Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 6:35 AM
Study NCT ID:
NCT04070560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-17
First Post:
2019-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012151', 'term': 'Resuscitation'}], 'ancestors': [{'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Thompson score', 'timeFrame': '1 hour after birth', 'description': 'Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.'}, {'measure': 'Thompson score', 'timeFrame': '6 hours after birth', 'description': 'Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.'}, {'measure': 'Thompson score', 'timeFrame': '12 hours after birth', 'description': 'Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.'}, {'measure': 'Thompson score', 'timeFrame': '24 hours after birth', 'description': 'Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.'}, {'measure': 'Thompson score', 'timeFrame': '48 hours after birth', 'description': 'Assessed by staff at neonatal intensive care unit. A scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Minimum 0 (normal), maximum 22. A score ≥12 is associated with adverse outcomes.'}], 'primaryOutcomes': [{'measure': 'Apgar score', 'timeFrame': 'At 5 minutes after birth', 'description': 'Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.'}], 'secondaryOutcomes': [{'measure': 'Apgar score', 'timeFrame': 'At 1 minute after birth', 'description': 'Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.'}, {'measure': 'Apgar score', 'timeFrame': 'At 10 minute after birth', 'description': 'Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.'}, {'measure': 'Time of first cry or breathing effort', 'timeFrame': 'Within 10 minutes after birth', 'description': 'Assessed by staff present'}, {'measure': 'Time of establishing spontaneous breathing', 'timeFrame': 'Within 10 minutes after birth', 'description': 'Assessed by staff present'}, {'measure': 'Presence at one day of age', 'timeFrame': '24 hours', 'description': 'The place of stay for newborn at one day of age'}, {'measure': 'Need of neonatal intensive care', 'timeFrame': '7 days', 'description': 'Admission to neonatal intensive care unit'}, {'measure': 'Score for Neonatal Acute Physiology (SNAP-II)', 'timeFrame': '7 days', 'description': 'Assessed by staff at neonatal intensive care unit'}, {'measure': 'Morbidity Assessment Index for Newborns (MAIN)', 'timeFrame': '7 days', 'description': 'Assessed by staff at neonatal intensive care unit'}, {'measure': 'Blood glucose', 'timeFrame': '4 hours after birth', 'description': 'Sampled by staff at nursery of neonatal intensive care'}, {'measure': 'Breathing difficulties', 'timeFrame': '1 hours after birth', 'description': 'Respiratory rate \\> 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care'}, {'measure': 'Breathing difficulties', 'timeFrame': '6 hours after birth', 'description': 'Respiratory rate \\> 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care'}, {'measure': 'Mortality', 'timeFrame': 'One year', 'description': 'Death after birth'}, {'measure': 'Development', 'timeFrame': '12 months', 'description': 'Assessed by Ages and Stages Questionnaire (ASQ). Minimum 0, maximum 300. Consist of 30 questions answered Yes (10), Sometimes (5), Not Yet (0). Five sub scales with six questions each: Communication, Fine motor, Gross motor, Problem solving and Personal-Social. Worse outcome is considered mean minus 2 standard deviations.'}, {'measure': 'Development', 'timeFrame': '24 months', 'description': 'Neurocognitive assessment by Bayley-III (alternative Bayley-IV if available). Derives a developmental quotient (DQ) three main subtests; the Cognitive Scale, the Language Scale, and the Motor Scale. Is assessed by special staff and have standardized interpretations of results.'}, {'measure': 'Autism', 'timeFrame': '24 months', 'description': 'Screening by Modified Checklist for Autism in Toddlers (M-CHAT). 20-question test. Answers "yes" or "no". A total score of 2 and below on the first part of the M-CHAT indicate low autism risk, a total score of 3-7 indicates medium risk and prompts administration of the follow-up form. A total score of 8 or higher indicates high autism risk.'}, {'measure': 'Development', 'timeFrame': '54 months', 'description': 'Neurocognitive assessment by Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV). 14 subtests. The core subtests are required for the computation of the Verbal, Performance, and Full Scale intelligence quotient (IQ). Also, two other composites Processing Speed Quotient and General Language Composite.\n\nQuotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3. For Quotient and Composite score:\n\nbelow 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior.'}, {'measure': 'Motor development', 'timeFrame': '54 months', 'description': 'Assessed by Movement Assessment Battery for Children (ABC). The test contains 8 tasks covering the following 3 areas: Manual Dexterity, Ball Skills, Static and Dynamic Balance. Standard scores for each domain can be compared to normative data and interpreted in terms of percentile equivalents (a) ≤5th percentile reflecting definite motor impairment, (b) ≤15th percentile reflecting borderline motor impairment, or (c) \\>15th percentile reflecting no motor impairment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['umbilical cord'], 'conditions': ['Asphyxia Neonatorum', 'Resuscitation']}, 'referencesModule': {'references': [{'pmid': '24055300', 'type': 'BACKGROUND', 'citation': 'Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.'