Trial Outcomes & Findings for SI + CC Versus 3:1 C:V Ratio During Neonatal CPR (NCT NCT02858583)

NCT ID: NCT02858583

Last Updated: 2024-08-29

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: up to 60 Minutes of chest compression
• Results posted on: 2024-08-29

Participant Flow

Participant milestones

Measure	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. 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 for a max of 5 minutes, when the team has to switch to 3:1 C:V.	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. 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.
Overall Study STARTED	12	15
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	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. 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 for a max of 5 minutes, when the team has to switch to 3:1 C:V.	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. 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.
Overall Study Declined consent	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention (CC+SI) n=11 Participants 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. 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.	Control (3:1 C:V) n=14 Participants 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. 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.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=11 Participants	14 Participants n=14 Participants	25 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=11 Participants	0 Participants n=14 Participants	0 Participants n=25 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants	0 Participants n=14 Participants	0 Participants n=25 Participants
Sex: Female, Male Female	4 Participants n=11 Participants	7 Participants n=14 Participants	11 Participants n=25 Participants
Sex: Female, Male Male	7 Participants n=11 Participants	7 Participants n=14 Participants	14 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: up to 60 Minutes of chest compression

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

Outcome measures

Measure	Intervention (CC+SI) n=11 Participants 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. 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 for a max of 5 minutes, when the team has to switch to 3:1 C:V.	Control (3:1 C:V) n=14 Participants 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. 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.
Return of Spontaneous Circulation	90 seconds Interval 60.0 to 270.0	615 seconds Interval 174.0 to 780.0

SECONDARY outcome

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

Number of infants who die until discharge - comparison between group

Outcome measures

Measure	Intervention (CC+SI) n=11 Participants 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. 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 for a max of 5 minutes, when the team has to switch to 3:1 C:V.	Control (3:1 C:V) n=14 Participants 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. 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.
Mortality	2 Participants	8 Participants

SECONDARY outcome

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

Brain injury either by ultrasound or magnet resonance imaging - comparison between group

Outcome measures

Measure	Intervention (CC+SI) n=11 Participants 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. 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 for a max of 5 minutes, when the team has to switch to 3:1 C:V.	Control (3:1 C:V) n=14 Participants 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. 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.
Rate of Brain Injury - Intraventricular Hemorrhage	1 Participants	2 Participants

SECONDARY outcome

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

Number of infants who develop Necrotizing enterocolitis - comparison between group

Outcome measures

Measure	Intervention (CC+SI) n=11 Participants 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. 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 for a max of 5 minutes, when the team has to switch to 3:1 C:V.	Control (3:1 C:V) n=14 Participants 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. 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.
Necrotizing Enterocolitis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: during resuscitation at birth

Epinephrine Doses via Umbilical venous catheter

Outcome measures

Measure	Intervention (CC+SI) n=11 Participants 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. 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 for a max of 5 minutes, when the team has to switch to 3:1 C:V.	Control (3:1 C:V) n=14 Participants 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. 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.
Epinephrine Doses Via Umbilical Venous Catheter	2.3 Doses Standard Deviation 1.5	2 Doses Standard Deviation 1.4

Adverse Events

Intervention (CC+SI)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Control (3:1 C:V)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Measure	Intervention (CC+SI) n=11 participants at risk 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. 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 for a max of 5 minutes, when the team has to switch to 3:1 C:V.	Control (3:1 C:V) n=14 participants at risk 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. 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	9.1% 1/11 • Number of events 1 • Until infant is discharge from hospital (maximum of 30 weeks after birth)	14.3% 2/14 • Number of events 2 • Until infant is discharge from hospital (maximum of 30 weeks after birth)
Nervous system disorders intraventricular hemorrhage	9.1% 1/11 • Number of events 1 • Until infant is discharge from hospital (maximum of 30 weeks after birth)	14.3% 2/14 • Number of events 2 • Until infant is discharge from hospital (maximum of 30 weeks after birth)

Other adverse events

Adverse event data not reported

Additional Information

Georg Schmölzer

University of Alberta

Phone: 780-735-4647

Email: schmolze@ualberta.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place