Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-29 @ 6:08 PM
Study NCT ID:
NCT02007759
Status:
TERMINATED
Last Update Posted:
2017-07-18
First Post:
2013-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Difficulty with recruiting patients; poor quality of EMG', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2013-10-14', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.', 'timeFrame': 'Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks'}, {'measure': "Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.", 'timeFrame': 'Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks'}, {'measure': 'Increase the amount of formula volume taken at feedings from beginning to end of study.', 'timeFrame': '2 weeks'}, {'measure': 'Earlier NG tube removal for the treatment group compared to the control group.', 'timeFrame': 'Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.', 'timeFrame': '2 weeks'}, {'measure': 'Decrease spells with oral feeds over the course of the study.', 'timeFrame': '2 weeks'}, {'measure': 'Allow for healthy weight gain via improved feedings.', 'timeFrame': '2 weeks'}, {'measure': 'Increase the caloric intake orally.', 'timeFrame': '2 weeks'}, {'measure': 'Decrease the oxygen requirement before and after study.', 'timeFrame': '2 weeks'}, {'measure': 'Decrease inpatient length of stay.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dysphagia', 'neuromuscular electrical stimulation', 'NMES', 'Neonates', 'Vitalstim'], 'conditions': ['Dysphagia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation (NMES) will provide a more efficient method of treating neonates with dysfunctional oral feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG) and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '36 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female.\n* Meet diagnostic criteria for dysphagia symptoms using the NOMAS and a VFSS.\n* Infants with intraventricular hemorrhage (IVH) and hypoxic events can be included.\n* Infants taking less than 5-10% of target volume by mouth between the ages of 36-42 weeks PCA.\n* Multiple swallows to clear bolus following suck that includes a desaturation \\<80% and bradycardia \\<80 bpm.\n* Apnea spells during feeds.\n* Aspiration or penetration by VFSS\n\nExclusion Criteria:\n\n* Known neurologic or neurodegenerative disorders.\n* Chromosomal anomalies and syndromes.\n* Cleft lip or palate.\n* Birth defects.\n* Unresolved cutaneous rash at the area of electrode placement.\n* Medical condition that is a contraindication to NMES.'}, 'identificationModule': {'nctId': 'NCT02007759', 'briefTitle': 'Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Sanford Health'}, 'officialTitle': 'Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates', 'orgStudyIdInfo': {'id': 'SH NMES for Dysphagia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VitalStim', 'description': 'This group will be assigned to the active VitalStim unit.', 'interventionNames': ['Device: VitalStim']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham VitalStim', 'description': 'This group will be assigned to the sham VitalStim unit.', 'interventionNames': ['Device: Sham VitalStim']}], 'interventions': [{'name': 'VitalStim', 'type': 'DEVICE', 'description': 'This group will receive active VitalStim treatment.', 'armGroupLabels': ['VitalStim']}, {'name': 'Sham VitalStim', 'type': 'DEVICE', 'description': 'This group will receive a sham VitalStim intervention.', 'armGroupLabels': ['Sham VitalStim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57117', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sanford USD Medical Center', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Akram Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanford Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanford Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}