Health Screening and Referral for Premature Birth

Recruiting at 6 trial locations

Overseen By Margaret Parker, MD, MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Massachusetts, Worcester

No Placebo Group

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.

Research Team

Margaret Parker, MD, MPH

Principal Investigator

University of Massachusetts Chan Medical School

Arvin Garg, MD, MPH

Principal Investigator

University of Massachusetts Chan Medical School

Mari-Lynn Drainoni, PhD, MEd

Principal Investigator

Boston University Chobanian and Avedisian School of Medicine

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

Treatment Details

Interventions

• Implementation of social determinants of health screening and referral (Behavioural Intervention)

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+