Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 5:55 PM
Study NCT ID:
NCT03913533
Status:
WITHDRAWN
Last Update Posted:
2024-09-19
First Post:
2019-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001238', 'term': 'Asphyxia Neonatorum'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'the outcome assessed will be masked to group allocation'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funding obtained', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to obtain Heart rate', 'timeFrame': 'within the first 60 seconds form birth', 'description': 'Time to obtain Heart rate form birth'}], 'secondaryOutcomes': [{'measure': 'Accuracy of heart rate assessment using either technique', 'timeFrame': 'within the first 60 seconds form birth', 'description': 'Accuracy of heart rate assessment using tap-based application or 6-sec method'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Newborn', 'Heart rate assessment', 'Delivery Room'], 'conditions': ['Asphyxia Neonatorum', 'Birth Asphyxia']}, 'referencesModule': {'references': [{'pmid': '16188811', 'type': 'RESULT', 'citation': 'Saugstad OD, Ramji S, Rootwelt T, Vento M. Response to resuscitation of the newborn: early prognostic variables. Acta Paediatr. 2005 Jul;94(7):890-5. doi: 10.1111/j.1651-2227.2005.tb02007.x.'}, {'pmid': '26473001', 'type': 'RESULT', 'citation': 'Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.'}, {'pmid': '26874298', 'type': 'RESULT', 'citation': 'Duryea EL, Nelson DB, Wyckoff MH, Grant EN, Tao W, Sadana N, Chalak LF, McIntire DD, Leveno KJ. The impact of ambient operating room temperature on neonatal and maternal hypothermia and associated morbidities: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):505.e1-505.e7. doi: 10.1016/j.ajog.2016.01.190. Epub 2016 Feb 10.'}, {'pmid': '16989935', 'type': 'RESULT', 'citation': "Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006 Dec;71(3):319-21. doi: 10.1016/j.resuscitation.2006.04.015. Epub 2006 Sep 20."}, {'pmid': '18492509', 'type': 'RESULT', 'citation': "Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6."}, {'pmid': '11900034', 'type': 'RESULT', 'citation': 'Kopotic RJ, Lindner W. Assessing high-risk infants in the delivery room with pulse oximetry. Anesth Analg. 2002 Jan;94(1 Suppl):S31-6.'}, {'pmid': '30538976', 'type': 'RESULT', 'citation': "Luong DH, Cheung PY, O'Reilly M, Lee TF, Schmolzer GM. Electrocardiography vs. Auscultation to Assess Heart Rate During Cardiac Arrest With Pulseless Electrical Activity in Newborn Infants. Front Pediatr. 2018 Nov 27;6:366. doi: 10.3389/fped.2018.00366. eCollection 2018."}, {'pmid': '29895572', 'type': 'RESULT', 'citation': 'Patel S, Cheung PY, Solevag AL, Barrington KJ, Kamlin COF, Davis PG, Schmolzer GM. Pulseless electrical activity: a misdiagnosed entity during asphyxia in newborn infants? Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F215-F217. doi: 10.1136/archdischild-2018-314907. Epub 2018 Jun 12.'}, {'pmid': '15036740', 'type': 'RESULT', 'citation': 'Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002.'}, {'pmid': '20483522', 'type': 'RESULT', 'citation': 'Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18.'}, {'pmid': '30262463', 'type': 'RESULT', 'citation': 'Binotti M, Cavallin F, Ingrassia PL, Pejovic NJ, Monzani A, Genoni G, Trevisanuto D. Heart rate assessment using NeoTapAdvancedSupport: a simulation study. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F440-F442. doi: 10.1136/archdischild-2018-315408. Epub 2018 Sep 27.'}]}, 'descriptionModule': {'briefSummary': "Some newborn babies have difficulty breathing at birth and need help. When babies need help with breathing the clinical team, the team measures heart rate using a stethoscope to check its heart rate and figure out what kind of help they will need. If the heart rate is too low, the clinical team will begin to inflate the baby's lung. Knowing the baby's heart rate quickly is important but the stethoscope is inaccurate, and might delay start of resuscitation. Using a smartphone app that uses screen tapping with a stethoscope could allow heart rate to be measured much faster compared to the stethoscope and allow the clinical team to support the baby's needs better immediately after birth.", 'detailedDescription': "Purpose\n\nNearly 10% of all infants born worldwide require respiratory support at birth and birth asphyxia remains one of the leading causes of infant morbidity and mortality. Neonatal resuscitation is the most effective strategy to deal with this condition. Moreover, an infant's heart rate (HR) is the most significant clinical parameter used to assess the need for and response to neonatal resuscitation. Currently, a newborn's HR is determined by auscultating or palpating of the umbilical cord. Although auscultation is more precise compared to palpation, both methods are inaccurate