Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03230032
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2017-06-22
Brief Title:
Pacifier Activated Device and Mothers Voice in Infants at High-risk for Cerebral Palsy
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
RCT of Feeding Intervention With Pacifier Activated Device and Mothers Voice in Infants at High-risk for Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 mothers 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
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 mothers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None