Newborn Infants Having Asystole or Bradycardia at Birth
Conditions
Keywords
Chest compression, Delivery Room, NICU,
Brief summary
Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.
Interventions
PROCEDURECC+SI
Chest compression will be superimposed by sustained inflation during CPR
PROCEDURE3:1 CPR
CPR using 3:1 ratio (control group)
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
Newborn infants with asystole Newborn infants with bradycardia
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Needed to Achieve Return of Spontaneous Circulation | within the first 10 minutes after birth | We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SI+CC Chest compression will be superimposed by sustained inflations during CPR:
CC+SI group Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.
CC+SI: Chest compression will be superimposed by sustained inflation during CPR | 5 |
| 3:1 CPR CPR using 3:1 C:V ratio:
3:1 C:V group Infants randomized into the 3:1 group requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.
3:1 CPR: CPR using 3:1 ratio (control group) | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | SI+CC | 3:1 CPR | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 1 / 5 | 4 / 4 |
Outcome results
Primary
Time Needed to Achieve Return of Spontaneous Circulation
We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique
Time frame: within the first 10 minutes after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SI+CC | Time Needed to Achieve Return of Spontaneous Circulation | 31 seconds | Standard Deviation 9 |
| 3:1 CPR | Time Needed to Achieve Return of Spontaneous Circulation | 138 seconds | Standard Deviation 72 |
Comparison: We hypothesised that during neonatal CPR, CC+SI will reduce the time needed to achieve ROSC. Our aim was to examine if CC+SI reduces ROSC compared with 3:1 C:V CPR in preterm infants \<33 weeks of gestation.~For this pilot study, based on the local incidence of CPR in preterm neonates, a convenient sample size of five patients per group was enrolled. Our primary outcome was time to achieve ROSC measured using ECG.p-value: 0.05t-test, 2 sided