- What is being tested?
- Couplet Care Bassinet and Standard Bassinet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postpartum female participant
- at least 18 years of age
- who can communicate in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of the Couplet Care Bassinet to Support Safe Implementation of Skin-to-skin Contact and rooming-in on Postnatal Units
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.
Read the 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 implementation of skin-to-skin contact and rooming-in on postnatal units. Until recently, the standard of hospital care for healthy term newborns was to be observed and cared for by maternity staff in a nursery with other infants. However, as detailed in the World Health Organization (WHO) / United Nations International Children's Emergency Fund (UNICEF) report Ten Steps for Successful Breastfeeding, it is now recommended that mothers and infants "room-in" together 24 hours per day, with one hour of separation allowable for procedures outside of the postnatal unit room. As a result, the practice of nursery care is no longer recommended nor facilitated. However, most bassinets in United States (U.S.) hospitals are still designed for use by ambulatory nursery staff, rather than by mobility-impaired new mothers. Current bassinets were not designed for patient use and restrict maternal access to the infants and introduce infants to increased risk of physical injury. Bassinet tubs can tip under the weight of mothers' arms and the height of the tub walls can compromise infant handling. Often, new mothers are required to either substantially twist the body to access the infant or get up out of bed to reach the infant, despite being in immediate postpartum period and needing to heal. Such actions can cause new mothers to experience unnecessary frustration, pain, or even injury. This is especially critical to the one-third of U.S. women who deliver by cesarean section, as the mother's limited ability to move and postpartum pain hinder timely and safe infant care, undermine breastfeeding, impede the mother's own recovery, and contribute to risk of infant falls and suffocation. The substantial difficulty maneuvering infants in and out of conventional bassinets, coupled with the pain and fatigue felt by new mothers, increase the risk of 1) infant drops, and 2) falling asleep with infants in unsafe arrangements. To address these gaps in safety Couplet Care has developed a novel bassinet that allows mothers to position infants over the mother's bed and handle the infants independently.
To ensure usability and safety, the Couplet Care bassinet design incorporates (1) a lower tub wall with access points, making it easier for a mother to reach her infant, (2) adjustability features that allow for bassinet positioning over the mother, and (3) a design that secures the tub into the frame.
In this phase of the project, the researchers will build on insights of Phase I to refine Couplet Care bassinet design, so it is manufacturable and compliant with Food and Drug Administration (FDA) regulations. Next, the Study Team component of the study will:
- Evaluate the impact of the Couplet Care bassinet on maternal-infant patient outcomes in a powered randomized controlled trial (RCT)
- Evaluate the usability and adoptability of the device from clinician perspectives. Successful accomplishment of this Phase II effort will position the Couplet Care bassinet for commercialization, delivering a bassinet that promotes safe mother-infant connection during rooming-in, while reducing the risk of infant drops/falls and suffocation, maternal waking from unmet infant needs, and demands on nurses for assistance for non-medical needs.
- Conditions
- Breastfeeding, Sleep, Patient Satisfaction
- Being tested
- Couplet Care Bassinet, Standard Bassinet
- Keywords
- skin-to-skin, rooming-in, breastfeeding, sleep, bassinet, Cesarean Section
- Medical subject headings
- Breast Feeding, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couplet Care BassinetDevice
Couplet Care Bassinet
Standard BassinetDevice
Standard Bassinet
| Study group | Role | What they receive |
|---|---|---|
| Couplet Care Bassinet | Experimental | 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. Receives: Device: Couplet Care Bassinet |
| Standard Bassinet | Active comparator | 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. Receives: Device: Standard Bassinet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal reported infant wakings
Number of times mothers report infant waking
Measured: Up to 3 days (until discharge)
Secondary outcomes (7)
Post-Partum pain levels
reported pain level from participants to medical staff on a scale of 1-10. Higher score indicates higher pain.
Measured: Up to 3 days (until discharge)
Infant feeding substance
Type of feeding substance (participant's own milk, donor human milk, formula use, combination)
Measured: Up to 3 days (until discharge)
Length of postpartum hospitalization
Length of hospitalization
Measured: Up to 3 days (until discharge)
Number of minutes infants were outside of the post-natal unit
Number of minutes infants were outside of the post-natal unit (rooming-in)
Measured: Up to 3 days (until discharge)
Breastfeeding frequency
Breastfeeding frequency
Measured: Up to 3 days (until discharge)
Breastfeeding duration (minutes)
Breastfeeding duration
Measured: Up to 3 days (until discharge)
Number of calls to clinical staff
number of calls by study participants to clinical staff
Measured: Up to 3 days (until discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start9 Jan 2025
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll 250 mother-infant pairs at the research location (total n=500, 250 mothers and the infants (250). Half of the pairs (n=250; 125 mothers, 125 infants) will be allocated the Couplet Care Bassinet from enrollment on the postnatal unit through discharge. The other half (n=250; 125 mothers, 125 infants) will be enrolled and assessed as controls with the standard bassinet used at the research site
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Couplet Care LLC
- Responsible party
- Sponsor
- Investigators
- Cecilia Tomori, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533449
- Sponsor's protocol ID
- IRB00316391
- Other IDs
- R44HD097017
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tully KP, Ball HL. Postnatal unit bassinet types when rooming-in after cesarean birth: implications for breastfeeding and infant safety. J Hum Lact. 2012 Nov;28(4):495-505. doi: 10.1177/0890334412452932. Epub 2012 Aug 22.
