SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Condition: Heart Arrest; Birth Asphyxia; Bradycardia
MeSH terms: Bradycardia; Heart Arrest; Asphyxia Neonatorum; Asphyxia
Study type: Interventional

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.
    

Detailed description: 
      Background The majority of newborn infants successfully make the transition from fetal to
      neonatal life without any help. However, an estimated 10% of newborns need help to establish
      effective ventilation, which remains the most critical step of neonatal resuscitation.
      Fortunately, the need for chest compression (CC) or medications in the delivery room (DR) is
      rare. Although, only about 0.1% of term infants and up to 15% of preterm infants receive
      these interventions, this will result in approximately 1 million newborn deaths annually
      worldwide. A recent cohort study at a level III center with a trained resuscitation team
      showed that only 6 per 10,000 infants received epinephrine. However, the same study showed
      that those infants who received epinephrine during resuscitation had a high incidence of
      mortality (41%) and short-term neurologic morbidity (57% hypoxic-ischemic encephalopathy and
      seizures)4. A recent review of newborns who received prolonged CC and epinephrine but had no
      signs of life at 10 minutes following birth noted 83% mortality, with 93% of survivors
      suffering moderate-to-severe disability. The poor prognosis associated with receiving CC
      alone or with medications in the DR raises questions as to whether improved cardiopulmonary
      resuscitation (CPR) methods specifically tailored to the newborn could improve outcomes.

      The inability to predict which newborns need CPR, and the infrequent use of CPR in the DR
      have limited neonatologists' ability to perform rigorous clinical studies to determine the
      best method for delivering CC to newborn infants. The main cause of cardiovascular collapse
      in most newborns is asphyxia, which makes newborn infants distinctively different to the
      adult population. The International Liaison Committee on Resuscitation and the American
      Academy of Pediatrics/American Heart Association Neonatal Resuscitation Program have
      recognize this difference, however the guidelines almost exclusively rely on data from
      studies in the adult population or animal studies. Such data may not be wholly applicable to
      the neonatal population because the most common cause of cardiovascular collapse in the adult
      is ventricular fibrillation, not asphyxia. Thus, further studies are needed to determine the
      optimal method for improving hemodynamics and recovery during neonatal resuscitation.

      Research question In newborn infants (preterm infants >28 weeks' gestation and term infants)
      requiring CPR, does CC during sustained inflation compared to 3:1 compression to ventilation
      ratio improves return of spontaneous circulation (ROSC)?

      Primary objective: To prove that CC during sustained inflation will improve recovery from CPR
      in preterm and term newborns with faster ROSC than that by 3:1 CPR technique.

      Secondary objectives: To examine i) if CC during sustained inflation will improve short- and
      long-term outcomes in preterm and term newborns, and ii) the value of feedback devices (e.g.
      ECO2, ECG and/or SpO2) in determining ROSC.

      Hypotheses to be tested Primary hypothesis: By using CC during sustained inflation (CC+SI)
      during CPR the time needed to achieve ROSC compared to the current 3:1 compression to
      ventilation (C:V) ratio will be reduced in asphyxiated newborns.

      Secondary hypotheses: The benefits associated with CC+SI will i) decrease death; ii) improve
      short- and long-term outcomes in preterm and term newborns; and iii) feedback devices help to
      determine ROSC.

      Methodology Ethics This multi-center cluster randomized clinical trial will be reviewed by
      the appropriate Research Ethics Office at all participating sites. We will request a deferred
      consent model at all sites (see parental consent paragraph for details). Written consent will
      be sought from the parents of these infants as soon as possible after the birth so that
      acquired data could be utilized for research35.

      Inclusion criteria All infants (term or preterm infants >28 weeks' gestation) requiring CC in
      the delivery room will be eligible for the trial.

      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 will be also excluded if their parents refuse to give consent to this study.

      Randomization At the beginning of the trial participating sites will be randomized. Centers
      will be equally allocated to either CC+SI group ("intervention group") or 3:1 C:V group
      ("control group") for the first year. For the second year, after a wash out period of 2
      months, centers in the intervention group will be changed to control and vice versa.

