Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Time to Infant Stabilization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- — to 1 Hour (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Control group
Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation.
Intervention: Pulse oximeter and auscultation group (Other)
Electrocardiogram group
Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.
Intervention: Electrocardiogram group (Other)
Outcomes
Primary Outcomes
Time to Infant Stabilization
Time Frame: 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 Outcomes
- Incidence of CPR(During delivery room resuscitation, up to 1 hour)
- Incidence of intubation(During delivery room resuscitation, up to 1 hour)
- Incidence of hypothermia(Until hospital discharge, up to 6 months)
- Time to heart rate >100 beats per minute(During delivery room resuscitation, up to 1 hour)
- Time to goal oxygen saturation(During delivery room resuscitation, up to 1 hour)
- Time of positive pressure ventilation(During delivery room resuscitation, up to 1 hour)
- Incidence of positive pressure ventilation(During delivery room resuscitation, up to 1 hour)
- Incidence of necrotizing enterocolitis(Until hospital discharge, up to 6 months)
- Incidence of respiratory distress syndrome(Until hospital discharge, up to 6 months)
- Maximum FiO2 applied(During delivery room resuscitation, up to 1 hour)
- Maximum peak inspiratory pressure(During delivery room resuscitation, up to 1 hour)
- Incidence of need for surfactant(Until hospital discharge, up to 6 months)
- Incidence of bronchopulmonary dysplasia(Until hospital discharge, up to 6 months)
- Incidence of pneumothorax(Until hospital discharge, up to 6 months)
- Incidence of intraventricular hemorrhage(Until hospital discharge, up to 6 months)
- Incidence of sepsis(Until hospital discharge, up to 6 months)
- Incidence of appropriate vs inappropriate use of positive pressure ventilation(During delivery room resuscitation, up to 1 hour)
- Incidence of symptomatic PDA(Until hospital discharge, up to 6 months)
- Incidence of equipment failure of pulse oximeter and electrocardiogram(During delivery room resuscitation, up to 1 hour)
Investigators
Vishal Kapadia
Assistant Professor of Pediatrics
University of Texas Southwestern Medical Center