Clinical trial NCT03133663: Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
Official title: Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Resuscitation
Infant, Premature
Keywords: electrocardiogram
premature
resuscitation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 51
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Infant Stabilization
timeFrame: During delivery room resuscitation, up to 1 hour
Secondary outcomes:
measure: Time to heart rate >100 beats per minute
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Time to goal oxygen saturation
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Time of positive pressure ventilation
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Incidence of positive pressure ventilation
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Incidence of CPR
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Incidence of intubation
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Maximum FiO2 applied
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Maximum peak inspiratory pressure
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Incidence of hypothermia
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of need for surfactant
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of bronchopulmonary dysplasia
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of respiratory distress syndrome
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of pneumothorax
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of intraventricular hemorrhage
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of necrotizing enterocolitis
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of sepsis
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of symptomatic PDA
timeFrame: Until hospital discharge, up to 6 months
measure: Incidence of appropriate vs inappropriate use of positive pressure ventilation
timeFrame: During delivery room resuscitation, up to 1 hour
measure: Incidence of equipment failure of pulse oximeter and electrocardiogram
timeFrame: During delivery room resuscitation, up to 1 hour
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
Study officials:
References: