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

Emory University

Status: Completed

Conditions: Preterm Infant

Treatments: Device: Contingent parent's voice exposure; Device: Recorded parent's voice; Behavioral: Therapist skin-to-skin Care; Behavioral: Parental skin-to-skin care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03232931

IRB17-00025/IRB18-00579

STUDY00003034

R01HD093706 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This study is a randomized controlled trial design with intent-to-treat analysis in hospitalized preterm infants between 32 and 36 weeks post-menstrual age. Both the control and intervention groups will receive routine neonatal intensive care unit care (i.e., skin-to-skin care by parent when available and daily sessions of exposure to recorded parent's voice). In addition to routine care, the parent-supported multisensory intervention consists of sessions of standardized, therapist-administered, auditory-tactile stimulation that combines contingent recorded mother's voice delivered using a pacifier-activated system, during holding with supportive tactile containment against the therapist's chest, covered by cloth imprinted with mother's scent. Possible covariates, multi- and uni-sensory processing, will be measured at entry into the study and immediately after the treatment phase. Event-related potential (ERP) testing will be performed prior to the prior to intervention and after intervention is complete, which occurs at 36 weeks postmenstrual age (PMA) on average. ERP testing will take approximately 30 to 40 minutes. All infants will be seen at the neonatal intensive care unit (NICU) Follow-Up Program clinics at 9-12 months PMA (Year 1) and 22-24 months PMA (Year 2), where neurodevelopmental outcomes will be assessed using standardized methods.

Parents will also have the opportunity to consent separately to a secondary part to the study in which their infant would participate in one additional ERP testing session in the NICU between 34-36 weeks PMA and one additional visit to the clinical laboratory for ERP testing between 3-4 months PMA. This optional, secondary part of the study is observational only and does not influence randomization for the main trial. For the secondary part of the study, the population will be 40 of the 230 participants. All parents who are approached for the study prospectively and are randomized to control group will be asked if they would like to participate in the secondary part. Enrollment for this secondary part of the study will stop when 40 participants are reached.

Enrollment: 248 patients

Sex: All

Ages: 32 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalization at a study location
• Postmenstrual age of 32 weeks 0 days gestation to 36 weeks 0 days gestation

Exclusion criteria

• Ventilation using an endotracheal tube
• Major congenital malformations
• Family history of genetic hearing loss
• Use of sedatives or seizure medications

Secondary Study Inclusion Criteria:

• Enrolled in the control group of the main study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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248 participants in 2 patient groups

Multisensory Intervention

Experimental group

Description:

Preterm infants in the NICU who are randomized to receive a multisensory intervention, in addition to the standard of care. The multisensory intervention uses recordings of the parents' voices and nurturing touch administered in the NICU during 12 to 23 sessions of standardized, therapist-administered, auditory-tactile stimulation, dispersed over a 2 to 3 week period. The intervention includes 2 components: (1) holding and light pressure containment of the infant against the hospital-gown covered chest of the therapist for tactile and non-specific auditory stimulation simultaneous with (2) playing of mother's voice contingent on infant pacifier sucking. Additionally, a gauze square scented with parent's skin will be used to provide olfactory stimulation.

Treatment:

Behavioral: Parental skin-to-skin care

Behavioral: Therapist skin-to-skin Care

Device: Recorded parent's voice

Device: Contingent parent's voice exposure

Standard of Care

Other group

Description:

Preterm infants in the NICU who are randomized to receive the standard of care. The standard care for preterm infants in the NICU currently follows medical protocols of skin-to-skin holding and exposure to recordings of parent's voice.

Treatment:

Behavioral: Parental skin-to-skin care

Device: Recorded parent's voice