Status:
COMPLETED
Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Cerebral Palsy Alliance
Conditions:
Infant Development
Infant,Premature
Eligibility:
All Genders
32-12 years
Phase:
NA
Brief 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 ...
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 neuro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03230032
Start Date
June 9 2017
End Date
July 31 2021
Last Update
September 13 2023
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205