Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants

NACompletedINTERVENTIONAL
Enrollment

248

Participants

Timeline

Start Date

October 29, 2018

Primary Completion Date

February 20, 2023

Study Completion Date

April 25, 2025

Conditions
Preterm Infant
Interventions
BEHAVIORAL

Therapist skin-to-skin Care

"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."

DEVICE

Contingent parent's voice exposure

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).

BEHAVIORAL

Parental skin-to-skin care

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.

DEVICE

Recorded parent's voice

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).

Trial Locations (3)

30303

Grady Memorial Hospital, Atlanta

30308

Emory University Hospital Midtown, Atlanta

43205

Nationwide Children's Hospital, Columbus

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Nationwide Children's Hospital

OTHER

lead

Emory University

OTHER

NCT03232931 - Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants | Biotech Hunter | Biotech Hunter