      Sample Size and Power calculation Our primary outcome measure will be time to achieve ROSC.
      We hypothesize that the time to achieve ROSC will be reduced in the "CC+SI group". A sample
      size of 208 infants, 104 in each group, would be sufficient to detect a clinically important
      33% reduction in time to achieve ROSC using Cox proportional hazards regression with 80%
      power and a 2-tailed alpha error of 0.05. This 33% reduction represents 282 sec versus 420
      sec of CC (based on the database of 30 term infants requiring CC in 2014 and 2015 at the
      Royal Alexandra Hospital, Edmonton). To account for cluster randomization, the sample size is
      multiplied by design effect of 1.045, so the total sample size is 218 infants, 109 in each
      group.

      Blinding There will be no blinding during the recruitment phase. Each hospital is allocated
      to one treatment arm and therefore the CC technique used at each particular site is known to
      the clinical team. The outcome assessor will be unaware of the group allocation. This
      blinding will be maintained until the data is locked for the final analysis and un-blinded.

      Technique of Resuscitation Infants will only be eligible and randomized if they require chest
      compressions. The methods described below also describe resuscitation interventions for
      infants prior to the start of chest compressions.

      Description of general interventions Term infants The initial steps of the resuscitation will
      be according to the current neonatal resuscitation guidelines1. Delayed cord clamping should
      be performed as per local hospital policy (standard hospital practice guideline) at
      participating sites where eligible. Afterwards, dry and stimulate the infant, and open the
      airway. If heart rate is <100/min, the infant is gasping or has apnea, start positive
      pressure ventilation. At the same time consider attaching a pulse oximeter and also consider
      applying electrocardiography. If heart rate remains <100/min, perform MR. SOPA (Mask is
      tightly applied to the face, Re-position the head into the "sniffing" orientation, Suction
      the nares and the pharynx, Open the mouth, Pressure of PPV can be increased to a max of 40 cm
      H2O, Alternate airway (endotracheal tube or Laryngeal Mask Airway). If heart rate is <60/min
      or remains <60 despite all steps of MR. SOPA including alternate airway, start chest
      compressions and increase to 100% oxygen.

      Preterm infants The initial steps of the resuscitation will be according to the current
      neonatal resuscitation guidelines1. Delayed cord clamping should be performed as per local
      hospital policy (standard hospital practice guideline) at participating sites where eligible.
      Immediately afterwards, preterm infants (according to local hospital policy - standard
      hospital practice guideline) will be either placed (without drying) in a polyethylene bag
      under radiant heat44 or dried and placed under radiant heat.

      A pulse oximeter will be used to monitor oxygen saturation immediately after birth and oxygen
      delivery will be guided by published norm values for oxygen saturation in preterm infants45.

      If heart rate is <100/min, the infant is gasping or has apnea, start positive pressure
      ventilation. Also consider applying electrocardiography at that time. If heart rate remains
      <100/min, perform MR. SOPA (Mask is tightly applied to the face, Re-position the head into
      the "sniffing" orientation, Suction the nares and the pharynx, Open the mouth, Pressure of
      PPV can be increased to a max of 40 cm H2O, Alternate airway (endotracheal tube or Laryngeal
      Mask Airway). If heart rate is <60/min or remains <60 despite all steps of MR. SOPA start
      chest compression and increase to 100% oxygen.

      Mask Ventilation The clinical team will determine if an infant requires mask ventilation. If
      mask ventilation is required, it should be provided with a T-Piece device (e.g. Fisher &
      Paykel, Auckland, New Zealand or Giraffe Warmer, GE Health Care, Burnaby, BC, Canada), and
      appropriate face mask with default settings for peak inflation pressure (PIP) of 25 cmH2O, a
      peep expiratory pressure (PEEP) of 5 cm H2O, and a gas flow rate of 8-10L/min using a
      ventilation rate of 40-60 inflations/min. Initial respiratory support can include initial
      sustained inflations (instead of positive pressure ventilation alone) as per local hospital
      policy (standard hospital practice guideline).

