Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

Study Overview
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Brief Summary
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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.

Official Title
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Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

Conditions
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Neonatal Resuscitation, Infant, Premature

Intervention / Treatment
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* Other: Electrocardiogram group
* Other: Pulse oximeter and auscultation group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation. | Other: Pulse oximeter and auscultation group<br>* Control<br>|
| Experimental: Electrocardiogram group<br>Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation. | Other: Electrocardiogram group<br>* Experimental<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Infant Stabilization | 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) | During delivery room resuscitation, up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to heart rate >100 beats per minute | Time in delivery room | During delivery room resuscitation, up to 1 hour | 
| Time to goal oxygen saturation | Time in delivery room | During delivery room resuscitation, up to 1 hour | 
| Time of positive pressure ventilation | Total time positive pressure received in delivery room | During delivery room resuscitation, up to 1 hour | 
| Incidence of positive pressure ventilation | Positive pressure ventilation applied in delivery room | During delivery room resuscitation, up to 1 hour | 
| Incidence of CPR | CRP applied in delivery room | During delivery room resuscitation, up to 1 hour | 
| Incidence of intubation | Intubation in delivery room | During delivery room resuscitation, up to 1 hour | 
| Maximum FiO2 applied | FiO2 applied in delivery room | During delivery room resuscitation, up to 1 hour | 
| Maximum peak inspiratory pressure | Maximum peak inspiratory pressure in delivery room | During delivery room resuscitation, up to 1 hour | 
| Incidence of hypothermia | Hypothermia on admission to NICU | Until hospital discharge, up to 6 months | 
| Incidence of need for surfactant | Surfactant given while in NICU | Until hospital discharge, up to 6 months | 
| Incidence of bronchopulmonary dysplasia | Incidence in NICU | Until hospital discharge, up to 6 months | 
| Incidence of respiratory distress syndrome | Incidence in NICU | Until hospital discharge, up to 6 months | 
| Incidence of pneumothorax | Incidence in NICU | Until hospital discharge, up to 6 months | 
| Incidence of intraventricular hemorrhage | Incidence in NICU | Until hospital discharge, up to 6 months | 
| Incidence of necrotizing enterocolitis | Incidence in NICU | Until hospital discharge, up to 6 months | 
| Incidence of sepsis | Incidence in NICU | Until hospital discharge, up to 6 months | 
| Incidence of symptomatic PDA | Incidence in NICU | Until hospital discharge, up to 6 months | 
| Incidence of appropriate vs inappropriate use of positive pressure ventilation | Use in delivery room | During delivery room resuscitation, up to 1 hour | 
| Incidence of equipment failure of pulse oximeter and electrocardiogram | Failure in delivery room | During delivery room resuscitation, up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature, electrocardiogram, resuscitation