PubMed 22914755Tully KP, Ball HL. Maternal accounts of their breast-feeding intent and early challenges after caesarean childbirth. Midwifery. 2014 Jun;30(6):712-9. doi: 10.1016/j.midw.2013.10.014. Epub 2013 Oct 26.
PubMed 24252711Taylor, Catherine & Tully, Kristin & Ball, Helen. (2015). Night-time on a postnatal ward: experiences of mothers, infants, and staff.
Seashore C, Tully KP. Preventing Newborn Falls and Improving Care for Postpartum Women and Their Newborns. Hosp Pediatr. 2018 Sep;8(9):593-594. doi: 10.1542/hpeds.2018-0121. Epub 2018 Aug 1. No abstract available.
PubMed 30068525Grant D. The "Quiet Revolution" and the cesarean section in the United States. Econ Hum Biol. 2022 Dec;47:101192. doi: 10.1016/j.ehb.2022.101192. Epub 2022 Oct 17.
PubMed 36351359Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry 1996;189(194):4-7
Crenshaw JT. Healthy Birth Practice #6: Keep Mother and Baby Together- It's Best for Mother, Baby, and Breastfeeding. J Perinat Educ. 2014 Fall;23(4):211-7. doi: 10.1891/1058-1243.23.4.211.
PubMed 25411542Consales A, Crippa BL, Cerasani J, Morniroli D, Damonte M, Bettinelli ME, Consonni D, Colombo L, Zanotta L, Bezze E, Sannino P, Mosca F, Plevani L, Gianni ML. Overcoming Rooming-In Barriers: A Survey on Mothers' Perspectives. Front Pediatr. 2020 Feb 21;8:53. doi: 10.3389/fped.2020.00053. eCollection 2020.
PubMed 32154198Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.
PubMed 27885658McKeever J, Fleur RS. Overcoming barriers to Baby-Friendly status: one hospital's experience. J Hum Lact. 2012 Aug;28(3):312-4. doi: 10.1177/0890334412440627. Epub 2012 May 17.
PubMed 22596059
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Couplet Care Bassinet to Support Safe Implementation of Skin-to-skin Contact and rooming-in on Postnatal Units
- ClinicalTrials.gov ID
- NCT06533449
- Acronym / sponsor ID
- IRB00316391
- Conditions
- Breastfeeding, Sleep, Patient Satisfaction
- Keywords
- skin-to-skin, rooming-in, breastfeeding, sleep, bassinet, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Couplet Care LLC
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 implementation of skin-to-skin contact and rooming-in on postnatal units. Until recently, the standard of hospital care for healthy term newborns was to be observed and cared for by maternity staff in a nursery with other infants. However, as detailed in the World Health Organization (WHO) / United Nations International Children's Emergency Fund (UNICEF) report Ten Steps for Successful Breastfeeding, it is now recommended that mothers and infants "room-in" together 24 hours per day, with one hour of separation allowable for procedures outside of the postnatal unit room. As a result, the practice of nursery care is no longer recommended nor facilitated. However, most bassinets in United States (U.S.) hospitals are still designed for use by ambulatory nursery staff, rather than by mobility-impaired new mothers. Current bassinets were not designed for patient use and restrict maternal access to the infants and introduce infants to increased risk of physical injury. Bassinet tubs can tip under the weight of mothers' arms and the height of the tub walls can compromise infant handling. Often, new mothers are required to either substantially twist the body to access the infant or get up out of bed to reach the infant, despite being in immediate postpartum period and needing to heal. Such actions can cause new mothers to experience unnecessary frustration, pain, or even injury. This is especially critical to the one-third of U.S. women who deliver by cesarean section, as the mother's limited ability to move and postpartum pain hinder timely and safe infant care, undermine breastfeeding, impede the mother's own recovery, and contribute to risk of infant falls and suffocation. The substantial difficulty maneuvering infants in and out of conventional bassinets, coupled with the pain and fatigue felt by new mothers, increase the risk of 1) infant drops, and 2) falling asleep with infants in unsafe arrangements. To address these gaps in safety Couplet Care has developed a novel bassinet that allows mothers to position infants over the mother's bed and handle the infants independently.
To ensure usability and safety, the Couplet Care bassinet design incorporates (1) a lower tub wall with access points, making it easier for a mother to reach her infant, (2) adjustability features that allow for bassinet positioning over the mother, and (3) a design that secures the tub into the frame.
