Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02858583




Registration number
NCT02858583
Ethics application status
Date submitted
30/07/2016
Date registered
8/08/2016
Date last updated
22/02/2023

Titles & IDs
Public title
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Scientific title
SURV1VE-Trial - Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns: A Randomized Controlled Trial
Secondary ID [1] 0 0
1.0
Universal Trial Number (UTN)
Trial acronym
SURV1VE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrest 0 0
Birth Asphyxia 0 0
Bradycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system
Cardiovascular 0 0 0 0
Coronary heart disease
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - CC+SI
Treatment: Surgery - 3:1 C:V

Experimental: Intervention (CC+SI) - Infants randomized into the "CC+SI group" will receive a SI with a PIP of 25-30 cmH2O while receiving chest compression. The SI will be delivered over a period of 45 seconds. This will be followed by PEEP of 5-8 cm water to perform an assessment of the newborn's heart rate. If heart rate is >60/min continue with standard care as per local hospital policy (standard hospital practice guideline). If heart rate remains <60/min continue with CC+SI for another 45sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI.

Active Comparator: Control (3:1 C:V) - Infants randomized into the "3:1 C:V group" will receive CC at a rate of 90/min and 30 ventilations/min in a 3:1 C:V ratio as recommended by the current resuscitation guidelines.


Treatment: Surgery: CC+SI
chest compression will be delivered during sustained inflation (CC+SI). The duration of each sustain inflation is 20sec. After 20sec a pause of 1sec id done before the next sustained inflation is delivered for another 20sec. Chest compressions are given continuously. This approach is continued until return of spontaneous circulation.

Treatment: Surgery: 3:1 C:V
During 3:1 C:V. 3 chest compressions are given, then stopped and then 1 inflation is given. This approach is continued until return of spontaneous circulation.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Return of spontaneous Circulation
Timepoint [1] 0 0
up to 60 Minutes of chest compression
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
Until infant is discharge from hospital (maximum of 30 weeks after birth)
Secondary outcome [2] 0 0
Number of Epinephrine dosses during resuscitation
Timepoint [2] 0 0
During resuscitation (up to 60 minutes)
Secondary outcome [3] 0 0
Rate of brain injury
Timepoint [3] 0 0
Until infant is discharge from hospital (maximum of 30 weeks after birth)
Secondary outcome [4] 0 0
Necrotizing enterocolitis
Timepoint [4] 0 0
Until infant is discharge from hospital (maximum of 30 weeks after birth)

Eligibility
Key inclusion criteria
- Infants (term or preterm infants >28 weeks' gestation) requiring CC in the delivery
room will be eligible for the trial.
Minimum age
0 Minutes
Maximum age
20 Minutes
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Infants will be excluded if they have a congenital abnormality or condition that might
have an adverse effect on breathing or ventilation (e.g. congenital diaphragmatic
hernia), or congenital heart disease requiring intervention in the neonatal period.
Infants would be also excluded if their parents refused to give consent to this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2022
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Canada
State/province [3] 0 0
Edmonton
Country [4] 0 0
Canada
State/province [4] 0 0
Halifax

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Research question In newborn infants requiring CPR, does CC superimposed by sustained
inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous
circulation?

Overall objective: CC superimposed by sustained inflation will improve short- and long-term
outcomes in preterm (>28 weeks or older) and term newborns.

Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation
(CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC)
compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated
newborns.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02858583
Trial related presentations / publications
Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available.
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.
Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available.
Schmolzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7.
Li ES, Gorens I, Cheung PY, Lee TF, Lu M, O'Reilly M, Schmolzer GM. Chest Compressions during Sustained Inflations Improve Recovery When Compared to a 3:1 Compression:Ventilation Ratio during Cardiopulmonary Resuscitation in a Neonatal Porcine Model of Asphyxia. Neonatology. 2017;112(4):337-346. doi: 10.1159/000477998. Epub 2017 Aug 3.
Solevag AL, Schmolzer GM. Optimal Chest Compression Rate and Compression to Ventilation Ratio in Delivery Room Resuscitation: Evidence from Newborn Piglets and Neonatal Manikins. Front Pediatr. 2017 Jan 23;5:3. doi: 10.3389/fped.2017.00003. eCollection 2017.
Li ES, Cheung PY, Lee TF, Lu M, O'Reilly M, Schmolzer GM. Return of spontaneous Circulation Is Not Affected by Different Chest Compression Rates Superimposed with Sustained Inflations during Cardiopulmonary Resuscitation in Newborn Piglets. PLoS One. 2016 Jun 15;11(6):e0157249. doi: 10.1371/journal.pone.0157249. eCollection 2016.
Sobotka KS, Hooper SB, Crossley KJ, Ong T, Schmolzer GM, Barton SK, McDougall AR, Miller SL, Tolcos M, Klingenberg C, Polglase GR. Single Sustained Inflation followed by Ventilation Leads to Rapid Cardiorespiratory Recovery but Causes Cerebral Vascular Leakage in Asphyxiated Near-Term Lambs. PLoS One. 2016 Jan 14;11(1):e0146574. doi: 10.1371/journal.pone.0146574. eCollection 2016. Erratum In: PLoS One. 2016;11(5):e0156193.
Solevag AL, Cheung PY, O'Reilly M, Schmolzer GM. A review of approaches to optimise chest compressions in the resuscitation of asphyxiated newborns. Arch Dis Child Fetal Neonatal Ed. 2016 May;101(3):F272-6. doi: 10.1136/archdischild-2015-309761. Epub 2015 Dec 1.
Solevag AL, Cheung PY, Lie H, O'Reilly M, Aziz K, Nakstad B, Schmolzer GM. Chest compressions in newborn animal models: A review. Resuscitation. 2015 Nov;96:151-5. doi: 10.1016/j.resuscitation.2015.08.001. Epub 2015 Aug 19.
Li ES, Cheung PY, O'Reilly M, Schmolzer GM. Change in tidal volume during cardiopulmonary resuscitation in newborn piglets. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F530-3. doi: 10.1136/archdischild-2015-308363. Epub 2015 Jul 1.
Sobotka KS, Polglase GR, Schmolzer GM, Davis PG, Klingenberg C, Hooper SB. Effects of chest compressions on cardiovascular and cerebral hemodynamics in asphyxiated near-term lambs. Pediatr Res. 2015 Oct;78(4):395-400. doi: 10.1038/pr.2015.117. Epub 2015 Jun 18.
Schmolzer GM, Kumar M, Aziz K, Pichler G, O'Reilly M, Lista G, Cheung PY. Sustained inflation versus positive pressure ventilation at birth: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F361-8. doi: 10.1136/archdischild-2014-306836. Epub 2014 Dec 30.
Li ES, Cheung PY, Pichler G, Aziz K, Schmolzer GM. Respiratory function and near infrared spectroscopy recording during cardiopulmonary resuscitation in an extremely preterm newborn. Neonatology. 2014;105(3):200-4. doi: 10.1159/000357609. Epub 2014 Jan 24.
Schmolzer GM, O'Reilly M, Labossiere J, Lee TF, Cowan S, Nicoll J, Bigam DL, Cheung PY. 3:1 compression to ventilation ratio versus continuous chest compression with asynchronous ventilation in a porcine model of neonatal resuscitation. Resuscitation. 2014 Feb;85(2):270-5. doi: 10.1016/j.resuscitation.2013.10.011. Epub 2013 Oct 22.
