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Behavioural Intervention

Social needs screening and referral care for Premature Birth

N/A
Waitlist Available
Led By Margaret Parker, MD, MPH
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Infant gestational age \<34 weeks' gestation; singleton or multiple.
* Infant hospitalized for at least 14 days of life (to allow for SDOH screening/referral and contact with resources if applicable).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 7, 9, and 12 months
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves screening and referrals rather than medical treatments, there are no direct physical side effects. However, participants might experience stress or anxiety during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 7, 9, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 7, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Penetration of SDOH intervention
Receipt of ANY Community Resource
Secondary study objectives
Acceptability of SDOH intervention
Equity of implementation
Equity of receipt of community resources
+20 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Social needs screening and referral careExperimental Treatment1 Intervention

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,990 Previous Clinical Trials
2,683,553 Total Patients Enrolled
66 Trials studying Premature Birth
119,510 Patients Enrolled for Premature Birth
University of Massachusetts, WorcesterLead Sponsor
352 Previous Clinical Trials
989,984 Total Patients Enrolled
2 Trials studying Premature Birth
232 Patients Enrolled for Premature Birth
Margaret Parker, MD, MPHPrincipal InvestigatorUniversity of Massachusetts Chan Medical School
~588 spots leftby Dec 2027
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