Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03133663
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2017-04-22
Brief Title:
Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEART
Brief Summary:
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 ie achieve HR 100 beats per minute and oxygen saturation in goal range faster
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None