In this phase of the project, the researchers will build on insights of Phase I to refine Couplet Care bassinet design, so it is manufacturable and compliant with Food and Drug Administration (FDA) regulations. Next, the Study Team component of the study will:
- Evaluate the impact of the Couplet Care bassinet on maternal-infant patient outcomes in a powered randomized controlled trial (RCT)
- Evaluate the usability and adoptability of the device from clinician perspectives. Successful accomplishment of this Phase II effort will position the Couplet Care bassinet for commercialization, delivering a bassinet that promotes safe mother-infant connection during rooming-in, while reducing the risk of infant drops/falls and suffocation, maternal waking from unmet infant needs, and demands on nurses for assistance for non-medical needs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will enroll 250 mother-infant pairs at the research location (total n=500, 250 mothers and the infants (250). Half of the pairs (n=250; 125 mothers, 125 infants) will be allocated the Couplet Care Bassinet from enrollment on the postnatal unit through discharge. The other half (n=250; 125 mothers, 125 infants) will be enrolled and assessed as controls with the standard bassinet used at the research site
| Arm | Type | Receives |
|---|---|---|
| Couplet Care Bassinet | Experimental | Device: Couplet Care Bassinet125 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. |
| Standard Bassinet | Active comparator | Device: Standard Bassinet125 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- postpartum female participant
- at least 18 years of age
- who can communicate in English
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couplet Care BassinetCouplet Care Bassinet | Device | Couplet Care Bassinet |
| Standard BassinetStandard Bassinet | Device | Standard Bassinet |
Primary outcome
Maternal reported infant wakings
Time frame: Up to 3 days (until discharge)
Number of times mothers report infant waking
7 secondary outcomes
Post-Partum pain levels
Time frame: Up to 3 days (until discharge)
Infant feeding substance
Time frame: Up to 3 days (until discharge)
Length of postpartum hospitalization
Time frame: Up to 3 days (until discharge)
Number of minutes infants were outside of the post-natal unit
Time frame: Up to 3 days (until discharge)
Breastfeeding frequency
Time frame: Up to 3 days (until discharge)
Breastfeeding duration (minutes)
Time frame: Up to 3 days (until discharge)
Number of calls to clinical staff
Time frame: Up to 3 days (until discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 22914755Tully KP, Ball HL. Postnatal unit bassinet types when rooming-in after cesarean birth: implications for breastfeeding and infant safety. J Hum Lact. 2012 Nov;28(4):495-505. doi: 10.1177/0890334412452932. Epub 2012 Aug 22.
- Background: PubMed 24252711Tully KP, Ball HL. Maternal accounts of their breast-feeding intent and early challenges after caesarean childbirth. Midwifery. 2014 Jun;30(6):712-9. doi: 10.1016/j.midw.2013.10.014. Epub 2013 Oct 26.
- BackgroundTaylor, Catherine & Tully, Kristin & Ball, Helen. (2015). Night-time on a postnatal ward: experiences of mothers, infants, and staff.
- Background: PubMed 30068525Seashore C, Tully KP. Preventing Newborn Falls and Improving Care for Postpartum Women and Their Newborns. Hosp Pediatr. 2018 Sep;8(9):593-594. doi: 10.1542/hpeds.2018-0121. Epub 2018 Aug 1. No abstract available.
- Background: PubMed 36351359Grant D. The "Quiet Revolution" and the cesarean section in the United States. Econ Hum Biol. 2022 Dec;47:101192. doi: 10.1016/j.ehb.2022.101192. Epub 2022 Oct 17.
- BackgroundBrooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry 1996;189(194):4-7
- Background: PubMed 25411542Crenshaw JT. Healthy Birth Practice #6: Keep Mother and Baby Together- It's Best for Mother, Baby, and Breastfeeding. J Perinat Educ. 2014 Fall;23(4):211-7. doi: 10.1891/1058-1243.23.4.211.
- Background: PubMed 32154198Consales A, Crippa BL, Cerasani J, Morniroli D, Damonte M, Bettinelli ME, Consonni D, Colombo L, Zanotta L, Bezze E, Sannino P, Mosca F, Plevani L, Gianni ML. Overcoming Rooming-In Barriers: A Survey on Mothers' Perspectives. Front Pediatr. 2020 Feb 21;8:53. doi: 10.3389/fped.2020.00053. eCollection 2020.
- Background: PubMed 27885658Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.
- Background: PubMed 22596059McKeever J, Fleur RS. Overcoming barriers to Baby-Friendly status: one hospital's experience. J Hum Lact. 2012 Aug;28(3):312-4. doi: 10.1177/0890334412440627. Epub 2012 May 17.
- WHO/UNICEF StatementLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Tomori, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couplet Care Bassinet and Standard Bassinet in people with Breastfeeding and Sleep, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal reported infant wakings (time frame: Up to 3 days (until discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533449, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.