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Completed

NCT Number: NCT03133663

Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

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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Key information

Age range

Up to 1 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Hospital

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrocardiogram group

Other

Experimental

Pulse oximeter and auscultation group

Other

Control

Primary outcomes

  1. Time to Infant Stabilization

    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)

Secondary outcomes

  1. Time to heart rate >100 beats per minute

    Time frame: During delivery room resuscitation, up to 1 hour

    Time in delivery room

  2. Time to goal oxygen saturation

    Time frame: During delivery room resuscitation, up to 1 hour

    Time in delivery room

  3. Time of positive pressure ventilation

    Time frame: During delivery room resuscitation, up to 1 hour

    Total time positive pressure received in delivery room

  4. Incidence of positive pressure ventilation

    Time frame: During delivery room resuscitation, up to 1 hour

    Positive pressure ventilation applied in delivery room

  5. Incidence of CPR

    Time frame: During delivery room resuscitation, up to 1 hour

    CRP applied in delivery room

  6. Incidence of intubation

    Time frame: During delivery room resuscitation, up to 1 hour

    Intubation in delivery room

  7. Maximum FiO2 applied

    Time frame: During delivery room resuscitation, up to 1 hour

    FiO2 applied in delivery room

  8. Maximum peak inspiratory pressure

    Time frame: During delivery room resuscitation, up to 1 hour

    Maximum peak inspiratory pressure in delivery room

  9. Incidence of hypothermia

    Time frame: Until hospital discharge, up to 6 months

    Hypothermia on admission to NICU

  10. Incidence of need for surfactant

    Time frame: Until hospital discharge, up to 6 months

    Surfactant given while in NICU

  11. Incidence of bronchopulmonary dysplasia

    Time frame: Until hospital discharge, up to 6 months

    Incidence in NICU

  12. Incidence of respiratory distress syndrome

    Time frame: Until hospital discharge, up to 6 months

    Incidence in NICU

  13. Incidence of pneumothorax

    Time frame: Until hospital discharge, up to 6 months

    Incidence in NICU

  14. Incidence of intraventricular hemorrhage

    Time frame: Until hospital discharge, up to 6 months

    Incidence in NICU

  15. Incidence of necrotizing enterocolitis

    Time frame: Until hospital discharge, up to 6 months

    Incidence in NICU

  16. Incidence of sepsis

    Time frame: Until hospital discharge, up to 6 months

    Incidence in NICU

  17. Incidence of symptomatic PDA

    Time frame: Until hospital discharge, up to 6 months

    Incidence in NICU

  18. Incidence of appropriate vs inappropriate use of positive pressure ventilation

    Time frame: During delivery room resuscitation, up to 1 hour

    Use in delivery room

  19. Incidence of equipment failure of pulse oximeter and electrocardiogram

    Time frame: During delivery room resuscitation, up to 1 hour

    Failure in delivery room

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: HEART

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2017
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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