Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-01-13 @ 12:37 PM
Study NCT ID:
NCT00847028
Status:
UNKNOWN
Last Update Posted:
2009-02-19
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
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': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain after venipuncture measured by the Leuven pain scale for newborns', 'timeFrame': 'solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring'}], 'secondaryOutcomes': [{'measure': 'difference in heart rhythm', 'timeFrame': 'heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Newborn', 'Pain', 'glucose solution', 'venipuncture', 'non-pharmacologic pain relief.'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn.', 'detailedDescription': 'This double-blind clinical trial is conducted on a maternity and newborn (N\\*) ward. Each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. The pain from the skin puncture will be scored using a validated pain scale (the "Leuven" pain scale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Neonates were included if they had to undergo a venipuncture as part of routine medical care.\n\nExclusion criteria\n\n* Unstable neonates with respiratory support as well as neonates with a proven neurological abnormality were excluded.\n* Newborns who had been administered sedatives, analgesics or naloxone during the past 48 hours were excluded along with premature infants younger than 32 weeks post menstrual age.'}, 'identificationModule': {'nctId': 'NCT00847028', 'briefTitle': 'Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial', 'orgStudyIdInfo': {'id': 'HHmol-001'}, 'secondaryIdInfos': [{'id': '(EC NR 7/37/203).'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'glucose 10%', 'interventionNames': ['Other: glucose 10%']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'glucose 20%', 'interventionNames': ['Other: 20% glucose']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'glucose 30%', 'interventionNames': ['Other: glucose 30%']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'placebo: sterile water', 'interventionNames': ['Other: sterile water']}], 'interventions': [{'name': 'glucose 10%', 'type': 'OTHER', 'description': '2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally', 'armGroupLabels': ['1']}, {'name': '20% glucose', 'type': 'OTHER', 'description': '2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally', 'armGroupLabels': ['2']}, {'name': 'glucose 30%', 'type': 'OTHER', 'description': '2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally', 'armGroupLabels': ['3']}, {'name': 'sterile water', 'type': 'OTHER', 'description': '2 minutes prior to the venipuncture, sterile water was administered orally', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Mol', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'H Hart ziekenhuis', 'geoPoint': {'lat': 51.19188, 'lon': 5.11662}}], 'overallOfficials': [{'name': 'Ben Dilen, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen + Heilig Hart ziekenhuis Mol'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Monique M. Elseviers', 'oldOrganization': 'Nusing Sciences, University of Antwerp'}}}}