Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants.

BACKGROUND: Premature infants are at risk for abnormal sensory development due to brain immaturity at birth and atypical early sensory experiences in the Neonatal Intensive Care Unit. This altered sensory development can have downstream effects on other more complex developmental processes. There are currently no interventions that address rehabilitation of sensory function in the neonatal period. METHODS: This study is a randomized controlled trial of preterm infants enrolled at 32-36 weeks postmenstrual age to either standard care or standard care plus multisensory intervention in order to study the effect of multisensory intervention as compared to standard care alone. The study population will consist of 100 preterm infants in each group (total n = 200). Both groups will receive standard care, consisting of non-contingent recorded parent's voice and skin-to-skin by parent. The multisensory group will also receive contemporaneous holding and light pressure containment for tactile stimulation, playing of the mother's voice contingent on the infant's pacifier sucking for auditory stimulation, exposure to a parent-scented cloth for olfactory stimulation, and exposure to carefully regulated therapist breathing that is mindful and responsive to the child's condition for vestibular stimulation. The primary outcome is a brain-based measure of multisensory processing, measured using time locked-EEG. Secondary outcomes include sensory adaptation, tactile processing, speech sound differentiation, motor and language function, measured at one and two years corrected gestational age. DISCUSSION: This is the first randomized controlled trial of a multisensory intervention using brain-based measurements in order to explain the causal effects of the multisensory intervention on neural processing changes to mediate neurodevelopmental outcomes in former preterm infants. In addition to contributing a critical link in our understanding of these processes, the protocolized multisensory intervention in this study is therapist administered, parent supported and leverages simple technology. Thus, this multisensory intervention has the potential to be widely implemented in various NICU settings, with the opportunity to potentially improve neurodevelopment of premature infants. TRIAL REGISTRATION: NIH Clinical Trials ( clinicaltrials.gov ): NCT03232931 . Registered July 2017.

A randomised controlled trial of protocolised music therapy demonstrates developmental milestone acquisition in hospitalised infants.

AIM: To compare the effectiveness of an intensive-intermittent vs. standard spaced protocolised music therapy intervention on supporting developmental milestone acquisition of infants >44 weeks postmenstrual age (PMA) hospitalised in a Neonatal Intensive Care Unit (NICU). METHOD: This was a comparative effectiveness study of infants 44-66 weeks PMA with a projected NICU stay of at least one month from recruitment. Infants were randomised to one of two treatment groups: traditional therapy (2x/week) and intermittent-intensive (4x/week, off, 4x/week, off). Both groups received the same number of sessions over a 4-week period. Sessions at the start and end of the treatment period were video recorded. Two masked researchers reviewed and coded videos. Milestones used for video recording were adapted from the Developmental Assessment of Young Children. RESULTS: Twenty-four infants participated, with groups matched for birth age, PMA at start of study, race, IVH severity, and respiratory support. Total and motor composite scores were higher post-intervention (Cohen's d = 0.71 and 0.97, both p < 0.01), with the same degree of skill acquisition found for both intervention groups. CONCLUSION: A developmental music therapy protocol supports developmental skills acquisition of post-term infants in a NICU. Similar outcomes for both groups provide therapists with varying treatment dosing options to best support their patients.

Vibration-based mitigation of noxious-evoked responses to skin puncture in neonates and infants: a randomised controlled trial.

OBJECTIVE: To assess the effect of a non-noxious vibratory stimulus on noxious-evoked cortical responses to skin puncture and to determine whether the presence of certain behavioural components may be used to predict such cortical responses. DESIGN: Randomised controlled trial. SETTING: Level IV neonatal intensive care unit at a stand-alone children's hospital. PATIENTS: 134 hospitalised infants between 36 and 52 weeks' postmenstrual age and ordered to receive a clinically required laboratory draw. INTERVENTIONS: Infants randomised to receive the intervention, a vibratory stimulus at the site of skin puncture beginning 10 s prior to a heel stick, or the control, no vibration. MAIN OUTCOME MEASURES: Electroencephalography and video recording time-locked to the deployment of the lancet for the skin puncture. Noxious-evoked cortical responses were measured by the area under the curve in the somatosensory region contralateral to the skin puncture. Behavioural responses were coded through video analysis. RESULTS: Noxious-evoked cortical responses were significantly reduced in participants receiving the vibratory stimulus compared with the control (frontal, p<0.0001; central, p=0.0088; central-parietal, p=0.0111). There were no significant differences in behavioural responses between groups (all p>0.05). CONCLUSIONS: A non-noxious vibratory stimulus presented prior to and continuing simultaneously with skin puncture significantly mitigates nociception in hospitalised infants. The presence or absence of facial expression components is inadequate to reliably predict pain signalling in the brain. TRIAL REGISTRATION NUMBER: NCT04050384.