}, {'pmid': '28526223', 'type': 'BACKGROUND', 'citation': 'Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.'}, {'pmid': '31013574', 'type': 'BACKGROUND', 'citation': 'Katheria AC. Neonatal Resuscitation with an Intact Cord: Current and Ongoing Trials. Children (Basel). 2019 Apr 22;6(4):60. doi: 10.3390/children6040060.'}, {'pmid': '31485335', 'type': 'BACKGROUND', 'citation': 'Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.'}, {'pmid': '35883044', 'type': 'BACKGROUND', 'citation': 'Ekelof K, Saether E, Santesson A, Wilander M, Patriksson K, Hesselman S, Thies-Lagergren L, Rabe H, Andersson O. A hybrid type I, multi-center randomized controlled trial to study the implementation of a method for Sustained cord circulation And VEntilation (the SAVE-method) of late preterm and term neonates: a study protocol. BMC Pregnancy Childbirth. 2022 Jul 26;22(1):593. doi: 10.1186/s12884-022-04915-5.'}, {'pmid': '36646247', 'type': 'BACKGROUND', 'citation': 'Wilander M, Sandblom J, Thies-Lagergren L, Andersson O, Svedenkrans J. Bilirubin Levels in Neonates >/=35 Weeks of Gestation Receiving Delayed Cord Clamping for an Extended Time-An Observational Study. J Pediatr. 2023 Jun;257:113326. doi: 10.1016/j.jpeds.2023.01.005. Epub 2023 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut.', 'detailedDescription': 'The routine procedure when a newborn baby is in need of resuscitation is to cut the umbilical cord and move the baby to a designated area for resuscitation, which can include stimulation, clearing the airways, administration of oxygen and/or positive pressure ventilation by bag and mask och T-piece resuscitator.\n\nIt has been suggested, and pilot studies has shown preliminary results, that keeping the umbilical cord intact while performing resuscitation may improve the babies outcome, by continued exchange of oxygen and carbon dioxide be the placenta and facilitating the neonatal pulmonary and circulatory transition.\n\nBecause of the limiting length of the umbilical cord, resuscitation with an intact cord must be performed in close proximity to the mother.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '35 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy week ≥35 + 0\n* Singletons\n* Expected vaginal delivery\n* The woman / couple can adequately assimilate information about the study\n* Signed informed consent of both prospective parents\n\nExclusion Criteria:\n\n* Congenital malformation that complicates resuscitation (such as severe malformation of mouth, pharynx, respiratory system) or which causes the child not to be resuscitated due to internal structural malformations (such as more severe heart failure, diaphragm fractures, etc.)\n* The child is born via acute caesarean section after inclusion and opening of study envelope\n* placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth)'}, 'identificationModule': {'nctId': 'NCT04070560', 'acronym': 'SAVE', 'briefTitle': 'Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'SAVE (Sustained Cord Circulation Awaiting VEntilation)', 'orgStudyIdInfo': {'id': 'SAVE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early (≤ 60 seconds) cord clamping', 'description': "If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table Other Name: Immediate clamping", 'interventionNames': ['Procedure: Early (≤ 60 seconds) cord clamping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intact cord (≥ 180 seconds) resuscitation', 'description': "If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother\n\nOther Names:\n\nLate cord clamping Deferred cord clamping Optimal cord clamping", 'interventionNames': ['Procedure: Intact cord (≥ 180 seconds) resuscitation']}], 'interventions': [{'name': 'Intact cord (≥ 180 seconds) resuscitation', 'type': 'PROCEDURE', 'description': 'Resuscitation performed in near proximity to the mother with umbilical cord uncut', 'armGroupLabels': ['Intact cord (≥ 180 seconds) resuscitation']}, {'name': 'Early (≤ 60 seconds) cord clamping', 'type': 'PROCEDURE', 'description': 'Resuscitation performed at a designated area after umbilical cord is cut', 'armGroupLabels': ['Early (≤ 60 seconds) cord clamping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30185', 'city': 'Halmstad', 'state': 'Halland County', 'country': 'Sweden', 'facility': 'Hospital of Halland', 'geoPoint': {'lat': 56.67446, 'lon': 12.85676}}, {'zip': '21428', 'city': 'Malmo', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Ystad', 'country': 'Sweden', 'facility': 'Ystad hospital', 'geoPoint': {'lat': 55.42966, 'lon': 13.82041}}], 'overallOfficials': [{'name': 'Ola Andersson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lunds University/Skåne University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Researchers who provide a methodologically sound proposal, and that most preferably have an approval from an independent review committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Skane University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}