Infant, Premature, Neonatal Resuscitation
Conditions
Keywords
electrocardiogram, premature, resuscitation
Brief summary
The purpose of this study is to determine whether using electrocardiograms (ECGs) during resuscitation of preterm infants (less than 31 weeks gestation) will decrease the amount of time it takes from birth for heart rate (HR) to be above 100 beats per minute and oxygen saturations to be in the goal range, in other words to stabilize the infant. A few studies have been conducted which showed that ECGs are faster at detecting HR than pulse oximetry (PO). Sample sizes, however, have been small and only few extremely low birthweight infants have been included. It is unclear if use of ECG in these tiny preterm infants in addition to traditional techniques to determine HR will be beneficial and impact resuscitation and outcomes. The investigators propose a study where infants will be randomized to either using ECG in addition to PO ± auscultation versus PO ± auscultation only to assess HR during neonatal resuscitation. The investigators hypothesize that the group of infants randomized to ECG will be able to stabilize faster, i.e. achieve HR \> 100 beats per minute and oxygen saturation in goal range faster.
Interventions
OTHERElectrocardiogram group
Experimental
OTHERPulse oximeter and auscultation group
Control
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Hours
Healthy volunteers
No
Inclusion criteria
* Preterm infants less than \<31 weeks gestation born at Parkland hospital vaginally or by C/S * Infant with congenital heart disease, congenital anomalies, or chromosomal abnormalities will be included unless comfort care has been agreed upon beforehand * Resuscitation team present to attend delivery before birth
Exclusion criteria
* Any infant with prenatally agreed upon comfort care since resuscitation will not be provided * Any precipitous delivery since resuscitation team will not be in attendance prior to delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Infant Stabilization | During delivery room resuscitation, up to 1 hour | Amount of time it takes from birth for heart rate to be above 100 beats per minute and oxygen saturation to be in the goal range (per Neonatal Resuscitation Program guidelines) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to goal oxygen saturation | During delivery room resuscitation, up to 1 hour | Time in delivery room |
| Time of positive pressure ventilation | During delivery room resuscitation, up to 1 hour | Total time positive pressure received in delivery room |
| Incidence of positive pressure ventilation | During delivery room resuscitation, up to 1 hour | Positive pressure ventilation applied in delivery room |
| Incidence of CPR | During delivery room resuscitation, up to 1 hour | CRP applied in delivery room |
| Incidence of intubation | During delivery room resuscitation, up to 1 hour | Intubation in delivery room |
| Maximum FiO2 applied | During delivery room resuscitation, up to 1 hour | FiO2 applied in delivery room |
| Maximum peak inspiratory pressure | During delivery room resuscitation, up to 1 hour | Maximum peak inspiratory pressure in delivery room |
| Incidence of bronchopulmonary dysplasia | Until hospital discharge, up to 6 months | Incidence in NICU |
| Incidence of respiratory distress syndrome | Until hospital discharge, up to 6 months | Incidence in NICU |
| Time to heart rate >100 beats per minute | During delivery room resuscitation, up to 1 hour | Time in delivery room |
| Incidence of need for surfactant | Until hospital discharge, up to 6 months | Surfactant given while in NICU |
| Incidence of pneumothorax | Until hospital discharge, up to 6 months | Incidence in NICU |
| Incidence of intraventricular hemorrhage | Until hospital discharge, up to 6 months | Incidence in NICU |
| Incidence of necrotizing enterocolitis | Until hospital discharge, up to 6 months | Incidence in NICU |
| Incidence of sepsis | Until hospital discharge, up to 6 months | Incidence in NICU |
| Incidence of symptomatic PDA | Until hospital discharge, up to 6 months | Incidence in NICU |
| Incidence of appropriate vs inappropriate use of positive pressure ventilation | During delivery room resuscitation, up to 1 hour | Use in delivery room |
| Incidence of equipment failure of pulse oximeter and electrocardiogram | During delivery room resuscitation, up to 1 hour | Failure in delivery room |
| Incidence of hypothermia | Until hospital discharge, up to 6 months | Hypothermia on admission to NICU |
Countries
United States
Outcome results
None listed