Couplet Care Bassinet for Mother and Infant Outcomes

Recruiting in Palo Alto (17 mi)

Overseen by Cecilia Tomori, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Multiple infants, Infant not rooming-in

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How is the Couplet Care Bassinet treatment different from other treatments for mother and infant outcomes?

The Couplet Care Bassinet is unique because it focuses on keeping mothers and infants together in the same space, which can enhance bonding and support breastfeeding, especially for twins and preterm infants. This approach differs from traditional care where infants might be separated from their mothers, potentially impacting breastfeeding success and maternal-infant interactions.

^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

Who can communicate in English

I have recently given birth.

I am 18 years old or older.

Exclusion Criteria

Postpartum female with multiple infants (twins or more)

Participant with an infant who is not rooming-in, such as for infant or maternal intensive care

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assigned either the standard bassinet or the Couplet Care bassinet and are monitored for maternal-infant outcomes

Up to 3 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and chart reviews

1 year

Surveys and assessments

Participant Groups

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.

Group I: Couplet Care Bassinet Experimental Treatment 1 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 Bassinet Active Control 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins Hospital Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Collaborator

Couplet Care LLC Collaborator

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Twin birth: an additional risk factor for poorer quality maternal interactions with very preterm infants? [2013] Twin birth can be considered an additional risk factor for poor interactions between mothers and their very preterm (VP;

2. England pubmed.ncbi.nlm.nih.gov

Breastfeeding initiation, duration, and experiences of mothers of late preterm twins: a mixed-methods study. [2022] Twins and late preterm (LPT) infants are at an increased risk of being breastfed to a lesser extent than term singletons. This study aimed to describe the initiation and duration of any and exclusive breastfeeding at the breast for mothers of LPT twins and term twins during the first 4 months and to explore the breastfeeding experiences of mothers of LPT twins.

3. Poland pubmed.ncbi.nlm.nih.gov

[Breast feeding of twins with regard to pre-term infants]. [2017] The benefits of breast-feeding for health and development pre-term and full-term infants changed the attitude towards nutrition of twins and higher-order multiples. Mothers of twins are often at risk of unsuccessful initiation of lactation while in hospital. The possibilities to provide appropriate intervention and support when a mother breastfeeds twins are presented.

4. New Zealand pubmed.ncbi.nlm.nih.gov

Can preterm twins breast feed successfully? [2004] To compare the success of singleton and twin preterm infants in establishing and maintaining breast feeding, and to evaluate the effectiveness of current programmes to promote breast feeding.

5. Japan pubmed.ncbi.nlm.nih.gov

Breast-feeding and bottle-feeding of twins, triplets and higher order multiple births. [2011] This study was performed to determine the rates of breast-feeding and/or bottle-feeding in mothers of twins, triplets and higher order multiple births compared to those in mothers of singletons, and identify factors associated with decision as to breast-feed or bottle-feed.