Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-14 @ 4:06 AM
Study NCT ID:
NCT03252327
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2017-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2017-08-08', 'studyFirstSubmitQcDate': '2017-08-14', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Preterm infants' pain", 'timeFrame': '20-30 minutes (during peripheral venous puncture procedures)', 'description': 'Premature Infant Pain Profile-Revised (PIPP-R) for pain, A score \\<7 suggests no or little pain, 7-12 mild to moderate pain and scores \\>12 indicate moderate to severe pain.'}], 'secondaryOutcomes': [{'measure': "preterm infants' physiological parameters:heart rate", 'timeFrame': '20-30 minutes (during peripheral venous puncture procedures)', 'description': 'Heart rate will be recorded from ECG leads. Heart rate in beats per minute (mean of physiological parameters)'}, {'measure': "Preterm infants' physiological parameters:respiration rate", 'timeFrame': '20-30 minutes (during peripheral venous puncture procedures)', 'description': 'Respiration rate will be recorded from ECG leads. Respiration rate in breaths per minute. (mean of physiological parameters)'}, {'measure': "Preterm infants' physiological parameters: oxygen saturation", 'timeFrame': '20-30 minutes (during peripheral venous puncture procedures)', 'description': 'Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters)'}, {'measure': "preterm infants' behavioral responses", 'timeFrame': '20-30 minutes (during peripheral venous puncture procedures)', 'description': 'The infant behavioral responses will be measured by using an infant behavioral coding scheme. Behavioral data during venous puncture procedures will be collected using a real-time colour video recorder. Frequency ratios for pain and distress behaviors, include: facial activity (e.g. brow bulge, eye squeeze, nasolabial furrow), body movement, cry, transition between sleep and wake states.'}, {'measure': "preterm infants' duration of fussing and cry", 'timeFrame': '20-30 minutes (during peripheral venous puncture procedures)', 'description': 'Fussing and crying will be record from the recording pen in minutes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Infants', 'Pain']}, 'descriptionModule': {'briefSummary': "Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '3 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age (GA) 28-37 weeks\n* Post-menstrual age (PMA) 29-38 weeks\n* Postnatal age 3-28 days\n* Sable condition (NTISSscore ≦ 22)\n* Apgar scores≧7 at 5 minutes after birth\n\nExclusion Criteria:\n\n* Neurologic impairment\n* Congenital anomalies\n* Surgery\n* Severe growth restriction at birth\n* Severe medical conditions requiring treatments'}, 'identificationModule': {'nctId': 'NCT03252327', 'briefTitle': "Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes", 'organization': {'class': 'OTHER', 'fullName': 'National Defense Medical Center, Taiwan'}, 'officialTitle': 'Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures', 'orgStudyIdInfo': {'id': '2-106-05-080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'routine care', 'description': 'Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care'}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Sensory Integrations(1)', 'description': 'The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).', 'interventionNames': ['Other: Multiple Sensory Integrations']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Sensory Integrations(2)', 'description': 'The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).', 'interventionNames': ['Other: Multiple Sensory Integrations']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Sensory Integrations(3)', 'description': 'The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).', 'interventionNames': ['Other: Multiple Sensory Integrations']}], 'interventions': [{'name': 'Multiple Sensory Integrations', 'type': 'OTHER', 'description': 'breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.', 'armGroupLabels': ['Multiple Sensory Integrations(1)', 'Multiple Sensory Integrations(2)', 'Multiple Sensory Integrations(3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Defense Medical Center, Taiwan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hsiang-Ping Wu', 'investigatorAffiliation': 'National Defense Medical Center, Taiwan'}}}}