Couplet Care Bassinet for Mother and Infant Outcomes

Overseen By Monica Brown, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Multiple infants, Infant not rooming-in

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 days

500 Participants Needed

Trial Summary

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}

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.

Research Team

Cecilia Tomori, PhD

Principal Investigator

Johns Hopkins University

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.

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

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

Treatment Details

Interventions

• Couplet Care Bassinet

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Couplet Care LLC

Collaborator

Trials

1

Recruited

500+

Findings from Research

Mothers of very preterm twins experience higher levels of parenting stress and show lower responsiveness in interactions compared to mothers of singletons, indicating a greater challenge in caregiving.

Twin infants demonstrate poorer communication skills, as evidenced by lower interaction scores at both hospital discharge and three months corrected age, which may contribute to the increased stress experienced by their mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twin birth: an additional risk factor for poorer quality maternal interactions with very preterm infants? Beer, C., Israel, C., Johnson, S., et al.[2013]

Both mothers of late preterm (LPT) twins and term twins initiated breastfeeding at high rates (100% and 96%, respectively), but by 4 months, significantly fewer mothers of LPT twins continued breastfeeding (44% vs. 75% for term twins).

Mothers of LPT twins faced unique challenges, such as their infants' immature breastfeeding behaviors and a lack of support from healthcare professionals, which led to questioning the value of their efforts and ultimately contributed to a higher cessation rate of breastfeeding compared to mothers of term twins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding initiation, duration, and experiences of mothers of late preterm twins: a mixed-methods study. Jonsdottir, RB., Flacking, R., Jonsdottir, H.[2022]

Breastfeeding has significant health and developmental benefits for both pre-term and full-term infants, which has led to a shift in how nutrition is approached for twins and higher-order multiples.

Mothers of twins face challenges in starting breastfeeding while in the hospital, highlighting the need for targeted interventions and support to help them successfully initiate lactation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Breast feeding of twins with regard to pre-term infants]. Mikiel-Kostyra, K.[2017]

Preterm twins can establish and maintain breastfeeding as successfully as preterm singleton infants, with 89% of twins and 93% of singletons breastfeeding at discharge from the hospital.

The breastfeeding rates declined similarly for both groups, with 68% breastfeeding at 8-12 weeks and 49% at 12-16 weeks after birth, indicating that with proper support, preterm infants can achieve breastfeeding rates comparable to term infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can preterm twins breast feed successfully? Liang, R., Gunn, AJ., Gunn, TR.[2004]

Mothers of twins and higher order multiples (triplets and beyond) are significantly more likely to choose bottle-feeding compared to mothers of singletons, and they tend to breast-feed for shorter durations when they do breast-feed.

Factors influencing the decision to bottle-feed include lack of husband cooperation in childrearing and higher levels of anxiety regarding the multiple pregnancy, with mothers experiencing these issues being 1.83 and 1.73 times more likely to choose bottle-feeding, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast-feeding and bottle-feeding of twins, triplets and higher order multiple births. Yokoyama, Y., Ooki, S.[2011]

References

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

Twin birth: an additional risk factor for poorer quality maternal interactions with very preterm infants? [2013]

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

Breastfeeding initiation, duration, and experiences of mothers of late preterm twins: a mixed-methods study. [2022]

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

[Breast feeding of twins with regard to pre-term infants]. [2017]

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

Can preterm twins breast feed successfully? [2004]

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

Breast-feeding and bottle-feeding of twins, triplets and higher order multiple births. [2011]