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

The University of Texas System (UT)

Status: Completed

Conditions: Infant, Premature; Neonatal Resuscitation

Treatments: Other: Electrocardiogram group; Other: Pulse oximeter and auscultation group

Study type: Interventional

Funder types: Other

Identifiers

NCT03133663

092016-048

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: Under 1 hour old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

51 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Other: Pulse oximeter and auscultation group

Electrocardiogram group

Experimental group

Description:

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

Treatment:

Other: Electrocardiogram group