Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates (HEART)

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Resuscitation; Infant, Premature
• Intervention / Treatment: Other: Pulse oximeter and auscultation group; Other: Electrocardiogram group

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 hour (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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; Control
Experimental: Electrocardiogram group; 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; Experimental

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2017
• Primary Completion (Actual): March 23, 2018
• Study Completion (Actual): March 23, 2018

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: premature; electrocardiogram; resuscitation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 092016-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No