Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

Not Applicable

Completed

• Conditions: Infant, Premature; Neonatal Resuscitation
• Interventions: Other: Electrocardiogram group; Other: Pulse oximeter and auscultation group

• Registration Number: NCT03133663
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-22
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Study Start: 2017-06-13
• Primary Completion: 2018-03-23
• Study Completion: 2018-03-23
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of need for surfactant	Until hospital discharge, up to 6 months	Surfactant given while in NICU
Incidence of hypothermia	Until hospital discharge, up to 6 months	Hypothermia on admission to NICU
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
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 necrotizing enterocolitis	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
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 bronchopulmonary dysplasia	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 sepsis	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 symptomatic PDA	Until hospital discharge, up to 6 months	Incidence in NICU
Incidence of equipment failure of pulse oximeter and electrocardiogram	During delivery room resuscitation, up to 1 hour	Failure in delivery room

Trial Locations

Locations (1)

Parkland Hospital; 🇺🇸 Dallas, Texas, United States