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Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates

NCT ID: NCT03133663

Last Updated: 2018-12-21

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

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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

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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.

Detailed Description

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Conditions

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Neonatal Resuscitation Infant, Premature

Keywords

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electrocardiogram premature resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

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Electrocardiogram group

Experimental

Intervention Type OTHER

Pulse oximeter and auscultation group

Control

Intervention Type OTHER

Eligibility Criteria

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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

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Vishal Kapadia

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Parkland Hospital

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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092016-048

Identifier Type: -

Identifier Source: org_study_id