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Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

NCT03133663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-12-21

No results posted yet for this study

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

OTHER

Electrocardiogram group

Experimental

OTHER

Pulse oximeter and auscultation group

Control

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Hour
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-13
Primary Completion
2018-03-23
Completion
2018-03-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03133663 on ClinicalTrials.gov