Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
Infant Development, Infant,Premature, Hydrocephalus
About this trial
This is an interventional prevention trial for Infant Development
Eligibility Criteria
Inclusion Criteria:
- PMA at enrollment >32 6/7 and <42 AND
- Diagnoses of Grade III/IV IVH, hydrocephalus or PVL, neonatal encephalopathy or thrombosis/infarct with involvement of the posterior limb of the internal capsule OR
- Abnormal GMA by certified study staff and masked gold-standard reading
Exclusion Criteria: Infants cannot be
- on assisted ventilation
- receiving more than 50% of their feeds orally averaged over the 72 hours prior to study start
- receiving less than 50% of their feeds enterally
- receiving enteral feed for greater than 60 min.
- considered medically unsafe to feed orally by the medical or feeding team as defined by unit/clinical protocol
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention Group
Control Group
Sessions will use a pacifier-activated device (PAL) system. The device sensor attaches to a routinely-used pacifier and measures timing and pressure of the sucks. If the infant reaches the preset suck pressure, he receives 10 seconds of mother's voice. The receiver/speaker box controls the volume to < 65dB on scale C. PAM will be set to the lowest settings for the first session. Using sensor measurements, the therapist will increase the threshold for number of sucks and strength once the infant produces three consecutive sucks above current level and continue per protocol.
Infants will receive 2 daily 15-min listening sessions of mother's voice recording, contiguous but not simultaneous with PAM NNS sessions without suck-contingent reinforcement (no voice).