Schmolzer GM, O'Reilly M, Labossiere J, Lee TF, Cowan S, Qin S, Bigam DL, Cheung PY. Cardiopulmonary resuscitation with chest compressions during sustained inflations: a new technique of neonatal resuscitation that improves recovery and survival in a neonatal porcine model. Circulation. 2013 Dec 3;128(23):2495-503. doi: 10.1161/CIRCULATIONAHA.113.002289. Epub 2013 Oct 2.
Solevag AL, Lee TF, Lu M, Schmolzer GM, Cheung PY. Tidal volume delivery during continuous chest compressions and sustained inflation. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F85-F87. doi: 10.1136/archdischild-2016-311043. Epub 2016 Aug 26.
Boldingh AM, Solevag AL, Aasen E, Nakstad B. Resuscitators who compared four simulated infant cardiopulmonary resuscitation methods favoured the three-to-one compression-to-ventilation ratio. Acta Paediatr. 2016 Aug;105(8):910-6. doi: 10.1111/apa.13339. Epub 2016 Feb 18.
Dannevig I, Solevag AL, Saugstad OD, Nakstad B. Lung Injury in Asphyxiated Newborn Pigs Resuscitated from Cardiac Arrest - The Impact of Supplementary Oxygen, Longer Ventilation Intervals and Chest Compressions at Different Compression-to-Ventilation Ratios. Open Respir Med J. 2012;6:89-96. doi: 10.2174/1874306401206010089. Epub 2012 Sep 20.
Solevag AL, Madland JM, Gjaerum E, Nakstad B. Minute ventilation at different compression to ventilation ratios, different ventilation rates, and continuous chest compressions with asynchronous ventilation in a newborn manikin. Scand J Trauma Resusc Emerg Med. 2012 Oct 17;20:73. doi: 10.1186/1757-7241-20-73.
Solevag AL, Dannevig I, Wyckoff M, Saugstad OD, Nakstad B. Return of spontaneous circulation with a compression:ventilation ratio of 15:2 versus 3:1 in newborn pigs with cardiac arrest due to asphyxia. Arch Dis Child Fetal Neonatal Ed. 2011 Nov;96(6):F417-21. doi: 10.1136/adc.2010.200386. Epub 2011 Mar 10.
Dannevig I, Solevag AL, Wyckoff M, Saugstad OD, Nakstad B. Delayed onset of cardiac compressions in cardiopulmonary resuscitation of newborn pigs with asphyctic cardiac arrest. Neonatology. 2011;99(2):153-62. doi: 10.1159/000302718. Epub 2010 Sep 11.
Solevag AL, Dannevig I, Wyckoff M, Saugstad OD, Nakstad B. Extended series of cardiac compressions during CPR in a swine model of perinatal asphyxia. Resuscitation. 2010 Nov;81(11):1571-6. doi: 10.1016/j.resuscitation.2010.06.007. Epub 2010 Jul 17.
Chandra N, Rudikoff M, Weisfeldt ML. Simultaneous chest compression and ventilation at high airway pressure during cardiopulmonary resuscitation. Lancet. 1980 Jan 26;1(8161):175-8. doi: 10.1016/s0140-6736(80)90662-5.
Tsui BC, Horne S, Tsui J, Corry GN. Generation of tidal volume via gentle chest pressure in children over one year old. Resuscitation. 2015 Jul;92:148-53. doi: 10.1016/j.resuscitation.2015.02.021. Epub 2015 Mar 4.
Babbs CF, Meyer A, Nadkarni V. Neonatal CPR: room at the top--a mathematical study of optimal chest compression frequency versus body size. Resuscitation. 2009 Nov;80(11):1280-4. doi: 10.1016/j.resuscitation.2009.07.014. Epub 2009 Aug 27.
Hemway RJ, Christman C, Perlman J. The 3:1 is superior to a 15:2 ratio in a newborn manikin model in terms of quality of chest compressions and number of ventilations. Arch Dis Child Fetal Neonatal Ed. 2013 Jan;98(1):F42-5. doi: 10.1136/archdischild-2011-301334. Epub 2012 Apr 3.
Srikantan SK, Berg RA, Cox T, Tice L, Nadkarni VM. Effect of one-rescuer compression/ventilation ratios on cardiopulmonary resuscitation in infant, pediatric, and adult manikins. Pediatr Crit Care Med. 2005 May;6(3):293-7. doi: 10.1097/01.PCC.0000161621.74554.15.
Kern KB, Hilwig RW, Berg RA, Sanders AB, Ewy GA. Importance of continuous chest compressions during cardiopulmonary resuscitation: improved outcome during a simulated single lay-rescuer scenario. Circulation. 2002 Feb 5;105(5):645-9. doi: 10.1161/hc0502.102963.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Georg Schmolzer
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02858583