Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
Condition: Infant Development; Infant,Premature; Hydrocephalus; Neonatal Encephalopathy; Infarction; PVL; Thrombosis; Intraventricular Hemorrhage
MeSH terms: Cerebral Palsy; Brain Diseases; Hydrocephalus; Thrombosis; Infarction; Hemorrhage
Study type: Interventional

Summary: 
      The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a
      pacifier-activated device (PAM) with mothers' voice to condition suck-strength and
      rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for
      CP.
    

Detailed description: 
      Poor neuromotor and sensory function of the aerodigestive system in children with CP often
      originates in the neonatal period, when they are still classified as "high-risk for CP".
      Characteristic neuroimaging abnormalities including severe intraventricular (IVH)
      hydrocephalus and periventricular leukomalacia (PVL), stroke or ischemia with lesions affect
      the posterior limb of the internal capsule are strong Indicators of high-risk for CP,
      especially when combined with abnormal General Movements Assessment (Guidelines for Early
      Detection of CP; Stockholm, 2016). Early intervention, when plasticity is greatest has the
      largest impact on functional recovery in CP. While intervening in infancy involves treating
      some infants who will not develop CP, the goal is to establish new neuronal connections and
      functional patterns before less efficient adaptations can occur. However, no current
      interventions target the oral-motor dysfunction of infants at high-risk for CP, before their
      discharge from the NICU.

      Evidence for behavioral interventions in feeding disorders for children with CP ranges from
      insufficient to moderate, with a clear need for rigorous studies. In healthy preterm and
      late-preterm infants, oromotor practice opportunities such as non-nutritive suck (NNS) are
      safe and promote effective suck-swallow-breathe patterns, with decreased time to achieving
      oral feeds. While NNS opportunities are frequent in most NICUs, they must be adapted for
      effectiveness in infants at high-risk for CP. Motor learning in these infants must
      incorporate repetitive, self-initiated and task-directed activities. Learning is optimized
      when contingent on feedback, such as positive reinforcement.

      NNS training (rather than simple exposure) has been implemented successfully using rhythmic
      sound of mother's voice singing contingent upon suck strength and pattern, as detected by a
      pacifier-sensor device (Pacifier-activated music; PAM) in an cohort of predominantly healthy
      preterm infants. An RCT demonstrated that NNS-trained infants had feeding tubes removed one
      week earlier than controls, with fewer aspiration events and feeding difficulties in infancy.
      The intervention was promising in the dozen infants with significant neural injury. Following
      this preliminary data, this study seeks to further determining the efficacy of non-nutritive
      suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition
      suck-strength and rhythmicity, in improving the feeding and developmental outcomes of infants
      at high-risk for CP.
    

Intervention name(s): pacifier-activated device
Intervention type(s): Device
Intervention description(s): The utilization of the pacifier-activated-music player combines the sound of the mother's voice with a pacifier routinely used with each patient during their inpatient NICU stay
Other intervention name(s): PAL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There participants will be randomized to two groups: PAL (pacifier and mother's voice provided contingently on sucking behavior) or Sounds of Love (listening to mother's voice not contingent upon sucking behavior on the pacifier, but pacifier available, per standard of care). To allow for high repetitiveness of the treatment, participants in both groups will receive 2 daily 15-min sessions of the intervention or control treatments for a total of 20 sessions. Sessions occur 15-30 min prior to feeding.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention