Infant Admitted to Neonatal Intensive Care Unit (NICU)NCT07437131
Community-Partnered Doula Support for Neonatal Intensive Care Unit Families
A study testing Enhanced doula support in people with Infant Admitted to Neonatal Intensive Care Unit (NICU) and Doula Support, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infant Admitted to Neonatal Intensive Care Unit (NICU), Doula Support
- What is being tested?
- Enhanced doula support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- baby admitted to NICU at Women and Infants Hospital
- anticipated NICU stay greater than or equal to 2 weeks
- English or Spanish speaking
Who cannot join
- Infant anticipated stay < 2 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarbattama Sen, MD contact
United States1 site, 1 recruiting
- Recruiting
Women and Infants Hospital
Providence, Rhode Island, 02905
Research Assistant, 401-274-1122, nicudoulas@wihri.org
Alisse Hauspurg, MD
About this study
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
Read the detailed description
One in eight babies are admitted to the Neonatal Intensive Care Unit (NICU) in Rhode Island due to pregnancy or neonatal complications. Approximately half of NICU parents experience clinically significant levels of depression, anxiety and trauma. Structural and institutional barriers and unmet health-related social needs limit healthcare access, adversely impacting outcomes in NICU families. Innovative solutions to support NICU families are urgently needed. Doula care is recommended by The Department of Health and Human Services to provide emotional, physical, and informational support and advocacy. Despite the vulnerability of NICU families, doula care has not been trialed in the NICU setting. The overall goal of this line of research is to address the challenges that families face in the NICU through our novel community-partnered doula intervention. In this application, the objective is to conduct a single-site type 1 hybrid effectiveness-implementation pilot study of a NICU-based parental doula care program. This will be achieved through two specific aims: (1) to evaluate whether enhanced doula care compared to treatment as usual in NICU families, improves parental stress and (2) To conduct a summative evaluation of the implementation of doula care in the NICU. Our central hypothesis is that doula care rooted will improve parental emotional and physical health outcomes with NICU infants. The research proposed in this application is innovative as it provides the first rigorous evidence for incorporating community-partnered doula care into the NICU setting. This proposal is significant as it will adapt an evidence-based, multi-level approach to improve outcomes and meet the needs of high-risk NICU families. The investigators anticipate that our evidence-based, community-driven approach will be a first step towards a scalable, and sustainable strategy to improve health outcomes for NICU families. Our findings will provide a valuable framework to generate data to support a subsequent large-scale randomized trial of enhanced doula support in NICU families, incorporating a proposed community co-leadership model. Through evaluation of implementation, the investigators will gather critical data to inform implementation strategies to scale doula care in the NICU. These innovations in care practices will provide a rigorous evidence base to further develop and support community partnerships in other NICUs, and to advocate for spread of legislation needed to sustain such interventions across the United States to benefit all Americans.
- Being tested
- Enhanced doula support
- Keywords
- NICU, infant in NICU, doula support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced doula supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants will receive usual clinical care with a baby admitted to the Neonatal Intensive Care Unit |
| Enhanced doula support | Experimental | 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. Receives: Behavioral: Enhanced doula support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal stress
Maternal stress as measured by perceived stress scale (PSS): NICU (range: 0-230, higher score indicates worse outcome)
Measured: 6 weeks
Secondary outcomes (7)
Mean arterial pressure
Mean arterial blood pressure
Measured: 6 weeks
Diastolic blood pressure
Mean diastolic blood pressure
Measured: 6 weeks
Systolic blood pressure
Mean systolic blood pressure
Measured: 6 weeks
Anxiety
Anxiety as measured by Generalized Anxiety Disorder-7 (GAD-7) (range: 0-21, higher score indicates worse outcome)
Measured: 6 weeks
Depression
Depression as measured by Edinburgh Postnatal Depression Scale (EPDS) (range: 0-30, higher score indicates worse outcome)
Measured: 6 weeks
Experiences of care
Experience of care as measured by Family-Centered Care Scale in Neonatal Intensive Care Unit (FCCS-NICU) (range: 1-5, lower score indicates worse outcome)
Measured: 6 weeks
Post-traumatic stress
Post-traumatic stress scores measured by Modified Perinatal Post-traumatic Stress Disorder Questionnaire (PPQ-II) (range: 0-56, higher score indicates a worse outcome)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start10 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Admitted to Neonatal Intensive Care Unit (NICU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437131
- Sponsor's protocol ID
- WIH 25-0026
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Partnered Doula Support for Neonatal Intensive Care Unit Families
- ClinicalTrials.gov ID
- NCT07437131
- Acronym / sponsor ID
- WIH 25-0026
- Keywords
- NICU, infant in NICU, doula support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
One in eight babies are admitted to the Neonatal Intensive Care Unit (NICU) in Rhode Island due to pregnancy or neonatal complications. Approximately half of NICU parents experience clinically significant levels of depression, anxiety and trauma. Structural and institutional barriers and unmet health-related social needs limit healthcare access, adversely impacting outcomes in NICU families. Innovative solutions to support NICU families are urgently needed. Doula care is recommended by The Department of Health and Human Services to provide emotional, physical, and informational support and advocacy. Despite the vulnerability of NICU families, doula care has not been trialed in the NICU setting. The overall goal of this line of research is to address the challenges that families face in the NICU through our novel community-partnered doula intervention. In this application, the objective is to conduct a single-site type 1 hybrid effectiveness-implementation pilot study of a NICU-based parental doula care program. This will be achieved through two specific aims: (1) to evaluate whether enhanced doula care compared to treatment as usual in NICU families, improves parental stress and (2) To conduct a summative evaluation of the implementation of doula care in the NICU. Our central hypothesis is that doula care rooted will improve parental emotional and physical health outcomes with NICU infants. The research proposed in this application is innovative as it provides the first rigorous evidence for incorporating community-partnered doula care into the NICU setting. This proposal is significant as it will adapt an evidence-based, multi-level approach to improve outcomes and meet the needs of high-risk NICU families. The investigators anticipate that our evidence-based, community-driven approach will be a first step towards a scalable, and sustainable strategy to improve health outcomes for NICU families. Our findings will provide a valuable framework to generate data to support a subsequent large-scale randomized trial of enhanced doula support in NICU families, incorporating a proposed community co-leadership model. Through evaluation of implementation, the investigators will gather critical data to inform implementation strategies to scale doula care in the NICU. These innovations in care practices will provide a rigorous evidence base to further develop and support community partnerships in other NICUs, and to advocate for spread of legislation needed to sustain such interventions across the United States to benefit all Americans.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants will receive usual clinical care with a baby admitted to the Neonatal Intensive Care Unit |
| Enhanced doula support | Experimental | Behavioral: Enhanced doula supportThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- baby admitted to NICU at Women and Infants Hospital
- anticipated NICU stay greater than or equal to 2 weeks
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Infant anticipated stay < 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced doula supportThe 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. | Behavioural | Enhanced doula support |
Primary outcome
Maternal stress
Time frame: 6 weeks
Maternal stress as measured by perceived stress scale (PSS): NICU (range: 0-230, higher score indicates worse outcome)
7 secondary outcomes
Mean arterial pressure
Time frame: 6 weeks
Diastolic blood pressure
Time frame: 6 weeks
Systolic blood pressure
Time frame: 6 weeks
Anxiety
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Experiences of care
Time frame: 6 weeks
Post-traumatic stress
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarbattama Sen, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced doula support in people with Infant Admitted to Neonatal Intensive Care Unit (NICU) and Doula Support, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisse Hauspurg, MD (401-274-1122 ext. 47451, ahauspurg@carene.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal stress (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.