Contingent Mother's Voice Intervention Targeting Feeding in Hospitalized Infants with Critical Congenital Heart Defects.

Infants with critical congenital heart defects (CCHD) are at high risk for feeding challenges and neurodevelopmental delays; however, few interventions promoting the neurodevelopmental progression of feeding have been studied with this population. Contingent mother's voice has been successfully used as positive reinforcement for non-nutritive suck (NNS) in studies with preterm infants, leading to improved weight gain and more rapid cessation of tube feedings; however, this type of intervention has not been studied in infants with CCHD. This study aimed to determine whether an NNS-training protocol using the mother's voice as positive reinforcement and validated in preterm infants could improve oral feeding outcomes in hospitalized infants with CCHD undergoing cardiac surgical procedures. Infants were randomized to receive the contingent mother's voice intervention before or after cardiac surgery, with a control comparison group receiving passive exposure to the mother's voice after surgery. There were no significant differences in discharge weight, PO intake, length of stay, time to full feeds, or feeding status at 1-month post-discharge between infants who received contingent mother's voice compared to those who did not. There were significant differences in PO intake and time to full feeds following surgery based on infants' pre-enrollment PO status and severity of illness. At 1-month post-discharge, parents of infants in the intervention group expressed a higher rate of positive feelings and fewer concerns regarding their infant's feeding compared to parents of infants in the control group. While the current protocol of 5 sessions was not associated with improved feeding outcomes in infants with CCHD, it empowered parents to contribute to their infant's care and demonstrated the feasibility of using the mother's voice as positive reinforcement for infants with CCHD. Further study of timing, intensity, and duration of interventions leveraging the mother's voice in this population is needed. ClinicalTrials.gov Identifier: NCT03035552.

Standardized music therapy with and without acclimatization, to improve EEG data acquisition in young children with and without disability.

INTRODUCTION: In young children, EEG data acquisition during stimulation tasks is difficult due to anxiety, movement and behaviorally-related interruptions, especially in those with disabilities. NEW METHOD: We used standardized music therapy (MT) protocols with and without acclimatization, during and prior to time-locked EEG with a published tactile testing protocol. Our prospective study leveraged a larger trial in children with/without cerebral palsy aged 7-27 months. Group1 received no preparation, Group2 received 15-minute MT prior to the EEG session, Group3 received the same as Group2 plus a rubber cap for home practice. All groups received MT procedural support during the EEG session. Sessions were stopped/started to acquire a full dataset. Trials were reviewed using a two-step artifact detection strategy by specialists masked to group allocation. RESULTS: 64 patients were included, 20 each in Groups 2 and 3, and 24 in Group1. Average age was 16.08 ± 6.33 months. All (100%) of children had data of sufficient quality and quantity for outcomes measurement without a second testing visit. There were no differences in useable trials by procedural group, disability status, age or stimulus condition. EEG recording time was shorter in Group3 vs. 1 (p = 0.02) and more patients in Group1 required repeat trials compared to Groups2 and 3 (p = 0.04 for both). COMPARISON WITH OLD METHOD: Our new methods resulted in no attrition from data loss, an improvement compared to published similar studies with data loss 30-55%. Acclimatization had minimal effects. CONCLUSION: In children under 3, MT protocols result in high rates of EEG data acquisition, decrease behaviorally-related interruptions and session acquisition time. This method is successful for typically developing children and those with cerebral palsy.