and tend to underestimate HR. The current resuscitation guidelines also recommend using electrocardiogram (ECG) and pulse oximetry, which allow for continuous monitoring, however are slow to apply and detect HR compared to stethoscopes. During neonatal resuscitation, an infant's HR is necessary to initiate resuscitation and to monitor the effectiveness of each intervention and therefore it becomes essential to accurately and quickly assess an infant's HR during this process. If HR is detected slowly or inaccurately, there is an increased risk that necessary interventions are not started or that certain interventions are prolonged, which could lead to increased morbidity and mortality of the infants. The recent advances in technology, namely the development of a smartphone tap application for HR assessment is promising as a novel tool for quick and accurate HR detection during neonatal resuscitation.\n\nHypothesis\n\nThe use of a tap-based smartphone application will be faster and more accurate when compared to standard auscultation with the 6-sec method to assess HR.\n\nJustification\n\nSimulation studies have shown that it is feasible to measure HR using a tap-based application. Moreover, the investigator's group has recently shown its reliability in an animal model of asphyxia-induced neonatal swine. The investigator showed its accuracy compared to the experimental gold standard carotid blood flow-derived HR assessments and report a median time of 3 sec for assessment, which is less than the current recommended time for auscultation. However, no study has been performed in the delivery room in newborn babies at birth. Therefore, the investigator aim to compare the tap-based application to the current 6-sec standard approach to assess HR during neonatal resuscitation in the delivery room. Ehe investigator anticipate this study will allow us to determine the most reliable approach for initial assessment to reduce neonatal morbidity and mortality outcomes.\n\nObjectives\n\nTo examine (i) accuracy and (ii) speed to assess HR using auscultation with a tap-based application during neonatal resuscitation.\n\nResearch Method/Procedures\n\nThe proposed study is a randomized controlled trial comparing two different approaches to accurately assess HR. The investigator will compare the routinely used Neonatal Resuscitation Program 6-sec method with a stethoscope using two different methods of auscultation \\[6-sec method and tap-based method (NeoTapLS, Tap4Life, Stockholm, Sweden)\\] to accurately assess HR immediately after birth. The investigator aim to collect the data over a period of 12 months.\n\nTwo investigators in addition to the clinical team will attend the delivery of newborn infants. Immediately after birth the infant will be placed on a resuscitation trolley where a pulse oximeter will be attached to the right hand. At the same time three ECG leads will be placed on the infant's chest. Simultaneously the stethoscope will be placed by one of the investigators on the infants' chest to obtain the HR . In the alternative setup, stethoscope will be used in combination with the tap-based application.\n\nIn both setups, the time needed to display a HR will be recorded for all devices. All infants will have routine HR measured using ECG, which will be used as comparison for accuracy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All newborn infants delivered in the Royal Alexandra Hospital (RAH) 22+0-41+6 weeks gestation.\n\nExclusion Criteria:\n\n* Infants will be excluded if parents refused to consent to the study.'}, 'identificationModule': {'nctId': 'NCT03913533', 'briefTitle': 'Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Standard 6-sec Method Versus Tap-based Application Method to Assess Heart Rate at Birth - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Pro00089994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant.', 'interventionNames': ['Device: Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Heart rate assessment using Tap-based smartphone application At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed.', 'interventionNames': ['Device: Heart rate assessment using Tap-based smartphone application']}], 'interventions': [{'name': 'Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method', 'type': 'DEVICE', 'description': 'Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant.', 'armGroupLabels': ['Control group']}, {'name': 'Heart rate assessment using Tap-based smartphone application', 'type': 'DEVICE', 'description': 'At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Georg Schmolzer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'once study is completed and published', 'ipdSharing': 'YES', 'description': 'requests can be made to the PI', 'accessCriteria': 'email requests to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}