Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
Completed · Not applicable
Conditions studied: Neonatal Resuscitation, Infant, Premature
In brief
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.
Key facts
- Study ID
- NCT03133663
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 51
- Starts
- 2017-06-13
- Expected to finish
- 2018-03-23
- Last updated by the study team
- 2018-12-21
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Parkland Hospital — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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