Clinical trial NCT04587934: Time to Accurate Heart Rate on Neonatal Outcomes
Official title: Time to Accurate Heart Rate on Neonatal Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Extremely Low Birth Weight
Extreme Prematurity
Keywords: electrocardiogram
Neonatal Resuscitation
resuscitation of premature infants
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: GE Healthcare
name: Sharp Mary Birch Hospital for Women & Newborns
First posted: 2020-10-14
Enrollment: 42
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation).

Detailed description: This is a prospective interventional randomized control trial. Infants born between 23+0 and 32+6 estimated gestational age will be randomized using a computer generate allocation sequence stratified by gestational age. Randomization cards will be placed in opaque envelopes. For the intervention group, the care team will use the Panda iRes Warmer with ResusView Bed during resuscitation interventions in the first 10 minutes of life. During use of the iRes-warmer, standard nursing care of an infant on a radiant warmer will be followed. Participants assigned to the control group will receive interventions using the same model Panda bed without ResusView. There is no minimum time for monitoring, and the maximum time depends on clinical determination for use of heart rate feature for each resuscitation event. Data including the infant's gestational age, Electrocardiogram lead type and activities that occurred during resuscitation will be recorded for the first 10 minutes of life.

Eligibility criteria: Inclusion Criteria:

* Infants who are delivered to mothers over the age of 16 years of age
* Infants delivered at 23+0 to 32+6 weeks estimated gestational age based on the best obstetric estimate at the time of delivery.
* Infants without known congenital malformations prior to delivery
* Antenatal consent

Exclusion Criteria:

* Infants who are delivered to mothers under the age of 16 years of age
* Known congenital anomalies of newborn prior to delivery
* Cardiac defects other than small Ventricular septum defect and Patent ductus arteriosus
* Multiples
* Declined consent
* iRes Warmer with ResusView not available at time of delivery

Primary outcomes:
measure: Time to Heart Rate Display in iRes Warmer With Resusview
timeFrame: Birth to 10 minutes of life
Secondary outcomes:
measure: Time to First Change in Fraction of Inspired Oxygen
timeFrame: Birth to 10 minutes of life
measure: Time to First Change in Airway Pressure
timeFrame: Birth to 10 minutes of life
measure: Time to Initiation of Positive Pressure Ventilation (PPV)
timeFrame: Birth to 10 minutes of life
Other outcomes:
measure: Time of Electrode Placement
timeFrame: Birth to 10 minutes of life
measure: EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation
timeFrame: Birth to 10 minutes of life
measure: Time to Rhythm Recognition
timeFrame: Birth to 10 minutes of life
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp HealthCare
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katheria A, Arnell K, Brown M, Hassen K, Maldonado M, Rich W, Finer N. A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One. 2017 Nov 3;12(11):e0187730. doi: 10.1371/journal.pone.0187730. eCollection 2017.
citation: Johnson PA, Schmolzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1):43. doi: 10.3390/healthcare8010043.
citation: Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.
citation: Katheria AC, Morales A, Shashank S, Rich WD, Finer NN. A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth. J Pediatr. 2022 Mar;242:245-247.e1. doi: 10.1016/j.jpeds.2021.10.037. Epub 2021 Oct 27.