Health TrialsbyHealthPanel

Community-Partnered Doula Support for Neonatal Intensive Care Unit Families

ConditionsInfant Admitted to Neonatal Intensive Care Unit (NICU)Doula Support
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen and Infants Hospital of Rhode Island

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

baby admitted to NICU at Women and Infants Hospital

anticipated NICU stay greater than or equal to 2 weeks

English or Spanish speaking

Disqualifiers

Infant anticipated stay < 2 weeks

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced doula support

    Behavioral

    The doula intervention will be delivered by a dedicated postpartum NICU doula. The postpartum doula will provide one-on-one support at least weekly for a period of six weeks, to intensively engage and support participants, reinforce health behavior education, and screen for and help families to access quality medical care, mental health and social needs support.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard CareNo intervention 0 interventions
Group B: Enhanced doula supportExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maternal stress

Maternal stress as measured by perceived stress scale (PSS): NICU (range: 0-230, higher score indicates worse outcome)

Time frame
6 weeks

Secondary outcomes

1

Mean arterial pressure

Mean arterial blood pressure

Time frame
6 weeks
2

Diastolic blood pressure

Mean diastolic blood pressure

Time frame
6 weeks
3

Systolic blood pressure

Mean systolic blood pressure

Time frame
6 weeks
4

Anxiety

Anxiety as measured by Generalized Anxiety Disorder-7 (GAD-7) (range: 0-21, higher score indicates worse outcome)

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women and Infants Hospital of Rhode Island

Lead sponsor

Source ClinicalTrials.gov
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