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NCT03133663 · ClinicalTrials.gov registry record · NA
Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT03133663: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT03133663 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03133663, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study 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, i.e. achieve HR \> 100 beats per minute and oxygen saturation in goal range faster.
Primary Outcome
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)
Interventions
- OTHER Electrocardiogram group
- OTHER Pulse oximeter and auscultation group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-06-13 |
| Est. Completion | 2018-03-23 |
| Phase | NA |
What the finished NCT03133663 record still lists
NCT03133663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Electrocardiogram group is the first listed.
NCT03133663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03133663 about?
NCT03133663 is a clinical study titled "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 ...
What is the current status of trial NCT03133663?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2017-06-13. Estimated completion is 2018-03-23.
What interventions are being tested in trial NCT03133663?
The interventions under investigation include: Electrocardiogram group (OTHER), Pulse oximeter and auscultation group (OTHER).
Who is sponsoring clinical trial NCT03133663?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03133663's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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