Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533449
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Development of the Couplet Care Bassinet
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of the Couplet Care Bassinet to Support Safe Implementation of Skin-to-skin Contact and rooming-in on Postnatal Units
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mothers 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
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 mothers 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 Childrens 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 US 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 US women who deliver by cesarean section as the mothers limited ability to move and postpartum pain hinder timely and safe infant care undermine breastfeeding impede the mothers 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 mothers 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
1 Evaluate the impact of the Couplet Care bassinet on maternal-infant patient outcomes in a powered randomized controlled trial RCT
2 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 dropsfalls and suffocation maternal waking from unmet infant needs and demands on nurses for assistance for non-medical needs
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
1 Evaluate the impact of the Couplet Care bassinet on maternal-infant patient outcomes in a powered randomized controlled trial RCT
2 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 dropsfalls and suffocation maternal waking from unmet infant needs and demands on nurses for assistance for non-medical needs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None