Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-27 @ 8:00 AM
Study NCT ID:
NCT06700135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensorimotor Stimulation on Oral Feeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-01-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transition time from tube to full oral feeding', 'timeFrame': '- At least one-time breast feeding in a 24-hour period (Fucile et al., 2013). - Consuming eight feedings per day for two consecutive days. - Capable of consuming orally over 80% of the recommended total fluid intake within a 24-hour period (Premji et', 'description': 'the number of days from the commencement of the intervention to the first day of exclusive oral feeding.'}, {'measure': 'Time taken to accomplish exclusive oral feeding', 'timeFrame': 'At least one-time breast feeding in a 24-hour period (Fucile et al., 2013). - Consuming eight feedings per day for two consecutive days. - Capable of consuming orally over 80% of the recommended total fluid intake within a 24-hour period (Premji et a', 'description': 'this is the number of days from the beginning of oral feeding until discharge.'}], 'secondaryOutcomes': [{'measure': 'Total hospital stay', 'timeFrame': 'At least one-time breast feeding in a 24-hour period (Fucile et al., 2013). - Consuming eight feedings per day for two consecutive days. - Capable of consuming orally over 80% of the recommended total fluid intake within a 24-hour period', 'description': 'this is the number of days from the start of the oral stimulation program until discharge from the NICU.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonates', 'Hypoxic ischemic encephalopathy', 'Sensorimotor stimulation'], 'conditions': ['Neonates Post Hypoxic Ischemic Encephalopathy']}, 'descriptionModule': {'briefSummary': 'Background: Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are significant causes of irreversible adverse neurodevelopmental outcomes in children. Neonates and infants with HIE commonly experience difficulties in learning the oromotor skills of sucking, swallowing, and breathing. These feeding problems can lead to severe complications such as weight loss, dehydration, malnutrition, and developmental deficits.\n\nObjective: The study aims to assess the efficacy of sensorimotor stimulation intervention on oral skills in neonates with post-hypoxic ischemic encephalopathy in the neonatal intensive care unit (NICU).\n\nMethods: The study will include thirty infants with hypoxic-ischemic encephalopathy. They will be divided into two equal groups: The study group receive traditional medical treatment as well as a sensorimotor stimulation program, whereas the control group receive only traditional medical treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '120 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neonates, diagnosed with post-hypoxic ischemic encephalopathy\n\nExclusion Criteria:\n\n* Neonates with congenital anomalies affecting the oral-facial area,\n* or syndromes associated with developmental delays,\n* chronic medical complications'}, 'identificationModule': {'nctId': 'NCT06700135', 'briefTitle': 'Sensorimotor Stimulation on Oral Feeding', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Sensorimotor Stimulation on Oral Feeding Skills for Neonates Post Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit', 'orgStudyIdInfo': {'id': 'sensorimotor stimuli'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'the control group, which comprised 15 neonates, received only traditional medical treatment.', 'interventionNames': ['Other: sensorimotor stimulation program sessions']}, {'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'The study group, consisting of 15 neonates, received traditional medical treatment along with sensorimotor stimulation program sessions. These sessions included oral stimulation protocol, Tactile/Kinesthetic (T/K) intervention, feeding position, and oral support.', 'interventionNames': ['Other: sensorimotor stimulation program sessions']}], 'interventions': [{'name': 'sensorimotor stimulation program sessions', 'type': 'OTHER', 'description': 'The study group, consisting of 15 neonates, received traditional medical treatment along with sensorimotor stimulation program sessions. These sessions included oral stimulation protocol, Tactile/Kinesthetic (T/K) intervention, feeding position, and oral support.', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed fekry Salman, PhD', 'role': 'CONTACT', 'email': 'a.salman@ammanu.edu.jo', 'phone': '+962797168340'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Ahmed fekry ibrahim salman', 'investigatorAffiliation': 'Al-Ahliyya Amman University'}}}}