Health Screening and Referral for Premature Birth

Enrolling by invitation at 7 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?

This trial aims to assist families with preterm infants by connecting them to social resources such as housing or job support. Preterm babies often encounter health challenges, and enhancing their social environment can significantly impact their well-being. The trial will evaluate whether offering these services in the NICU (Neonatal Intensive Care Unit) setting, through the implementation of social determinants of health screening and referral, can improve outcomes for these vulnerable babies and their families. It is suitable for mothers who will care for their infants at home in the U.S. for at least a year after discharge and can speak and read English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could greatly enhance support systems for families with preterm infants.

Will I have to stop taking my current medications?

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

What prior data suggests that this protocol is safe for preterm infants and their families?

Research has shown that addressing social factors can improve the health of preterm babies and their families. These factors include stable housing, secure employment, and access to healthcare. This trial does not involve medication or medical procedures. Instead, it focuses on assessing family needs and connecting them to helpful resources.

As the trial involves screening and referrals, it is safe. There are no medical risks because it involves support services, not medical treatments. The aim is to provide families with necessary resources, which is not expected to cause harm. In fact, it seeks to enhance the health of both babies and their families by addressing unmet social needs.12345

Why are researchers excited about this trial?

Unlike traditional treatments for preventing premature birth that often focus solely on medical interventions, the social determinants of health screening and referral is unique because it targets the underlying social factors that can contribute to preterm birth, such as housing instability, food insecurity, and access to healthcare. Researchers are excited about this approach because it aims to address root causes and could lead to more sustainable, long-term benefits for maternal and fetal health. By implementing a comprehensive screening and referral system, this method has the potential to personalize care and improve outcomes by connecting individuals to necessary social resources and support networks.

What evidence suggests that this screening and referral method is effective for addressing social needs in preterm infants?

Research shows that improving factors like housing and access to resources greatly benefits infant health. Studies have found that issues such as lack of prenatal care or unstable housing lead to poorer health for babies. By identifying these issues and connecting families to resources, these problems can be addressed early. Previous efforts elsewhere have shown that providing families with necessary support improves health outcomes. This trial will implement social determinants of health screening and referral in neonatal intensive care units (NICUs) to evaluate its effectiveness, aiming for similar positive results.12356

Who Is on the Research Team?

MP

Margaret Parker, MD, MPH

Principal Investigator

University of Massachusetts Chan Medical School

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

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
Mother and infant are alive
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

The Social Determinants of Health Screening and Referral ...The goal of this study is to implement SDOH screening and referral models in 7 safety net NICUs, examining their potential to offset the effects of adverse SDOH ...
The impact of social determinants of health on infant and ...Abuse during pregnancy, access to prenatal care, housing, and education were all significantly associated with poorer infant health outcomes.
Gaining a deeper understanding of social determinants ...This review focuses on the role of social determinants of health (SDH), with an emphasis on maternal stress, in PTB disparity and biological embedding.
Provider and Staff Perspectives on Screening and Referral ...We studied clinical stakeholders' perspectives on SDOH screening and referral knowledge, priority, challenges, and opportunities across four hospital- ...
Health Screening and Referral for Premature BirthResearch shows that addressing social determinants of health (like access to resources and support) during prenatal care can significantly impact the health of ...
The impact of social determinants of health on infant and ...Abuse during pregnancy, access to prenatal care, housing, and education were all significantly associated with poorer infant health outcomes.
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