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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years corrected age

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I was born prematurely, before 33 weeks of pregnancy were completed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Incidence of parental stress (optional parent questionnaire)

Parent sense of competency (optional parent questionnaire)

Parent-reported child developmental performance (optional parent questionnaire)

+2 more

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,873 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary aim of this research project?

"The primary evaluation for this 3-month study will be the incidence and severity of white matter injury on early MRI scans prior to term age in very preterm infants. Optional parent questionnaires assessing child development, autism risk, and parental stress levels are also part of secondary outcomes. For the developmental performance measure, scores from the Ages and Stages Questionnaire (ASQ) ranging from 0-60 with higher values implying better results will be compared against established norms; alternatively, Modified Checklist for Autism Revised (M-CHAT R) Toddler version scoring from 0-20 with High Risk being 8 or above is used as a metric for autism"

Answered by AI

Are the criteria for this trial compatible with my profile?

"In order to participate in this trial, participants must have had a preterm birth between 22 and 33 weeks. 75 individuals are needed for the study."

Answered by AI

Is the research team actively seeking participants for this experiment?

"This research endeavour, initially posted on September 14th 2020 is still in search of suitable participants. The latest edition to this clinical trial was made on 19/09/2023 according to the information provided byclinicaltrials.gov ."

Answered by AI

What is the maximum capacity of individuals taking part in this clinical experiment?

"Yes, according to the information on clinicaltrials.gov this study is actively looking for participants. It was first posted 14th September 2020 and last updated 19th September 2023. This research requires 75 individuals across a single site."

Answered by AI

Are senior citizens excluded from participating in this research trial?

"This study has specified that patients between 22 and 33 weeks of age are eligible to apply. There are also 188 other trials for those younger than 18 years old, while 78 studies have been established for people aged 65 or older."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Serial Brain MRI in Hospitalized Preterm Infants

Carmina Erdei, MD 2020. "Serial Brain MRI in Hospitalized Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052865.

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