      Cardiopulmonary Resuscitation If heart rate is <60/min or remains <60/min despite all steps
      of MR. SOPA start chest compressions. Prior to the start of CC intubation should be
      considered. However, in cases of intubation failure it is possible to start CC during mask
      ventilation. Compressions will be performed using the 2-thumb encircling technique as
      recommended by current resuscitation guidelines46. Epinephrine will be administered according
      to current resuscitation guidelines either via umbilical vein catheter (0.01 mg/kg per dose -
      first line) or via endotracheal tube (0.05 mg/kg to 0.1 mg/kg) or every three to five minutes
      as needed44. Chest compressions and epinephrine will be continued until ROSC.

      Determination of ROSC ROSC will defined as an increase in heart rate >60/min for 60sec
      determined by auscultation of the heart. Return of spontaneous circulation will be assessed
      after 60sec of a heart rate of >60/min.

      The current neonatal resuscitation guidelines do not recommend feedback devices (e.g. exhaled
      carbon dioxide (ECO2) monitors, electrocardiography (ECG), or pulse oximetry for detection of
      ROSC1. A secondary objective of the study will be to examine if either feedback device ECO2,
      ECG or pulse oximetry can be used for detection of ROSC. Participating centres (e.g.
      Edmonton, Graz, Winnipeg, Ulm, San Diego) are using either ECO2 monitors, ECG, and/or pulse
      oximetry routinely during neonatal resuscitation35,47-49.

      Interventions "3:1 C:V group" If the PIP has been increased >30 cm H2O during MR.SOPA, the
      PIP should be decreased to 30 cmH2O prior start of chest compression. Infants randomized into
      the "3:1 C:V group" will receive CC at a rate of 90/min and ventilations at a rate of 30 /min
      in a 3:1 C:V ratio as recommended by the current resuscitation guidelines1 (study flow
      diagram). During CC, the inflations should be delivered using a PIP of 25-30 cmH2O (As per
      local hospital policy /standard hospital practice guideline). Heart rate should be
      reevaluated every 60sec according to current neonatal resuscitation guidelines1.

      "CC+SI group" If the PIP has been increased >30 cm H2O during MR.SOPA, the PIP should be
      decreased to 30 cmH2O prior start of chest compression. Infants randomized into the "CC+SI
      group" will receive a SI with a PIP 25-30 cmH2O while receiving CC. CC will be performed at a
      rate of 90/min. The SI will be delivered over a period of 20 seconds. This will be followed
      by PEEP of 5-8 cm water as per local hospital policy (standard hospital practice guideline)
      for one second. Then the next SI for 20sec is started while CCs are continued. Again after
      20sec there will be a 1sec pause with PEEP, which will be followed by another SI for 20sec
      with continuous CC. After 3x20sec SI+CC (total of 60sec) an assessment of heart rate should
      be performed. 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 60sec (3x20sec SI+CC (total of 60sec) at which time a further assessment
      should be performed. If heart rate remains <60/min continue with CC+SI. If CPR is ongoing for
      5 minutes using SI+CC, the clinical team must convert to the standard method of care using
      3:1 C:V ratio.

      Discontinuing Resuscitation Deciding how long resuscitative efforts should continue in any of
      the study infants will be solely at the discretion of the clinical team in accordance with
      the current neonatal resuscitation guidelines1 and per local hospital policy (standard
      hospital practice guideline) at every participating site.

      18-24 months follow-up SI+CC might result in improved pCO2 during CPR. A more favourable pCO2
      might be neuro-protective, and we hypothesize that SI+CC infants will have a better
      neurodevelopmental outcome compared to infants randomized to 3:1 C:V. Most infants who
      receive chest compressions are routinely assessed for neurodevelopmental outcomes at 18-24
      months of age in the outpatient clinic in the study hospital. A Bayley III assessment
      (reference) will be performed by a psychologist or other professional with the relevant
      competence at the study site. This participant data will be collected at the 18-24 month
      follow up visit if this is part of routine care; it is not mandatory to collect.

      Outcome measures Primary outcome Time to achieve ROSC is defined as a heart rate of >60/min
      for 60sec determined by auscultation of the heart. Return of spontaneous circulation will be
      assessed after 60sec of a heart rate of >60/min.

