SI + CC Versus 3:1 C:V Ratio During Neonatal CPR

NCT02858583 | Completed Results DMC

• 1 other identifier: 1.0
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 4

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.

Conditions

Heart Arrest; Birth Asphyxia; Bradycardia

Keywords

Chest Compression; Newborn; Infant; Sustained Inflation

Outcome Measures

Primary Outcomes (1)

• Return of Spontaneous Circulation

  Duration of chest compression heart rate is \>60/min for 60sec.

  up to 60 Minutes of chest compression

Secondary Outcomes (4)

• Mortality

  Until infant is discharge from hospital (maximum of 30 weeks after birth)

• Rate of Brain Injury - Intraventricular Hemorrhage

  Until infant is discharge from hospital (maximum of 30 weeks after birth)

• Necrotizing Enterocolitis

  Until infant is discharge from hospital (maximum of 30 weeks after birth)

• Epinephrine Doses Via Umbilical Venous Catheter

  during resuscitation at birth

Study Arms (2)

Intervention (CC+SI)

EXPERIMENTAL

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.

Procedure: CC+SI

Control (3:1 C:V)

ACTIVE COMPARATOR

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.

Procedure: 3:1 C:V

Interventions

CC+SI PROCEDURE

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.

Intervention (CC+SI)

3:1 C:V PROCEDURE

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.

Control (3:1 C:V)

Eligibility Criteria

• Age: 0 Minutes - 20 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants (term or preterm infants \>28 weeks' gestation) requiring CC in the delivery room will be eligible for the trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (4)

Medical University Graz

Graz, Austria

Location

Medical University Vienna

Vienna, Austria

Location

Royal Alexandra Hospital

Edmonton, Canada

Location

IWK Health Centre

Halifax, Canada

Location

Related Publications (31)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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  PMID: 11827933 BACKGROUND

• Schmolzer GM, Pichler G, Solevag AL, Law BHY, Mitra S, Wagner M, Pfurtscheller D, Yaskina M, Cheung PY; SURV1VE- Trial Investigators. Sustained inflation and chest compression versus 3:1 chest compression to ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns (SURV1VE): A cluster randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):428-435. doi: 10.1136/archdischild-2023-326383.

  PMID: 38212104 DERIVED

• Schmolzer GM, Pichler G, Solevag AL, Fray C, van Os S, Cheung PY; SURV1VE trial collaborators. The SURV1VE trial-sustained inflation and chest compression versus 3:1 chest compression-to-ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns: study protocol for a cluster randomized controlled trial. Trials. 2019 Feb 19;20(1):139. doi: 10.1186/s13063-019-3240-8.

  PMID: 30782199 DERIVED

MeSH Terms

Conditions

Heart Arrest; Asphyxia Neonatorum; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Georg Schmölzer
• Organization: University of Alberta

schmolze@ualberta.ca

780-735-4647

Study Officials

• Georg Schmolzer

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2016
• First Posted: August 8, 2016
• Study Start: October 19, 2017
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: August 29, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-08

Locations

AU (2); CA (2)