Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 5:31 PM
Study NCT ID:
NCT03854435
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Heart Rate in Infants Needing Resuscitation at Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019023', 'term': 'Stethoscopes'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2019-02-23', 'lastUpdatePostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of agreement of herat rate obtained by auscultation or palpation (HR: <60bpm/60-100bpm/>100bpm) obtained by auscultation or palpation compared with the HR as determined by ECG', 'timeFrame': '1 minute'}], 'secondaryOutcomes': [{'measure': 'Time of the first breath', 'timeFrame': '20 minutes'}, {'measure': 'Time of regular breathing', 'timeFrame': '20 minutes'}, {'measure': 'Mortality rate', 'timeFrame': '1 month (during hospitalization)'}, {'measure': 'Number (%) of asphyxiated neonates', 'timeFrame': '5 min'}, {'measure': 'Age at discharge/death (days)', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perinatal Asphyxia']}, 'referencesModule': {'references': [{'pmid': '32222255', 'type': 'DERIVED', 'citation': 'Cavallin F, Cori MS, Negash S, Azzimonti G, Vento G, Putoto G, Trevisanuto D. Heart Rate Determination in Newborns at Risk for Resuscitation in a Low-Resource Setting: A Randomized Controlled Trial. J Pediatr. 2020 Jun;221:88-92.e1. doi: 10.1016/j.jpeds.2020.02.026. Epub 2020 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'Algorithms for neonatal resuscitation adapted to low resource settings include HR evaluation by auscultation or umbilical cord palpation at about one minute of life.\n\nPrevious studies conducted in high resource settings showed that auscultation of the precordium is more accurate than umbilical palpation to assess HR of healthy infants at birth.The last versions of the American Heart Association and the European Resuscitation Council Guidelines on Neonatal resuscitation suggest that "during resuscitation of term and preterm newborns, the use of 3-lead ECG for the rapid and accurate measurement of the newborn\'s heart rate may be reasonable". However, this remains a weak recommendation with a very-low-quality evidence.\n\nIn low resource countries, a stethoscope is rarely available and palpation of the umbilical pulse is the method used for detecting HR. Although this is preferable to other palpation sites (i.e. femo-ral and brachial artery), there is a high likelihood of underestimating HR with palpation of the umbilical pulse in healthy infants.\n\nThe accuracy of assessing HR by auscultation and umbilical palpation in newborn infants requir-ing resuscitation remains unknown.\n\nTo the investigator\'s knowledge, there are not previous studies that have compared the accuracy of HR estima-tion by auscultation vs. umbilical palpation in newborn infants needing resuscitation This study was designed to compare two different methods (auscultation and umbilical cord pal-pation) of HR estimation in newborn infants needing resuscitation, in order to determine which method is most suitable for use in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'genderBased': True, 'genderDescription': 'Meles and females will be enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. inborn infants (and)\n2. need for resuscitation (and)\n3. parental consent; a written informed consent will be obtained by a member of the neonatal staff involved in the study from a parent or guardian at maternal admission to the obstetrical ward or prior to delivery.\n\nExclusion Criteria:\n\n1. Major congenital malformations;\n2. Parental refusal to participate to the study.'}, 'identificationModule': {'nctId': 'NCT03854435', 'briefTitle': 'Determination of Heart Rate in Infants Needing Resuscitation at Birth', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Padova'}, 'officialTitle': 'Determination of Heart Rate in Infants Needing Resuscitation at Birth', 'orgStudyIdInfo': {'id': 'University of Padova'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heart rate assessed by using a stethoscope (auscultation)', 'description': 'Heart rate will be assessed by using a stethoscope (auscultation) in newborn infants immediately after birth', 'interventionNames': ['Other: Heart rate assessment (stethoscope)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heart rate assessed by palpation of the umbilical cord', 'description': 'Heart rate will be assessed by palpation of the umbilical in newborn infants immediately after birth', 'interventionNames': ['Other: Heart assessment (umbilical cord palpation)']}], 'interventions': [{'name': 'Heart rate assessment (stethoscope)', 'type': 'OTHER', 'description': 'Immediately after birth heart rate will be evaluated by auscultation', 'armGroupLabels': ['Heart rate assessed by using a stethoscope (auscultation)']}, {'name': 'Heart assessment (umbilical cord palpation)', 'type': 'OTHER', 'description': 'Immediately after birth heart rate will be evaluated by palpation of the umbilical cord', 'armGroupLabels': ['Heart rate assessed by palpation of the umbilical cord']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Addis Ababa', 'country': 'Ethiopia', 'facility': 'St. Luke Catholic Hospital, Wolisso, Ethiopia', 'geoPoint': {'lat': 9.02497, 'lon': 38.74689}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Padova', 'class': 'OTHER'}, 'collaborators': [{'name': 'CUAMM Doctors with Africa, Padova, Italy', 'class': 'UNKNOWN'}, {'name': 'St. Luke Catholic Hospital, Wolisso, Ethiopia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Daniele Trevisanuto', 'investigatorAffiliation': 'University Hospital Padova'}}}}