Community-partnered doula support for NICU families
Community-Partnered Doula Support for Neonatal Intensive Care Unit Families
This study will test whether pairing parents of NICU infants with a community doula for six weeks reduces parental stress compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT07437131 on ClinicalTrials.gov |
What this trial studies
This single-site, randomized pilot compares enhanced community doula support to standard care for parents of infants in the NICU at Women and Infants Hospital in Providence, RI. Participants complete baseline surveys and physical measures (blood pressure and a blood sample) and are reassessed at six weeks. Families randomized to the intervention meet weekly with a trained community doula for six weeks to receive emotional, informational, and advocacy support. The trial also includes an implementation evaluation to understand how doula services can be delivered and sustained in the NICU setting.
Who should consider this trial
Good fit: Parents or primary caregivers of infants admitted to the NICU at Women and Infants Hospital with an anticipated stay of two weeks or longer who speak English or Spanish.
Not a fit: Parents of infants expected to be in the NICU for less than two weeks, those receiving care outside Women and Infants Hospital, or those who do not speak English or Spanish are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could reduce parental stress, depression, and anxiety and improve parent engagement and health during their infant's NICU stay.
How similar studies have performed: Doula support has shown benefits in other perinatal settings, but randomized doula interventions have not previously been conducted in the NICU, making this a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Providence, Rhode Island
- Women and Infants Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Alisse Hauspurg, MD
- Email: ahauspurg@carene.org
- Phone: 401-274-1122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.