Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC

NCT03902652 | Withdrawn DMC

• 1 other identifier: Pro00088541
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

When newborn babies are born without a heartbeat the clinical team has to provide breathing and chest compressions (what is call cardiopulmonary resuscitation) to the newborn baby. Cardiopulmonary resuscitation is an infrequent event in newborn babies (\~1% of all deliveries), approximately one million newborn babies die annually due to lack of oxygen at birth causing being born without a heartbeat. Outcome studies of newborn babies receiving cardiopulmonary resuscitation in the delivery room have reported high rates of death and neurological impairment. This puts a heavy burden on health resources since these infants require frequent hospital re-admission and long-term care. The poor prognosis raises questions as improve cardiopulmonary resuscitation methods and specifically adapt them to newborn babies to improve outcomes. Currently a 3:1 ratio, which equals 3 chest compressions to one rescue breath to resuscitate a newborn baby. This means that chest compressions are stopped after every 3rd compression to give one rescue breath. The investigators believe that this interruption of chest compressions is bad for the newborn baby and that chest compressions should be continued without interruption while rescue breaths are given continuously. The investigators believe that this approach will allow us to reduce death and long-term burdens in newborn babies born without a heartbeat. Furthermore, it is not known if rescue breaths given with 100% oxygen or 21% oxygen (room air) is better for newborn babies. Using continuous chest compressions and rescue breaths without interruptions, this study will compare 21% with 100% oxygen.

Conditions

Heart; Arrest, Newborn; Birth Asphyxia; Bradycardia Neonatal

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 (3)

• Mortality

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

• Number of Epinephrine dosses during resuscitation

  During resuscitation (up to 60 minutes)

• Rate of brain injury

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

Study Arms (2)

Intervention (21% oxygen during CC+SI)

EXPERIMENTAL

Infants randomized into the "21% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains \<60/min continue with CC+SI. During CC+SI the clinical team will only use 21% oxygen.

Procedure: Intervention (21% oxygen during CC+SI)

Intervention (100% oxygen during CC+SI)

ACTIVE COMPARATOR

Infants randomized into the "100% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains \<60/min continue with CC+SI. During CC+SI the clinical team will only use 100% oxygen.

Procedure: Intervention (100% oxygen during CC+SI)

Interventions

Intervention (21% oxygen during CC+SI) PROCEDURE

Infants randomized into the "21% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains \<60/min continue with CC+SI. During CC+SI the clinical team will only use 21% oxygen.

Intervention (21% oxygen during CC+SI)

Intervention (100% oxygen during CC+SI) PROCEDURE

Infants randomized into the "100% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains \<60/min continue with CC+SI. During CC+SI the clinical team will only use 100% oxygen.

Intervention (100% oxygen during CC+SI)

Eligibility Criteria

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

You may qualify if:

• Term infants requiring chest compressions in the delivery room
• Preterm infants \>28 weeks' gestation requiring chest compressions in the delivery room

You may not qualify if:

• Infants with congenital abnormality
• Infants with congenital diaphragmatic hernia or congenital heart disease
• Infants who's parents refused to give consent to this study

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Canada

Location

MeSH Terms

Conditions

Heart Arrest; Asphyxia Neonatorum

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Georg Schmolzer, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

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: April 2, 2019
• First Posted: April 4, 2019
• Study Start: August 27, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 26, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after publication

Locations

CA (1)