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Behavioral Intervention
Sensory Enhancement Programs for Preterm Infants
N/A
Recruiting
Led By Carmina Erdei, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Born before 33 weeks completed gestational age
Be younger than 18 years old
Must not have
Confirmed or suspected congenital anomaly or genetic syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years corrected age
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at preterm babies' brain injury, growth, and how interventions can improve short and long-term outcomes.
Who is the study for?
This trial is for very preterm infants currently in the BWH NICU, born before 33 weeks of gestation and weighing between 0.5-4.5 kg who are stable according to their care team. Infants with congenital anomalies, genetic syndromes, or TORCH infections cannot participate.
What is being tested?
The study uses serial MRI scans to understand brain injury timing and growth patterns in hospitalized preterm infants. It also aims to personalize rehabilitative interventions based on early MRI risk assessments and examine their impact on infant outcomes.
What are the potential side effects?
Since this trial involves standard care procedures and non-invasive imaging like MRIs, there are minimal side effects expected; however, the usual risks associated with handling preterm infants for any medical procedure apply.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was born prematurely, before 33 weeks of pregnancy were completed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a confirmed or suspected genetic condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years corrected age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years corrected age
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence and severity of brain injury on term equivalent brain MRI in very preterm infants
Incidence and severity of white matter injury on early brain MRI before term-equivalent age for very preterm infants
Secondary study objectives
Incidence of parental stress (optional parent questionnaire)
Parent sense of competency (optional parent questionnaire)
Parent-reported child developmental performance (optional parent questionnaire)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Reference/ Standard of careExperimental Treatment1 Intervention
25 very preterm infants with no study exposure/ standard of care
Group II: Exposed: Low neurological riskExperimental Treatment1 Intervention
25 very preterm infants with low/no neurological injury
Group III: Exposed: High neurological riskExperimental Treatment1 Intervention
25 very preterm infants with advanced neurological injury
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,191 Total Patients Enrolled
12 Trials studying Premature Birth
3,092 Patients Enrolled for Premature Birth
POM Wonderful LLCIndustry Sponsor
14 Previous Clinical Trials
1,651 Total Patients Enrolled
Carmina Erdei, MDPrincipal InvestigatorBrigham and Women's Hospital and Harvard Medical School