At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
In Brief
A clinical study evaluating Therapist skin-to-skin Care, Contingent parent's voice exposure, and 2 other interventions for Preterm Infant. Completed, enrolled 248 participants across 3 sites.
Detailed Summary
Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth. This study uses rigorous scientific methods to measure the effects and determine the mechanisms of action of a parent-supported multisensory neurorehabilitative intervention for preterm infants, adaptable to a wide variety of neonatal environments, even when parents cannot be at their child's bedside. The intervention aims to improve brain multisensory processing, reactions to sensory stimulation in the home and long term language and motor development.
Study Details
Timeline
Interventions
Skin-to-skin (STS) holding is part of the multisensory intervention where the therapist will wear a clean 100% cotton T-shirt with a clean hospital gown on top of the shirt and wrap the "kangaroo" positioner securely over the gown. A gauze square scented with parent's skin will be used to provide olfactory stimulation. Therapist STS sessions occur with simultaneous playing of mother's voice contingent on infant pacifier sucking.
The parent's voice recording is delivered via a pacifier-activated music player (PAM). The Pacifier Activated Lullaby® (PAL®) device, is a digital music delivery system that integrates a sensor, a pacifier routinely used in the NICU, and a receiver. It delivers a predetermined 10 seconds of recorded parent's voice singing lullabies upon detection of a suck that meets a preset pressure threshold. The original systems were modified for research use by decreasing the lower limit of activation thresholds for delivering the recording. Minimal effort is required to trigger the device. However, the settings ensure that regular attempts are needed to continue to receive continual presentation of the recording of mother's voice by requiring another suck after 10 seconds. The auditory stimulation with PAL will be provided when the infants are still awake (i.e., at the beginning of the session).
The standard of care includes parental skin-to-skin care and exposure to parent's voice. During parental skin-to-skin care, infants are placed in a prone position with head positioned over the sternum, allowing transmission of breath and heart sounds to the developing ear. Deeper pressure is applied to offer support and feedback to the child's bottom. Session length is set to a minimum of 45 minutes per unit protocols.
Per standard of care, preterm infants in the NICU currently receive noncontingent recorded parents' voice during two 20 minute sessions per day. Recordings are standardized and are played through a sterilizable device (DINO-egg).