      Secondary outcomes Secondary outcomes amongst others will include neonatal mortality
      (Neonatal death <28 days) and morbidities, for example, rates of brain injury (reported
      either via magnetic resonance imaging (MRI) or head ultrasound), changes in regional cerebral
      oxygen saturation using near-infrared spectroscopy (NIRS) monitoring started in the DR and
      discontinued when clinical stabilization is achieved, results of amplitude-integrated
      electroencephalograpy (aEEG) monitoring until normalization of background patterns and
      occurrence of sleep-wake cycling, DR interventions (including the use of epinephrine),
      admission temperature, use of therapeutic cooling, mechanical ventilation, pneumothorax, use
      of inotropes, infection/sepsis, intraventricular hemorrhages, necrotizing enterocolitis,
      bronchopulmonary dysplasia, retinopathy of prematurity and long-term neurodevelopmental
      outcomes. We will also assess the value of ECO2, ECG and/or SpO2 in determining ROSC as
      described previously.

      Outcome assessment tools Mortality: All causes of mortality will be recorded. Cerebral injury
      will be assessed with either cerebral ultrasound or cerebral MRI if performed prior to
      discharge. If an infant dies prior to any neuro-imaging, a request for autopsy should be
      made. Autopsy could include imaging alone or full autopsy. Morbidity: Case history until
      discharge or term age (for preterm infants). Secondary outcome parameters: Case history and
      output from feedback devices.

      Compliance with the Protocol The clinical investigation will be conducted in compliance with
      this protocol. Modifications to the protocol will not be implemented without agreement from
      the Principal Investigators and relevant ethics committee approval are obtained.

      Investigators are not allowed to deviate from the protocol except as specified above. Any
      major or safety related deviations will be recorded, analyzed and the ethics committees
      notified. If an investigator refuses to comply with the protocol he/she will be disqualified.

      Data collection Infants will be recruited over a period of 26 months. Approximately another
      six months will be required to collect hospital data on all infants enrolled. Resuscitation
      data will be collected on a standard form (Neonatal Resuscitation Record) that will form part
      of each infant's hospital record. The Neonatal Resuscitation Record should be completed by
      the clinical team attending the resuscitation. Other medical data on each infant will be
      collected on an electronic Case Report Form (eCRF). The eCRF will be designed in
      collaboration with Women and Children's Health Research Institute, University of Alberta,
      Edmonton, Canada. Data will be entered into REDCap database from each site within one week
      after discharge or death of an infant. Long-term follow-up will be entered within two weeks
      after examination. All information entered into REDCap database will be used for analysis.

      Data analysis The Clinical Research Informatics Core and Biostatistics Core of the Women and
      Children's Health Research Institute, at the University of Alberta, will do data management
      and analysis. Additional information about the storage, management and analysis of study data
      is available.

      All analyses will be carried out according to the intention-to-treat principle. Statistical
      analyses will be performed using IBM SPSS Statistics Ver. 24 (IBM Corp.) and SAS version 9.4
      (SAS Institute Inc.) or later.

      Interim Analysis Interim safety analysis will be performed at 10%, 25% and 50% of enrolment
      to review the primary outcome, ROSC, and severe adverse events (SAEs).

      Thus, three interim analyses will be performed at 22 patients (11 patients per group), 54 (27
      patients per group), and 110 (55 patients per group) to evaluate the efficacy of the
      intervention. At each interim analysis posterior probability of SI+CC arm to reduce time to
      ROSC by 10% or more compared to the control arm will be calculated. If this probability is
      less than 0.5, the trial will be stopped for futility. If the posterior probability is
      greater than 0.98, the Data and Safety Monitoring Board will consider the trial to be stopped
      for superiority. Since no statistical tests will be performed at interim analyses, type I
      error (alpha) does not need adjustment.

