NCT03133663

Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 1 Hour
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Resuscitation
• Infant, Premature

Interventions

Type	Name	Description
OTHER	Electrocardiogram group	Experimental
OTHER	Pulse oximeter and auscultation group	Control

Timeline

• Start date: 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 across 1 country: United States