Serial Brain MRI in Hospitalized Preterm Infants

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.

Conditions

• Preterm Birth Complication

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.

Sponsors & Collaborators

• POM Wonderful LLC

  collaborator INDUSTRY

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Carmina Erdei, MD · Brigham and Women's Hospital and Harvard Medical School

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

22 Weeks

Max Age

33 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-14

Primary Completion

2026-09-01

Completion

2029-09-14

Countries

• United States

Study Locations