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ACTIVE NOT RECRUITING
NCT06052865
NA

Serial Brain MRI in Hospitalized Preterm Infants

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

The purpose of this research study is to use serial magnetic resonance imaging (MRI) to define the timing and factors associated with brain injury as well as the pattern of brain growth of very preterm infants during hospitalization in the neonatal intensive care unit (NICU). In addition, the goal is to utilize early MRI to risk-stratify preterm infants and tailor rehabilitative interventions according to risk in order to explore associations between NICU rehabilitative intervention and short- and long-term outcomes of preterm infants.

Official title: Serial Neuroimaging of Brain Injury and Brain Growth in the NICU in the Very Preterm Infant

Key Details

Gender

All

Age Range

22 Weeks - 33 Weeks

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2020-09-14

Completion Date

2029-09-14

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

BEHAVIORAL

SENSE-plus: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program

The SENSE II program was developed to engage parents in consistently providing positive, developmentally appropriate sensory exposures to their high-risk infants in the NICU every day of hospitalization. The SENSE II program includes specific doses and targeted timing (based on postmenstrual age) of evidence-based interventions of auditory, tactile, vestibular, kinesthetic, olfactory, and visual exposures to be conducted daily through hospitalization for preterm infants. Additionally, for very preterm infants with advanced neurological injury, additional 1-2 sessions of weekly motor therapy are added to the SENSE-II program

BEHAVIORAL

SENSE: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program

The SENSE II program was developed to engage parents in consistently providing positive, developmentally appropriate sensory exposures to their high-risk infants in the NICU every day of hospitalization. The SENSE II program includes specific doses and targeted timing (based on postmenstrual age) of evidence-based interventions of auditory, tactile, vestibular, kinesthetic, olfactory, and visual exposures to be conducted daily through hospitalization for preterm infants.

OTHER

Reference/ Standard of care

Infants in the Unexposed group receive the NICU standard of developmental care throughout hospitalization.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States