Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04995393
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2021-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heel Warming Before Capillary Blood Sampling
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': 'D006361', 'term': 'Heating'}], 'ancestors': [{'id': 'D004780', 'term': 'Environment, Controlled'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Also masked: Biomedical Laboratory Scientist'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed of blood sampling', 'timeFrame': '10 minutes', 'description': 'µl blood/sec'}, {'measure': 'Duration of blood sampling', 'timeFrame': '10 minutes', 'description': 'Sec'}], 'secondaryOutcomes': [{'measure': 'Hemolysis index for potassium of the blood sample', 'timeFrame': '2 hours'}, {'measure': 'Degree of squeezing the infants foot during blood sampling', 'timeFrame': '1 minute', 'description': 'Scale 1 to 5'}, {'measure': 'Number of heel punctures required to obtain the blood sample', 'timeFrame': '10 minutes', 'description': '1, 2, 3 or 4'}, {'measure': 'ComfortNeo score of the infant during the blood sampling', 'timeFrame': '20 minutes', 'description': 'Pain assessment COMFORTneo score - range is 6 to 30.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Specimen Collection', 'Phlebotomy', 'Infant, Newborn', 'Heating', 'Heel', 'Pain'], 'conditions': ['Blood Specimen Collection']}, 'referencesModule': {'references': [{'pmid': '24866853', 'type': 'BACKGROUND', 'citation': 'Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114.'}, {'pmid': '11177093', 'type': 'BACKGROUND', 'citation': 'Anand KJ; International Evidence-Based Group for Neonatal Pain. Consensus statement for the prevention and management of pain in the newborn. Arch Pediatr Adolesc Med. 2001 Feb;155(2):173-80. doi: 10.1001/archpedi.155.2.173.'}, {'pmid': '21177753', 'type': 'BACKGROUND', 'citation': 'Losacco V, Cuttini M, Greisen G, Haumont D, Pallas-Alonso CR, Pierrat V, Warren I, Smit BJ, Westrup B, Sizun J; ESF Network. Heel blood sampling in European neonatal intensive care units: compliance with pain management guidelines. Arch Dis Child Fetal Neonatal Ed. 2011 Jan;96(1):F65-8. doi: 10.1136/adc.2010.186429.'}, {'pmid': '11896522', 'type': 'BACKGROUND', 'citation': 'Janes M, Pinelli J, Landry S, Downey S, Paes B. Comparison of capillary blood sampling using an automated incision device with and without warming the heel. J Perinatol. 2002 Mar;22(2):154-8. doi: 10.1038/sj.jp.7210583.'}, {'pmid': '30993840', 'type': 'BACKGROUND', 'citation': 'Aydin D, Inal S. Effects of breastfeeding and heel warming on pain levels during heel stick in neonates. Int J Nurs Pract. 2019 Jun;25(3):e12734. doi: 10.1111/ijn.12734. Epub 2019 Apr 17.'}, {'pmid': '23741774', 'type': 'BACKGROUND', 'citation': 'WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138650/'}, {'pmid': '16244215', 'type': 'BACKGROUND', 'citation': 'Hassan Z, Shah M. Scald injury from the Guthrie test: should the heel be warmed? Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F533-4. doi: 10.1136/adc.2005.072678.'}, {'pmid': '24476226', 'type': 'BACKGROUND', 'citation': 'Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.'}, {'pmid': '17700190', 'type': 'BACKGROUND', 'citation': 'Folk LA. Guide to capillary heelstick blood sampling in infants. Adv Neonatal Care. 2007 Aug;7(4):171-8. doi: 10.1097/01.ANC.0000286333.67928.04.'}, {'pmid': '28431226', 'type': 'BACKGROUND', 'citation': 'Sorrentino G, Fumagalli M, Milani S, Cortinovis I, Zorz A, Cavallaro G, Mosca F, Plevani L. The impact of automatic devices for capillary blood collection on efficiency and pain response in newborns: A randomized controlled trial. Int J Nurs Stud. 2017 Jul;72:24-29. doi: 10.1016/j.ijnurstu.2017.04.001. Epub 2017 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'Capillary blood sampling from the heel is often used in the treatment of infants admitted to neonatal intensive care (NICU). In Danish NICUs a heated blanket, a heated gel pad or a disposable glove with warm water are the methods most often used.