Parent-Child Relations Clinical Trial
— SOOTHEOfficial title:
Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit
NCT number | NCT05230199 |
Other study ID # | R01HD105557 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 29, 2023 |
Est. completion date | March 2027 |
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.
Status | Recruiting |
Enrollment | 215 |
Est. completion date | March 2027 |
Est. primary completion date | August 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 7 Days |
Eligibility | Inclusion Criteria: - = 32 weeks estimated gestational age (EGA) - recruited within the first week of life Exclusion Criteria: - > 32 weeks EGA at birth - >7 days old - become wards of the state - have a suspected or confirmed congenital anomaly - face a high immediate threat of death, per the opinion of the attending physician. |
Country | Name | City | State |
---|---|---|---|
United States | Cardinal Glennon Children's Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Harvard University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., St. Louis Children's Hospital, St. Louis University, University of North Carolina, Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Home Observation Measurement of the Environment | self report measure of the home environment | At 6 months, one and two years adjusted age | |
Other | Family Resilience Assessment Scale | self report measure of family resilience | At 6 months, one and two years adjusted age | |
Primary | Bayley Scales of Infant Toddler Development, 4th Edition, language outcome | Standardized assessment of language; The highest possible score on the language domain is 19 and the lowest possible score is 1. Scores from 8-12 are considered average. | 2 years adjusted age is primary outcome; also will be done at 1 year adjusted | |
Secondary | Bayley Scales of Infant Toddler Development, 4th Edition, motor outcome | Standardized assessment of motor; The highest possible score on the motor domain is 19 and the lowest possible score is 1. Scores from 8-12 are considered average. | 1 and 2 years adjusted age | |
Secondary | Bayley Scales of Infant Toddler Development, 4th Edition, cognitive outcome | Standardized assessment of cognition: The highest possible score on the cognitive domain is 19 and the lowest possible score is 1. Scores from 8-12 are considered average. | 1 and 2 years adjusted age | |
Secondary | NICU Network Neurobehavioral Assessment Scale | Standardized neonatal neurobehavioral assessment | Between 35-41 weeks PMA | |
Secondary | Sensory Profile 2 | Parent-report measure of sensory processing | Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age, | |
Secondary | Modified Checklist for Autism in Toddlers | Parent report measure of sensory features | 2 years adjusted age | |
Secondary | Ages and Stages Questionnaire-3 | parent report measure of development | 6 months adjusted age. | |
Secondary | Child Behavior Checklist (CBCL) | Parent report measure of social emotional function | 2 years adjusted | |
Secondary | Parent Child Early Relational Assessment (PCERA) | Standardized observational assessment of parent-child interaction | 2 years adjusted | |
Secondary | State Trait Anxiety Inventory | Self report measure of anxiety | Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age | |
Secondary | Life Stress Subscale of the Parenting Stress Index (PSI) | Self report measure of stress | Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age | |
Secondary | Edinburgh Postnatal Depression Scale (EPDS) | Self report measure of maternal postpartum depression | Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age | |
Secondary | aEEG Burdjalov Score | The Olympic Brainz Monitor (OBM) Monitor (TMNatus), which provides continuous cerebral function monitoring, will be used for aEEG recordings at four time points. After a minimum baseline aEEG tracing of 4 hours, a sensory intervention (that has no movement artifact) will be performed for one hour, followed by monitoring for one additional hour after the sensory intervention is removed. This will be a total monitoring time of 6 hours. We will record who performed the intervention (parent, volunteer, research member) and the type of intervention (ie. holding, kangaroo, reading). Scores will also be evaluated as an outcome measure across PMA | within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours |
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