Resuscitation Clinical Trial
— SAVEOfficial title:
SAVE (Sustained Cord Circulation Awaiting VEntilation)
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2026 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Weeks to 42 Weeks |
Eligibility | Inclusion Criteria: - Pregnancy week =35 + 0 - Singletons - Expected vaginal delivery - The woman / couple can adequately assimilate information about the study - Signed informed consent of both prospective parents Exclusion Criteria: - 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.) - The child is born via acute caesarean section after inclusion and opening of study envelope - placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth) |
Country | Name | City | State |
---|---|---|---|
Sweden | Hospital of Halland | Halmstad | Halland |
Sweden | Skåne University Hospital | Malmö | Skåne |
Sweden | Ystad hospital | Ystad |
Lead Sponsor | Collaborator |
---|---|
Lund University | Skane University Hospital |
Sweden,
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. — View 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. — View 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. — View 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. Erratum In: Children (Basel). 2019 May 21;6(5): — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Thompson score | 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. | 1 hour after birth | |
Other | Thompson score | 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. | 6 hours after birth | |
Other | Thompson score | 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. | 12 hours after birth | |
Other | Thompson score | 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. | 24 hours after birth | |
Other | Thompson score | 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. | 48 hours after birth | |
Primary | Apgar score | 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. | At 5 minutes after birth | |
Secondary | Apgar score | 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. | At 1 minute after birth | |
Secondary | Apgar score | 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. | At 10 minute after birth | |
Secondary | Time of first cry or breathing effort | Assessed by staff present | Within 10 minutes after birth | |
Secondary | Time of establishing spontaneous breathing | Assessed by staff present | Within 10 minutes after birth | |
Secondary | Presence at one day of age | The place of stay for newborn at one day of age | 24 hours | |
Secondary | Need of neonatal intensive care | Admission to neonatal intensive care unit | 7 days | |
Secondary | Score for Neonatal Acute Physiology (SNAP-II) | Assessed by staff at neonatal intensive care unit | 7 days | |
Secondary | Morbidity Assessment Index for Newborns (MAIN) | Assessed by staff at neonatal intensive care unit | 7 days | |
Secondary | Blood glucose | Sampled by staff at nursery of neonatal intensive care | 4 hours after birth | |
Secondary | Breathing difficulties | Respiratory rate > 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care | 1 hours after birth | |
Secondary | Breathing difficulties | Respiratory rate > 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care | 6 hours after birth | |
Secondary | Mortality | Death after birth | One year | |
Secondary | Development | 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. | 12 months | |
Secondary | Development | 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. | 24 months | |
Secondary | Autism | 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. | 24 months | |
Secondary | Development | 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.
Quotient 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: below 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. |
54 months | |
Secondary | Motor development | 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. | 54 months |
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