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Behavioural Intervention

Infant Carrier for Breastfeeding

N/A

Recruiting

Research Sponsored by Nurturely

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postpartum week 6, 12, 24, 52

Awards & highlights

Study Summary

This trial aims to address suboptimal postpartum health outcomes in the US, especially among Black birthing parents and infants who are at the highest risk. The previous study showed that using soft infant

Who is the study for?

This trial is for Black birthing parents who are over 18, currently pregnant with one baby, fluent in a study language, have internet access via smartphone, an email account, and can physically and mentally use an infant carrier. They must be part of a participating agency.Check my eligibility

What is being tested?

The trial tests whether using soft infant carriers increases lactation rates and decreases postpartum depression among Black birthing parents. It's based on previous successful trials in Latinx communities and integrates culturally specific care within perinatal home visiting programs.See study design

What are the potential side effects?

There may not be direct side effects from using the infant carrier; however, participants should consider comfort levels or potential physical strain associated with carrying their infants for extended periods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postpartum week 6, 12, 24, 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postpartum week 6, 12, 24, 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and postpartum week 6, 12, 24, 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cultural Models of Infant Care Score of Each Participant

Depression Scale Score of Each Participant

Lactation Frequency of Each Participant

+2 more

Secondary outcome measures

Average Crying Frequency of Infant

Mother to Infant Bonding Scale Score

Participant Ability to Access Human Milk Score

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Infant CarrierExperimental Treatment1 Intervention

In the intervention group, in the prenatal period (~37 weeks gestation) will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client in practicing using the carrier and will provide materials to support continued learning.

Group II: Infant Carrier WaitlistActive Control1 Intervention

Participants assigned to the waitlist control will receive home visitation care as usual. At 6-months postpartum they will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client in practicing using the carrier and will provide materials to support continued learning.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

NurturelyLead Sponsor

1 Previous Clinical Trials

101 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals receiving medical care as part of this clinical trial?

"Yes, the details on clinicaltrials.gov highlight that this investigation is actively seeking volunteers. The trial was first posted on January 8th, 2024 and last revised on March 20th, 2024. A total of 400 individuals are sought for participation at a single site."

Answered by AI

Are researchers currently seeking participants for this study?

"As per clinicaltrials.gov, this investigation is actively enrolling participants. The trial was initially uploaded on January 8th, 2024, and the most recent update was made on March 20th of the same year."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"During weeks 6, 12, and 24 postpartum, this clinical research aims to evaluate the duration of lactation in each participant. Additional outcomes encompass the Participant Breastfeeding Self-Efficacy Score as per the Breastfeeding Self-Efficacy Scale - Short Form with a range from 14 to 70 indicating confidence levels in breastfeeding. The Participant Responsiveness to Infant Feeding Cues Score is determined by the Nurturely Feeding Responsiveness Scale ranging from 9 to 45 reflecting attentiveness to infant signals during feeding sessions. Lastly, the Mother-to-Infant Bonding Scale Score gauges bonding levels on a"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Carrying for the Culture

Emily Little 2024. "Carrying for the Culture". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06148831.