      Final Analysis Primary Analysis The primary outcome is the time to achieve ROSC defined as a
      heart rate of >60/min for 60sec. Data will be analyzed on an intention-to treat basis and
      will include all randomized participants. A per protocol analysis will also be conducted
      using the data from the actual allocation of participating infants. A survival analysis will
      be used to analyze the difference in time to ROSC between intervention and control groups. To
      account for cluster randomization, Cox proportional hazards regression with time to ROSC as
      an outcome and allocation group as an independent variable will be created. Centers will be
      entered as clusters in the model and the statistical significance of the allocation group
      variable will be evaluated. The analysis will be 2-sided and p-value < 0.05 will be
      considered statistically significant.

      Secondary Analysis The data will be presented as mean (standard deviation, SD) for normally
      distributed continuous variables and median (interquartile range, IQR) when the distribution
      is skewed. The clinical characteristics and outcome parameters will be compared using
      Student's t-test for parametric and Mann-Whitney U-test for nonparametric comparisons of
      continuous variables, and χ2 for categorical variables. All p-values will be 2-sided and p
      <0.05 will be considered statistically significant.

      Assessment of safety Adverse and Serious Adverse Events Infants who require CPR in the DR are
      a very seriously ill patient group. Most adverse events may be of a serious nature with or
      without the SURV1VE-trial intervention, and both intervention groups are expected to have a
      very high proportion of serious adverse events (SAEs). Serious adverse events to be recorded
      are therefore mortality within the DR (e.g. did not achieve ROSC or did achieve ROSC but care
      was withdrawn), and within the NICU (any mortality).

      Expected adverse events Adverse events we expect to be related to the application of the
      treatment guideline include: No ROSC leading to death, accidental displacement of the
      endotracheal tube or extubation, accidental displacement of venous or arterial catheters, use
      of Nitric Oxide for pulmonary hypertension, sepsis, pneumothorax, and intraventricular
      hemorrhage (grades 1-4)52.

      Data and Safety Monitoring Board A Data and Safety Monitoring Board (DSMB) will monitor the
      study to: (1) protect all study patients, (2) safeguard the interests of all study patients,
      (3) monitor the overall conduct of the trial, (4) advise the investigators in order to
      protect the integrity of the trial, and (5) supervise the conduct and analysis of all interim
      analyses. To its end the DSMB will receive regular reports from the trial on any injuries or
      adverse events, any developments that jeopardize the continued success of the trial, and data
      by which to accomplish the evaluation of pre-determined early stopping rules. Serious Adverse
      Events to be reported (mortality) will be sent within 72 hours to the DSMB; reports of
      other/less serious adverse events and recruitment will be sent monthly; demographics and
      adverse events (including pneumothorax, and intraventricular hemorrhage grade 3 or higher
      according to Papile52) will be included with the interim and final safety and efficacy
      analyses. The DSMB will perform interim safety analysis at 10%, 25% and 50% of enrolment to
      review the primary outcome of ROSC, and SAEs. At the discretion of the DSMB further interim
      analyses can be requested.

      Members of the DSMB are Myra Wyckoff (current Chair of the International Liaison Committee on
      Resuscitation (ILCOR), Neil Finer (Professor Emeritus, University of California San Diego),
      and Maryna Yaskina (Statistician, Biostatistics Unit, Women and Children's Health Research
      Institute, University of Alberta, Edmonton, Canada).

      Suspension or premature termination of the clinical investigation The sponsor/principal
      investigator and the ethics committees can make decisions about trial discontinuation. If the
      trial is terminated or suspended the parents of all trial participants will be informed and
      appropriate follow-up will be assured. If sponsor/principal investigator terminates or
      suspends the trial the relevant ethics committees will be provided with a detailed written
      explanation of the termination or suspension.

      The sponsor/principal investigator can, upon completion of the analysis of the reason(s) for
      a suspension, decide to lift the suspension when the necessary corrective actions have been
      implemented. The investigators and ethics committees will be notified and provided with the
      relevant data supporting the decision.

      Stopping rules

      The DSMB will review the data at interim analyses at 10%, 25% and 50%. Predefined stopping
      rules will include:

        1. An increased mortality in the SI+CC group by 25% compared to the 3:1 C:V group at the
           predefined interim analysis at 10%, 25% and 50%.

