Parkland Hospital
Dallas, Texas, 75235, United States
NCT Number: NCT03133663
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.
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Notify MeUp to 1 hour
All sexes
Interventional
Not applicable
Dallas, Texas, 75235, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Experimental
Control
Time frame: During delivery room resuscitation, up to 1 hour
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)
Time frame: During delivery room resuscitation, up to 1 hour
Time in delivery room
Time frame: During delivery room resuscitation, up to 1 hour
Time in delivery room
Time frame: During delivery room resuscitation, up to 1 hour
Total time positive pressure received in delivery room
Time frame: During delivery room resuscitation, up to 1 hour
Positive pressure ventilation applied in delivery room
Time frame: During delivery room resuscitation, up to 1 hour
CRP applied in delivery room
Time frame: During delivery room resuscitation, up to 1 hour
Intubation in delivery room
Time frame: During delivery room resuscitation, up to 1 hour
FiO2 applied in delivery room
Time frame: During delivery room resuscitation, up to 1 hour
Maximum peak inspiratory pressure in delivery room
Time frame: Until hospital discharge, up to 6 months
Hypothermia on admission to NICU
Time frame: Until hospital discharge, up to 6 months
Surfactant given while in NICU
Time frame: Until hospital discharge, up to 6 months
Incidence in NICU
Time frame: Until hospital discharge, up to 6 months
Incidence in NICU
Time frame: Until hospital discharge, up to 6 months
Incidence in NICU
Time frame: Until hospital discharge, up to 6 months
Incidence in NICU
Time frame: Until hospital discharge, up to 6 months
Incidence in NICU
Time frame: Until hospital discharge, up to 6 months
Incidence in NICU
Time frame: Until hospital discharge, up to 6 months
Incidence in NICU
Time frame: During delivery room resuscitation, up to 1 hour
Use in delivery room
Time frame: During delivery room resuscitation, up to 1 hour
Failure in delivery room
University of Texas Southwestern Medical Center
Other
Acronym: HEART
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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