Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00414258
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2006-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Holding Study: Feeding Analgesia in Preterm Infants
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007774', 'term': 'Lactation'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D049590', 'term': 'Postpartum Period'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-12', 'studyFirstSubmitDate': '2006-12-19', 'studyFirstSubmitQcDate': '2006-12-20', 'lastUpdatePostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate'}], 'secondaryOutcomes': [{'measure': 'Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States'}, {'measure': 'Samples taken at baseline and recovery;Salivary Cortisol sample'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain Response'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure\n\nHypothesis:\n\n1. When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.\n2. Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.", 'detailedDescription': 'Research Method:\n\nIn a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born between 30-35 weeks gestational age\n* Mother has fluent English\n\nExclusion Criteria:\n\n* CNS injury\n* congenital anomaly\n* active infection\n* has had no surgeries or analgesics/sedatives in last 72 hours\n* history of maternal drug exposure'}, 'identificationModule': {'nctId': 'NCT00414258', 'briefTitle': 'The Holding Study: Feeding Analgesia in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Holding Pilot Study: Feeding Analgesia in Preterm Infants', 'orgStudyIdInfo': {'id': 'C06 - 0347'}}, 'armsInterventionsModule': {'interventions': [{'name': 'breastfeeding', 'type': 'PROCEDURE', 'description': 'See detailed description.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Children's and Women's Health Centre of British Columbia, Special Care Nursery", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Liisa Holsti, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Liisa Holsti', 'oldOrganization': 'University of British Columbia'}}}}