NCT03133663: HEART

Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

Completed NA Last updated 21 December 2018

What this trial tests

NA trial testing Electrocardiogram group in Neonatal Resuscitation in 51 participants. Completed in 23 March 2018.

Timeline

13 June 2017

Primary endpoint
23 March 2018

23 March 2018

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	51
Start date	13 June 2017
Primary completion	23 March 2018
Estimated completion	23 March 2018
Sites	1 location across United States

Drugs / interventions tested

• Electrocardiogram group
• Pulse oximeter and auscultation group

Conditions studied

• Neonatal Resuscitation — all drugs for Neonatal Resuscitation →
• Infant, Premature — all drugs for Infant, Premature →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Under 1 Hour, any sex, with Neonatal Resuscitation or Infant, Premature. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Electrocardiogram for heart rate evaluation during preterm resuscitation at birth: a randomized trial.
   Abbey NV, Mashruwala V, Weydig HM, Steven Brown L, et al · · 2022 · cited 19× · PMID 34645954 · DOI 10.1038/s41390-021-01731-z