Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT03421158
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2018-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-pharmacological Analgesic Effects on Term Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007774', 'term': 'Lactation'}, {'id': 'D013395', 'term': 'Sucrose'}, {'id': 'D041361', 'term': 'Pacifiers'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D049590', 'term': 'Postpartum Period'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D015370', 'term': 'Infant Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions', 'timeFrame': '12 month', 'description': 'Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neonates', 'Non-pharmacological'], 'conditions': ['Pain', 'Breast Feeding']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.', 'detailedDescription': 'This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.\n\nA heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.\n\nThe average pain score from two research nurses were used for statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'minimumAge': '24 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational Age 38-40\n* 2.5-4.0kg\n* 24-48hours of age\n* Receiving heel lance procedure\n* Apgar\\>7 at birth\n* NPASS\\<3 at time of heel lance\n\nExclusion Criteria:\n\n* Prior heel lance procedure\n* birth trauma\n* forceps or vacuum delivery\n* maternal drug abuse during delivery'}, 'identificationModule': {'nctId': 'NCT03421158', 'briefTitle': 'Non-pharmacological Analgesic Effects on Term Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance', 'orgStudyIdInfo': {'id': '31216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Newborns received no pain interventions during the procedure'}, {'type': 'EXPERIMENTAL', 'label': 'Breastfeeding', 'description': 'Newborns were breastfed during the procedure', 'interventionNames': ['Behavioral: breastfeeding']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Sucrose', 'description': 'Newborns were given oral sucrose during the procedure', 'interventionNames': ['Dietary Supplement: oral sucrose']}, {'type': 'EXPERIMENTAL', 'label': 'Skin to skin contact', 'description': 'Newborns were placed in direct contact with their mothers during the procedure', 'interventionNames': ['Behavioral: Skin-to-Skin contact']}, {'type': 'EXPERIMENTAL', 'label': 'Non-nutritive sucking', 'description': 'Newborns were given a pacifier to suck on during the procedure', 'interventionNames': ['Behavioral: Non-nutritive sucking']}], 'interventions': [{'name': 'breastfeeding', 'type': 'BEHAVIORAL', 'description': 'Newborns were breastfed during the procedure', 'armGroupLabels': ['Breastfeeding']}, {'name': 'oral sucrose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Newborns were given oral sucrose during the procedure', 'armGroupLabels': ['Oral Sucrose']}, {'name': 'Skin-to-Skin contact', 'type': 'BEHAVIORAL', 'description': 'Newborns were placed in direct contact with their mothers during the procedure', 'armGroupLabels': ['Skin to skin contact']}, {'name': 'Non-nutritive sucking', 'type': 'BEHAVIORAL', 'otherNames': ['Pacifier'], 'description': 'newborns were given a pacifier to suck on during the procedure', 'armGroupLabels': ['Non-nutritive sucking']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jie Chang, BSN,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor, Pediatrics', 'investigatorFullName': 'Annette Nasr', 'investigatorAffiliation': 'Stanford University'}}}}