RECRUITING

Sensory Optimization of the Hospital Environment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.

Official Title

Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit

Quick Facts

Study Start:2023-05-29
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05230199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 7 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * ≤ 32 weeks estimated gestational age (EGA)
  2. * recruited within the first week of life
  1. * \> 32 weeks EGA at birth
  2. * \>7 days old
  3. * become wards of the state
  4. * have a suspected or confirmed congenital anomaly
  5. * face a high immediate threat of death, per the opinion of the attending physician.

Contacts and Locations

Study Contact

Roberta Pineda, PhD OTR/L
CONTACT
(323) 442-2850
bobbi.pineda@chan.usc.edu
Amit Mathur, MD
CONTACT
314) 577-5642
amit.mathur@health.slu.edu

Principal Investigator

Roberta Pineda, PhD OTR/L
PRINCIPAL_INVESTIGATOR
University of Southern California
Amit Mathur, MD
PRINCIPAL_INVESTIGATOR
St. Louis University

Study Locations (Sites)

Cardinal Glennon Children's Hospital
Saint Louis, Missouri, 63104
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Roberta Pineda, PhD OTR/L, PRINCIPAL_INVESTIGATOR, University of Southern California
  • Amit Mathur, MD, PRINCIPAL_INVESTIGATOR, St. Louis University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-29
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-05-29
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Preterm
  • Parent-Child Relations
  • Parents
  • Development, Infant
  • Sensory Integration Dysfunction