Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03230032
Study type Interventional
Source Nationwide Children's Hospital
Contact
Status Completed
Phase N/A
Start date June 9, 2017
Completion date July 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Recruiting NCT04398628 - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed NCT05426564 - Exploratory Assessment of the Quantra® System in Adult ECMO Patients
Not yet recruiting NCT05830916 - Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02439190 - CV004-007 Thrombosis Chamber Study Phase 1
Completed NCT02526628 - Thrombosis and Neurocognition in Klinefelter Syndrome
Completed NCT02341638 - Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects Phase 1
Completed NCT01855516 - Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin N/A
Unknown status NCT00983112 - Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery Phase 4
Completed NCT00412464 - Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis Phase 1
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00346424 - Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters Phase 3
Terminated NCT00303420 - Alteplase for Blood Flow Restoration in Hemodialysis Catheters Phase 4
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Completed NCT00039858 - Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Phase 4
Completed NCT00007410 - Genetic Architecture of Plasma T-PA and PAI-1 N/A
Completed NCT00000538 - Dietary Effects on Lipoproteins and Thrombogenic Activity Phase 3
Completed NCT00005436 - Lupus Cohort--Thrombotic Events and Coronary Artery Disease N/A