Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

Infant, Premature Clinical Trial

— HEART  

Official title:

Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133663
• Other study ID #: 092016-048
• Status: Completed
• Phase: N/A
• Start date: June 13, 2017
• Est. completion date: March 23, 2018

Study information

• Verified date: December 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 23, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature
• Neonatal Resuscitation

Intervention

Other:
• Electrocardiogram group
Experimental
• Pulse oximeter and auscultation group
Control

Locations

Country	Name	City	State
United States	Parkland Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to heart rate >100 beats per minute	Time in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Time to goal oxygen saturation	Time in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Time of positive pressure ventilation	Total time positive pressure received in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Incidence of positive pressure ventilation	Positive pressure ventilation applied in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Incidence of CPR	CRP applied in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Incidence of intubation	Intubation in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Maximum FiO2 applied	FiO2 applied in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Maximum peak inspiratory pressure	Maximum peak inspiratory pressure in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Incidence of hypothermia	Hypothermia on admission to NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of need for surfactant	Surfactant given while in NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of bronchopulmonary dysplasia	Incidence in NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of respiratory distress syndrome	Incidence in NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of pneumothorax	Incidence in NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of intraventricular hemorrhage	Incidence in NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of necrotizing enterocolitis	Incidence in NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of sepsis	Incidence in NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of symptomatic PDA	Incidence in NICU	Until hospital discharge, up to 6 months
Secondary	Incidence of appropriate vs inappropriate use of positive pressure ventilation	Use in delivery room	During delivery room resuscitation, up to 1 hour
Secondary	Incidence of equipment failure of pulse oximeter and electrocardiogram	Failure in delivery room	During delivery room resuscitation, up to 1 hour