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

Primary Purpose

Neonatal Resuscitation, Infant, Premature

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrocardiogram group
Pulse oximeter and auscultation group
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neonatal Resuscitation focused on measuring electrocardiogram, premature, resuscitation

Eligibility Criteria

undefined - 1 Hour (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Electrocardiogram group

Arm Description

Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation.

Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Time to heart rate >100 beats per minute
Time in delivery room
Time to goal oxygen saturation
Time in delivery room
Time of positive pressure ventilation
Total time positive pressure received in delivery room
Incidence of positive pressure ventilation
Positive pressure ventilation applied in delivery room
Incidence of CPR
CRP applied in delivery room
Incidence of intubation
Intubation in delivery room
Maximum FiO2 applied
FiO2 applied in delivery room
Maximum peak inspiratory pressure
Maximum peak inspiratory pressure in delivery room
Incidence of hypothermia
Hypothermia on admission to NICU
Incidence of need for surfactant
Surfactant given while in NICU
Incidence of bronchopulmonary dysplasia
Incidence in NICU
Incidence of respiratory distress syndrome
Incidence in NICU
Incidence of pneumothorax
Incidence in NICU
Incidence of intraventricular hemorrhage
Incidence in NICU
Incidence of necrotizing enterocolitis
Incidence in NICU
Incidence of sepsis
Incidence in NICU
Incidence of symptomatic PDA
Incidence in NICU
Incidence of appropriate vs inappropriate use of positive pressure ventilation
Use in delivery room
Incidence of equipment failure of pulse oximeter and electrocardiogram
Failure in delivery room

Full Information

First Posted
April 22, 2017
Last Updated
December 19, 2018
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03133663
Brief Title
Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
Acronym
HEART
Official Title
Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
March 23, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Resuscitation, Infant, Premature
Keywords
electrocardiogram, premature, resuscitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation.
Arm Title
Electrocardiogram group
Arm Type
Experimental
Arm Description
Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.
Intervention Type
Other
Intervention Name(s)
Electrocardiogram group
Intervention Description
Experimental
Intervention Type
Other
Intervention Name(s)
Pulse oximeter and auscultation group
Intervention Description
Control
Primary Outcome Measure Information:
Title
Time to Infant Stabilization
Description
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)
Time Frame
During delivery room resuscitation, up to 1 hour
Secondary Outcome Measure Information:
Title
Time to heart rate >100 beats per minute
Description
Time in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Time to goal oxygen saturation
Description
Time in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Time of positive pressure ventilation
Description
Total time positive pressure received in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Incidence of positive pressure ventilation
Description
Positive pressure ventilation applied in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Incidence of CPR
Description
CRP applied in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Incidence of intubation
Description
Intubation in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Maximum FiO2 applied
Description
FiO2 applied in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Maximum peak inspiratory pressure
Description
Maximum peak inspiratory pressure in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Incidence of hypothermia
Description
Hypothermia on admission to NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of need for surfactant
Description
Surfactant given while in NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of bronchopulmonary dysplasia
Description
Incidence in NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of respiratory distress syndrome
Description
Incidence in NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of pneumothorax
Description
Incidence in NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of intraventricular hemorrhage
Description
Incidence in NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of necrotizing enterocolitis
Description
Incidence in NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of sepsis
Description
Incidence in NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of symptomatic PDA
Description
Incidence in NICU
Time Frame
Until hospital discharge, up to 6 months
Title
Incidence of appropriate vs inappropriate use of positive pressure ventilation
Description
Use in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour
Title
Incidence of equipment failure of pulse oximeter and electrocardiogram
Description
Failure in delivery room
Time Frame
During delivery room resuscitation, up to 1 hour

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Hour
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

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