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Behavioural Intervention
Health Screening and Referral for Premature Birth
N/A
Waitlist Available
Led By Arvin Garg, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 7, 9, and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help families with premature babies who are facing social challenges like unstable housing or job insecurity. These challenges can negatively impact the health of the premature babies, affecting their overall development. The study
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 7, 9, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 7, 9, and 12 months
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Social needs screening and referral careExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,746,825 Total Patients Enrolled
72 Trials studying Premature Birth
121,819 Patients Enrolled for Premature Birth
University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
991,838 Total Patients Enrolled
3 Trials studying Premature Birth
652 Patients Enrolled for Premature Birth
Arvin Garg, MD, MPHPrincipal InvestigatorUniversity of Massachusetts Chan Medical School
3 Previous Clinical Trials
2,408 Total Patients Enrolled
Margaret Parker, MD, MPHPrincipal InvestigatorUniversity of Massachusetts Chan Medical School
Mari-Lynn Drainoni, PhD, MEdPrincipal InvestigatorBoston University Chobanian and Avedisian School of Medicine