        2. Increase in rate of morbidities including pneumothorax, intraventricular hemorrhage or
           the combination, in the SI+CC group by 25% compared to the 3:1 C:V group at the
           predefined interim analysis at 10%, 25% and 50%.

        3. Bayesian posterior probability of SI+CC group being better than the control is less than
           0.5 or greater than 0.98. (Posterior probability of SI+CC arm to reduce time to ROSC by
           10% or more compared to the control arm will be calculated. If this probability is less
           than 0.5, the trial will be stopped for futility. If the posterior probability is
           greater than 0.98, DSMB will consider the trial to be stopped for superiority. Since no
           statistical tests will be performed at interim analyses, type I error (alpha) does not
           need adjustment).

      Opt-out Rule In any cases were CPR is ongoing for 5 minutes, the clinical team must convert
      to the standard method of care using the 3:1 C:V ratio.

      Ethical Considerations The SURV1VE-trial will be conducted in compliance with the guidelines
      of the Declaration of Helsinki in its latest form, the International Conference on
      Harmonization of Good Clinical Practice Guidelines. In case of modifications in the study
      protocol that are not merely of a formal nature but contain changes pertinent to the study
      participants, a renewed vote of the relevant ethics committees will be obtained. If
      applicable, the patients (parents) will be informed in the patient information and consent
      form about changes in the terms and conditions of the trial. The SURV1VE-trial will only
      start the randomization of participants after approvals from the relevant ethics committees
      have been obtained.

      Data management Data handling and archiving Source data will be registered in the
      participant's medical records/CRF and into the eCRF. A common web-based eCRF will be devised
      to enable a central database (Women and Children's Health Research Institute, University of
      Alberta, Edmonton, Canada). Data entry into the central database and handling of medical
      records is the responsibility of the investigators. After the establishment of a 'clean
      file', the database will be locked; The data will be locked after completion of patient
      recruitment and data entry. After long-term follow-up data entry this portion of the database
      will locked. Data will be stored for statistical analysis at the Biostatistics Unit, Women
      and Children's Health Research Institute, University of Alberta, Edmonton, Canada. The trial
      database will hereafter be kept according to the respective national laws. After the end of
      trial, the data will be archived for 25 years according to good clinical practice guidelines.
      At each trial-site the data flow will be monitored according to the GCP principles by a
      locally appointed external monitoring committee. After completion of statistical data
      analysis, data will be pseudo-anonymized and stored at the University of Alberta, Edmonton,
      Canada.

      Data protection The investigator(s) permits trial-related monitoring, audits, and regulatory
      inspection(s) by providing direct access to the source data and other relevant documents.
      Trial data will be handled according to regulations of the data protection agency in the
      respective countries.

      Quality assurance The trial will be carried out in accordance with the Declaration of
      Helsinki in its latest form and the International Conference on Harmonization Good Clinical
      Practice (ICH-GCP) guidelines.

      Monitoring The chief investigator consents to data evaluation being performed by the person
      in charge of monitoring in accordance with the monitoring plan, in order to ensure
      satisfactory data collection and adherence to the study protocol. Furthermore, the chief
      investigator states that he/she is willing to cooperate with this person and shall provide
      this person with all required information whenever necessary. This includes access to all
      documents related to the trial, including study-relevant medical files of patients in
      original form. The tasks of the investigator include maintenance of these patients' medical
      files as comprehensively as possible; this includes information concerning medical history,
      accompanying diseases, inclusion in the trial, data about visits, results of investigations,
      dispensing of medication, and adverse events. The monitor will also be permitted to perform
      data evaluation and draw comparisons with the relevant medical files in accordance with the
      standard operating procedures and ICH-GCP guidelines at predetermined intervals, in order to
      ensure adherence to the study protocol and continuous registration of data. All original
      medical reports required as sources for the information given in the CRF or the database
      shall be inspected. The study participants will have given their consent to such inspection
      by signing the consent form. The person in charge of monitoring is obliged to treat all
      information as confidential and to preserve the basic claims of the study participants in
      respect of integrity and protection of their privacy.
    

Intervention name(s): CC+SI; 3:1 C:V
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chest Compression; Newborn; Infant; Sustained Inflation