Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

NCT03133663 | Completed

• 1 other identifier: 092016-048
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Resuscitation; Infant, Premature

Keywords

electrocardiogram; premature; resuscitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Time to heart rate >100 beats per minute

  During delivery room resuscitation, up to 1 hour

• Time to goal oxygen saturation

  During delivery room resuscitation, up to 1 hour

• Time of positive pressure ventilation

  During delivery room resuscitation, up to 1 hour

• Incidence of positive pressure ventilation

  During delivery room resuscitation, up to 1 hour

• Incidence of CPR

  During delivery room resuscitation, up to 1 hour

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Electrocardiogram group

EXPERIMENTAL

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

Interventions

Electrocardiogram group OTHER

Experimental

Electrocardiogram group

Pulse oximeter and auscultation group OTHER

Control

Control group

Eligibility Criteria

• Age: Up to 1 Hour
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: April 22, 2017
• First Posted: April 28, 2017
• Study Start: June 13, 2017
• Primary Completion: March 23, 2018
• Study Completion: March 23, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)