Neonatal ResuscitationHEARTNCT03133663
Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
A study testing Electrocardiogram group and Pulse oximeter and auscultation group in people with Neonatal Resuscitation and Infant, Premature, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 1 hour
- Conditions the study is for
- Neonatal Resuscitation, Infant, Premature
- What is being tested?
- Electrocardiogram group and Pulse oximeter and auscultation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 23 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 hour
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neonatal Resuscitation, Infant, Premature
- Being tested
- Electrocardiogram group, Pulse oximeter and auscultation group
- Keywords
- electrocardiogram, premature, resuscitation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram groupOther
Experimental
Pulse oximeter and auscultation groupOther
Control
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation. Receives: Other: Pulse oximeter and auscultation group |
| Electrocardiogram group | Experimental | Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation. Receives: Other: Electrocardiogram group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Infant Stabilization
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)
Measured: During delivery room resuscitation, up to 1 hour
Secondary outcomes (19)
Time to heart rate >100 beats per minute
Time in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Time to goal oxygen saturation
Time in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Time of positive pressure ventilation
Total time positive pressure received in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Incidence of positive pressure ventilation
Positive pressure ventilation applied in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Incidence of CPR
CRP applied in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Incidence of intubation
Intubation in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Maximum FiO2 applied
FiO2 applied in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Maximum peak inspiratory pressure
Maximum peak inspiratory pressure in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Incidence of hypothermia
Hypothermia on admission to NICU
Measured: Until hospital discharge, up to 6 months
Incidence of need for surfactant
Surfactant given while in NICU
Measured: Until hospital discharge, up to 6 months
Incidence of bronchopulmonary dysplasia
Incidence in NICU
Measured: Until hospital discharge, up to 6 months
Incidence of respiratory distress syndrome
Incidence in NICU
Measured: Until hospital discharge, up to 6 months
Incidence of pneumothorax
Incidence in NICU
Measured: Until hospital discharge, up to 6 months
Incidence of intraventricular hemorrhage
Incidence in NICU
Measured: Until hospital discharge, up to 6 months
Incidence of necrotizing enterocolitis
Incidence in NICU
Measured: Until hospital discharge, up to 6 months
Incidence of sepsis
Incidence in NICU
Measured: Until hospital discharge, up to 6 months
Incidence of symptomatic PDA
Incidence in NICU
Measured: Until hospital discharge, up to 6 months
Incidence of appropriate vs inappropriate use of positive pressure ventilation
Use in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Incidence of equipment failure of pulse oximeter and electrocardiogram
Failure in delivery room
Measured: During delivery room resuscitation, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start13 Jun 2017
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Kapadia, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133663
- Sponsor's protocol ID
- 092016-048
- Acronym
- HEART
- Status last verified
- Dec 2018
- First submitted
- 22 Apr 2017
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
- ClinicalTrials.gov ID
- NCT03133663
- Acronym / sponsor ID
- HEART / 092016-048
- Conditions
- Neonatal Resuscitation, Infant, Premature
- Keywords
- electrocardiogram, premature, resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Pulse oximeter and auscultation groupPulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation. |
| Electrocardiogram group | Experimental | Other: Electrocardiogram groupElectrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation. |
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiogram groupExperimental | Other | Electrocardiogram group |
| Pulse oximeter and auscultation groupControl | Other | Control group |
Primary outcome
Time to Infant Stabilization
Time frame: During delivery room resuscitation, up to 1 hour
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)
19 secondary outcomes
Time to heart rate >100 beats per minute
Time frame: During delivery room resuscitation, up to 1 hour
Time to goal oxygen saturation
Time frame: During delivery room resuscitation, up to 1 hour
Time of positive pressure ventilation
Time frame: During delivery room resuscitation, up to 1 hour
Incidence of positive pressure ventilation
Time frame: During delivery room resuscitation, up to 1 hour
Incidence of CPR
Time frame: During delivery room resuscitation, up to 1 hour
Incidence of intubation
Time frame: During delivery room resuscitation, up to 1 hour
Maximum FiO2 applied
Time frame: During delivery room resuscitation, up to 1 hour
Maximum peak inspiratory pressure
Time frame: During delivery room resuscitation, up to 1 hour
Incidence of hypothermia
Time frame: Until hospital discharge, up to 6 months
Incidence of need for surfactant
Time frame: Until hospital discharge, up to 6 months
Incidence of bronchopulmonary dysplasia
Time frame: Until hospital discharge, up to 6 months
Incidence of respiratory distress syndrome
Time frame: Until hospital discharge, up to 6 months
Incidence of pneumothorax
Time frame: Until hospital discharge, up to 6 months
Incidence of intraventricular hemorrhage
Time frame: Until hospital discharge, up to 6 months
Incidence of necrotizing enterocolitis
Time frame: Until hospital discharge, up to 6 months
Incidence of sepsis
Time frame: Until hospital discharge, up to 6 months
Incidence of symptomatic PDA
Time frame: Until hospital discharge, up to 6 months
Incidence of appropriate vs inappropriate use of positive pressure ventilation
Time frame: During delivery room resuscitation, up to 1 hour
Incidence of equipment failure of pulse oximeter and electrocardiogram
Time frame: During delivery room resuscitation, up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram group and Pulse oximeter and auscultation group in people with Neonatal Resuscitation and Infant, Premature, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Infant Stabilization (time frame: During delivery room resuscitation, up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.