882 Participants Needed

Health Screening and Referral for Premature Birth

Recruiting at 6 trial locations
AE
MP
Overseen ByMargaret Parker, MD, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.678911

Who Is on the Research Team?

MD

Mari-Lynn Drainoni, PhD, MEd

Principal Investigator

Boston University Chobanian and Avedisian School of Medicine

AG

Arvin Garg, MD, MPH

Principal Investigator

University of Massachusetts Chan Medical School

MP

Margaret Parker, MD, MPH

Principal Investigator

University of Massachusetts Chan Medical School

Are You a Good Fit for This Trial?

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.
See 3 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Social needs screening and referral careExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Approaches to addressing social determinants of health in the NICU: a mixed methods study. [2023]
Screening and Referral for Social Determinants of Health: Maternity Patient and Health Care Team Perspectives. [2023]
Screening for Social Determinants of Health During Prenatal Care: Why, What, and How. [2023]
"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]
Relationship between Structural and Intermediary Determinants of Health and Preterm Delivery. [2022]
Sociodemographic and Biological Factors of Health Disparities of Mothers and Their Very Low Birth-Weight Infants. [2023]
Evaluation of a Multilevel Intervention to Reduce Preterm Birth Among Black Women in Newark, New Jersey: A Controlled Interrupted Time Series Analysis. [2022]
Prematurity--infant mortality: the scourge remains. [2022]
National Trends in Preterm Infant Mortality in the United States by Race and Socioeconomic Status, 1995-2020. [2023]
Risk and Protective Factors for Preterm Birth Among Black Women in Oakland, California. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
An Integrative Review of Social Determinants of Health Screenings used in Primary Care Settings. [2021]
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