60 Participants NeededMy employer runs this trial

Doula Support for Premature Birth

AH
SS
Overseen BySarbattama Sen, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Women and Infants Hospital of Rhode Island
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if pairing families who have a baby in the Neonatal Intensive Care Unit with a community doula improves stress. The main questions it aims to answer are:

Researchers will compare stress levels among families with a baby in the neonatal intensive care unit who are paired with a community doula compared to those who receive standard care.

Participants will:

Complete baseline surveys and physical assessments (blood pressure and blood sample collection) and again after six weeks If they are randomized to receive doula support, they will meet with the doula weekly to receive additional parental support for six weeks

Are You a Good Fit for This Trial?

Inclusion Criteria

* baby admitted to NICU at Women and Infants Hospital
* anticipated NICU stay greater than or equal to 2 weeks
I can speak English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys and physical assessments, including blood pressure and blood sample collection

1 week
1 visit (in-person)

Treatment

Participants receive enhanced doula support with weekly meetings for six weeks

6 weeks
6 visits (in-person)

Follow-up

Participants are monitored for stress, anxiety, depression, and other health outcomes

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced doula support

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced doula supportExperimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials
119
Recruited
59,200+