Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

NCT03133663 — Not applicable, Completed, 51 participants, University of Texas Southwestern Medical Center

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Registry	NCT03133663, acronym HEART
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	51 (Actual)
Sponsor	University of Texas Southwestern Medical Center (Other)
Conditions	Neonatal Resuscitation, Infant, Premature
Interventions	Electrocardiogram group, Pulse oximeter and auscultation group (Other)
Dates	start 2017-06-13, primary completion 2018-03-23, completion 2018-03-23, first posted 2017-04-28, last updated 2018-12-21
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Control group	Active comparator	Other: Pulse oximeter and auscultation group	Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation.
Electrocardiogram group	Experimental	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.

Electrocardiogram group (Other): Experimental
Pulse oximeter and auscultation group (Other): Control

+Outcome measures

Primary outcomes

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 outcomes

Time to heart rate >100 beats per minute [During delivery room resuscitation, up to 1 hour]: Time in delivery room
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 hypothermia [Until hospital discharge, up to 6 months]: Hypothermia on admission to NICU
Incidence of need for surfactant [Until hospital discharge, up to 6 months]: Surfactant given while in NICU
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
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

+Eligibility

Sex: All, ages: any to 1 Hour

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

+Locations (1)

Facility	City	Country	Status
Parkland Hospital	Dallas, Texas	United States

My Notes

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