Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-13

Study Completion Date

2018-03-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

NCT01256346

Prematurity

WITHDRAWN

ECG Monitoring During NRP: a False Sense of Security?

NCT03660033

Neonatal Resuscitation Simulation

UNKNOWN NA

Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants

NCT03655639

Premature Birth

ACTIVE_NOT_RECRUITING

HeartLight Pulse Study: Evaluation of Heart Rate Using an Electronic Stethoscope and Pre Placed ECG in the Delivery Room

NCT02747069

Premature Birth

SUSPENDED

Saturation Targets and Resuscitation in Preterm Trial

NCT03115463

Oxidative Stress

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neonatal Resuscitation Infant, Premature

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation.

Group Type ACTIVE_COMPARATOR

Pulse oximeter and auscultation group

Intervention Type OTHER

Control

Electrocardiogram group

Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.

Group Type EXPERIMENTAL

Electrocardiogram group

Intervention Type OTHER

Experimental

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electrocardiogram group

Experimental

Intervention Type OTHER

Pulse oximeter and auscultation group

Control

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No