The MIND Randomized Controlled Trial: An Intervention to Improve Neural Speech Processing and 2-Year Language Outcomes of Infants Born Preterm.

OBJECTIVES

To assess whether contingently administered caregivers' infant-directed voice in a multisensory intervention would have a larger effect than standard care on preterm neural speech-sound differentiation and to determine if effects of the intervention causally mediated differences in 2-year language outcomes.

STUDY

DESIGN

A randomized controlled trial of the MIND (Multisensory support to Improve Neural processing and Development) intervention (contingent caregiver's recorded voice, scent cloth, holding by therapist in kangaroo binder; 20 sessions, 20 minutes each, over 2-3 weeks) compared with an enhanced standard care control (passive listening to recorded caregiver's voice, same dose) starting at 32-36 weeks of corrected gestational age (GA) among infants in the neonatal intensive care unit. Speech-sound differentiation was measured by auditory time-locked electroencephalogram (EEG) pre- and post-intervention and language outcomes using Bayley Scales of Infant and Toddler Development and Preschool Language Scales at 2 years. Analyses were conducted through ANCOVA and causal mediation modeling.

RESULTS

Of enrolled infants (mean GA 28.8 weeks), 100 completed MIND and 98 completed enhanced standard care, with usable EEG data pre- and post-intervention. Infants receiving MIND had greater neural speech-sound differentiation compared with controls (F ranging 5.33-7.87; P ranging .03 to .04). MIND effects included small-to-medium size effects on language outcomes that were mediated by EEG with total effects model R2 ranging 0.39-0.57 (P ranging .05 to <.001), all adjusting for GA and maternal education.

CONCLUSIONS

MIND, a parent-supported, therapist-implemented intervention, can improve preterm speech-sound differentiation in the neonatal intensive care unit and 2-year language outcomes. Efficacious parent-engaging neuropromotive interventions can change neurodevelopment, even without bedside presence.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03232931.