\n\nThe purpose of this randomized controlled study is to investigate which of the mentioned heating methods ensures the best quality of the blood sample and provides the most gentle blood sampling for the infant.', 'detailedDescription': "Some infants experience a difficult and painful blood sampling which can lead to bruised or swollen heels and a blood sample of poor quality. To minimize the risk of that, the infant's heel is heated before the procedure as described in standard GP42-A6 from The Clinical and Laboratory Standards Institute. However, no consensus exists on which heating method to use. The aim of this study is to compare three different heating methods in terms of which method can help reduce pain experienced by infants as well as increase the quality of the blood samples.\n\nInfants (postmenstrual age ≥ 28 + 0) admitted to the NICU, Kolding Hospital and having a blood sample taken by a Biomedical Laboratory Scientist are invited to participate. A parental informed concent must be signed by both parents before participation.\n\nInfants are randomized to one of the three heating methods: glove, blanket or gel pad.\n\nThe following blood sampling procedure is closely monitored to register data corresponding to the five outcome measures.\n\nFurthermore the infants personal data, location of the infant during the procedure, surface temperature of the heel before and after heating, volume of sampled blood, sign of bruises and swelling as well as hematocrit are registered.\n\nData registration, web-based block randomization, data storage and statistical analysis are supported by OPEN (Open Patient data Explorative Network, University of Southern Denmark).\n\nThe study is registered as public research at the Region of Southern Denmark (journal no. 20/1316) and is approved by The Regional Committees on Health Research Ethics for Southern Denmark (ID S-20200082)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '77 Days', 'minimumAge': '2 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PMA (postmenstrual age) ≥ 28+0\n* Blood sampling performed by a Biomedical Laboratory Scientist\n\nExclusion Criteria:\n\n* GA (gestational age) ≥ 44+0\n* Weight \\> 6000 g\n* Coagulation related disorder\n* Severe illness/disorder\n* Heel is bruised or swollen\n* Parents not understanding written Danish language'}, 'identificationModule': {'nctId': 'NCT04995393', 'briefTitle': 'Heel Warming Before Capillary Blood Sampling', 'organization': {'class': 'OTHER', 'fullName': 'Kolding Sygehus'}, 'officialTitle': 'Standardization of Infants Heel Warming Before Capillary Blood Sampling - a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'S-20200082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glove', 'description': 'A heated glove containing water.', 'interventionNames': ['Procedure: Heating with a disposable glove containing water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blanket', 'description': 'A heated blanket.', 'interventionNames': ['Procedure: Heating with a blanket']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gel pack', 'description': 'A heated gel pack.', 'interventionNames': ['Procedure: Heating with a gel pack']}], 'interventions': [{'name': 'Heating with a disposable glove containing water', 'type': 'PROCEDURE', 'description': 'Heating of the infants heel with a glove before blood sampling.', 'armGroupLabels': ['Glove']}, {'name': 'Heating with a blanket', 'type': 'PROCEDURE', 'description': 'Heating of the infants heel with a blanket before blood sampling.', 'armGroupLabels': ['Blanket']}, {'name': 'Heating with a gel pack', 'type': 'PROCEDURE', 'description': 'Heating of the infants heel with a gel pack before blood sampling.', 'armGroupLabels': ['Gel pack']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Kolding', 'state': 'Region Southern Denmark', 'country': 'Denmark', 'facility': 'Neonatal intensive care (NICU), Lillebaelt Hospital, University Hospital of Southern Denmark', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}], 'overallOfficials': [{'name': 'Jonna Skov Madsen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark'}, {'name': 'Patricia Diana Soerensen', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark'}, {'name': 'Ulla List Toennesen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kolding Sygehus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Development and Innovation Fund at Lillebaelt Hospital', 'class': 'UNKNOWN'}, {'name': 'The Research Council for Sygehus Lillebælt', 'class': 'UNKNOWN'}, {'name': 'Sygekassernes Helsefond', 'class': 'OTHER'}, {'name': 'The Biomedical Laboratory Scientist Education and Research Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}