Recruiting

Doula Support

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT07437131

Conditions

Infant Admitted to Neonatal Intensive Care Unit (NICU)

Doula Support

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced doula support

Study Details

Brief summary:

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

Conditions

Infant Admitted to Neonatal Intensive Care Unit (NICU)

Doula Support

Study ID

NCT07437131

Start date

Mar 10, 2026

Status verified date

Mar, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • baby admitted to NICU at Women and Infants Hospital
  • anticipated NICU stay greater than or equal to 2 weeks
  • English or Spanish speaking

Exclusion Criteria:

  • Infant anticipated stay < 2 weeks

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Standard Care

Participants will receive usual clinical care with a baby admitted to the Neonatal Intensive Care Unit

experimental: Enhanced doula support

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.

Interventions

Enhanced doula support

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.

Primary outcome measure

  • Maternal stress [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Alisse Hauspurg, MD

401-274-1122ahauspurg@carene.org

Sarbattama Sen, MD

ssen@carene.org

Locations

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Research Assistant

401-274-1122nicudoulas@wihri.org

Principal Investigator:

Alisse Hauspurg, MD

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Apr 7, 2026

Last verified

Mar, 2026

Keywords

  • NICU, infant in NICU
  • doula support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2026-04-07.