Health Screening and Referral for Premature Birth

Recruiting at 6 trial locations

Overseen By Margaret Parker, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Infant death, Late discharge, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

882 Participants Needed

Trial Summary

What is the purpose of this trial?

Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH). Preterm infants are especially vulnerable to the social conditions they grow up in, with sustained impacts on function across multiple organ systems. The goal of this study is to translate an established model of SDOH screening and referral from the outpatient setting to the NICU, thereby maximizing the potential to offset the effects of adverse SDOH on vulnerable mother-preterm infant dyads.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Implementation of social determinants of health screening and referral for premature birth?

Research shows that addressing social determinants of health (like access to resources and support) during prenatal care can significantly impact the health of mothers and infants, potentially reducing risks associated with preterm birth. ^{1 2 3 4 5}

Is the health screening and referral for premature birth generally safe for humans?

The research articles provided do not contain specific safety data for the health screening and referral treatment for premature birth or its related interventions. ^{6 7 8 9 10}

How is the treatment for premature birth using social determinants of health screening and referral different from other treatments?

This treatment is unique because it focuses on identifying and addressing social factors that can affect health, such as access to resources and support, rather than just medical factors. It involves screening for these social determinants and providing referrals to appropriate services, which is not a standard approach in traditional medical treatments for premature birth. ^{1 2 3 4 11}

Research Team

Mari-Lynn Drainoni, PhD, MEd

Principal Investigator

Boston University Chobanian and Avedisian School of Medicine

Margaret Parker, MD, MPH

Principal Investigator

University of Massachusetts Chan Medical School

Arvin Garg, MD, MPH

Principal Investigator

University of Massachusetts Chan Medical School

Eligibility Criteria

This trial is for families with preterm infants who may be facing social challenges like not having a stable place to live or job security. It aims to help those in the NICU by identifying and addressing these issues.

Inclusion Criteria

I can speak and read either English or Spanish.

Infant gestational age <34 weeks' gestation; singleton or multiple

My infant has been in the hospital for at least 14 days.

Exclusion Criteria

My baby was discharged from the hospital after reaching 52 weeks of age, counting from conception.

Mothers or infants who die before anticipated infant discharge

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care Phase

Sites participate in the usual care phase before the intervention begins

Varies by site

Experimental Phase

Implementation of SDOH screening and referral models in NICUs

Approximately 12 months

Monthly visits for data collection

Sustainment Phase

Continued screening and referral after active intervention

Approximately 6 months

Follow-up

Participants are monitored for outcomes such as maternal mental health and infant development

12 months post-NICU discharge

Treatment Details

Interventions

• Implementation of social determinants of health screening and referral

Trial Overview The study is testing a program that screens for social problems affecting health and helps families find resources. It's taking an approach used in outpatient settings and applying it to the NICU environment.

Participant Groups

Group I: Social needs screening and referral care Experimental Treatment 1 Intervention

As a step wedge cluster randomized trial all sites will be assigned to receive the intervention in a randomized order. There is no difference in the intervention by site, the only difference is the timing of the beginning of the intervention. Therefore, we have only identified one arm.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Approaches to addressing social determinants of health in the NICU: a mixed methods study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Screening and Referral for Social Determinants of Health: Maternity Patient and Health Care Team Perspectives. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Screening for Social Determinants of Health During Prenatal Care: Why, What, and How. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

"We Don't Want to Screen for the Sake of Screening": A Qualitative Evaluation of a Social Needs Screening and Referral Intervention in the NICU. [2023]

5. Iran pubmed.ncbi.nlm.nih.gov

Relationship between Structural and Intermediary Determinants of Health and Preterm Delivery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sociodemographic and Biological Factors of Health Disparities of Mothers and Their Very Low Birth-Weight Infants. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Multilevel Intervention to Reduce Preterm Birth Among Black Women in Newark, New Jersey: A Controlled Interrupted Time Series Analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Prematurity--infant mortality: the scourge remains. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

National Trends in Preterm Infant Mortality in the United States by Race and Socioeconomic Status, 1995-2020. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Risk and Protective Factors for Preterm Birth Among Black Women in Oakland, California. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

An Integrative Review of Social Determinants of Health Screenings used in Primary Care Settings. [2021]