NCT06533449

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2025Jul 2026

First Submitted

Initial submission to the registry

July 17, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

July 17, 2024

Last Update Submit

August 4, 2025

Conditions

BreastfeedingSleepPatient Satisfaction

Keywords

skin-to-skinrooming-inbreastfeedingsleepbassinetCesarean Section

Outcome Measures

Primary Outcomes (1)

  • Maternal reported infant wakings

    Number of times mothers report infant waking

    Up to 3 days (until discharge)

Secondary Outcomes (7)

  • Post-Partum pain levels

    Up to 3 days (until discharge)

  • Infant feeding substance

    Up to 3 days (until discharge)

  • Length of postpartum hospitalization

    Up to 3 days (until discharge)

  • Number of minutes infants were outside of the post-natal unit

    Up to 3 days (until discharge)

  • Breastfeeding frequency

    Up to 3 days (until discharge)

  • +2 more secondary outcomes

Other Outcomes (3)

  • Clinician usability assessment

    1 year

  • Administrator adoptability assessment

    1 year

  • Satisfaction with Bassinet Design

    1 year

Study Arms (2)

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.

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.

Device: Standard Bassinet

Interventions

Couplet Care BassinetDEVICE

Couplet Care Bassinet

Couplet Care Bassinet
Standard BassinetDEVICE

Standard Bassinet

Standard Bassinet

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen giving birth
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postpartum female participant
  • at least 18 years of age
  • who can communicate in English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (10)

  • 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.

    PMID: 22914755BACKGROUND

  • Tully 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.

    PMID: 24252711BACKGROUND

  • Taylor, Catherine & Tully, Kristin & Ball, Helen. (2015). Night-time on a postnatal ward: experiences of mothers, infants, and staff.

    BACKGROUND

  • 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.

    PMID: 30068525BACKGROUND

  • Grant 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.

    PMID: 36351359BACKGROUND

  • Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry 1996;189(194):4-7

    BACKGROUND

  • 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.

    PMID: 25411542BACKGROUND

  • Consales 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.

    PMID: 32154198BACKGROUND

  • Moore 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.

    PMID: 27885658BACKGROUND

  • McKeever 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.

    PMID: 22596059BACKGROUND

Related Links

MeSH Terms

Conditions

Breast FeedingPatient Satisfaction

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Cecilia Tomori, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Tomori, PhD

CONTACT

2404416153ctomori1@jh.edu

Monica Brown, MS

CONTACT

667-306-9823mbrow374@jh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

August 1, 2024

Study Start

January 9, 2025

Primary Completion (Estimated)

May 29, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)