PrematurityNCT01256346
Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination
An observational study of Prematurity, run by University of Oklahoma at 1 site in United States.
Trial summary
The goal of this study is to compare the time required for accurate heart rate measurement of the preterm newborn when using pulse oximetry versus electrocardiography leads. Read more about this study
- Who is it for?
- Ages Up to 20 minutes
- Conditions the study is for
- Prematurity
- What is being tested?
- Apparatuses
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2011
- Phase
- Observational
- 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 20 minutes
- All sexes
- No healthy volunteers
- Child
Study population: Thirty babies believed to be of 24-32 weeks gestational age who are to be born at the University of Oklahoma Health Sciences Center.
Who may be able to join
- Gestational age of 24-32 weeks
Who cannot join
- Babies with open abdominal defects
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Comparison of Electrocardiography Versus Pulse Oximetry for Determination of Initial Heart Rate in Preterm Newborns: A Pilot Study.
The goal of this study is to compare the time required for accurate heart rate measurement of the preterm newborn when using pulse oximetry versus electrocardiography leads.
- Conditions
- Prematurity
- Being tested
- Apparatuses
- Keywords
- Premature, baby, heart rate, 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.
ApparatusesDevice
Each baby will have both pulse oximetry leads (Massimo Radical 7) and electrocardiography leads (3M™ Red Dot™ Neonatal Limb Band Monitoring Electrodes, Pre-wired) applied. The time required for each modality to register a heart rate will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Babies | Preterm newborn infants thought to be 24-32 weeks gestational age. Receives: Device: Apparatuses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until accurate heart rate.
The elapsed time (in seconds) between application of the specific measuring apparatus (pulse oximeter probe or electrocardiograph leads) and measurement of heart rate.
Measured: To be determined
Secondary outcomes (1)
Intermeasurement accuracy
Assessment of the level of accuracy between the two times to be measured.
Measured: To be determined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Study completed by another institution prior to enrollment of first subject.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Dannaway, MD, University of Oklahoma
- Investigators
- Douglas Dannaway, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256346
- Sponsor's protocol ID
- OUHSC IRB 15458
- Status last verified
- Dec 2014
- First submitted
- 6 Dec 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6.
PubMed 18492509Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006 Dec;71(3):319-21. doi: 10.1016/j.resuscitation.2006.04.015. Epub 2006 Sep 20.
PubMed 16989935O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Feasibility of and delay in obtaining pulse oximetry during neonatal resuscitation. J Pediatr. 2005 Nov;147(5):698-9. doi: 10.1016/j.jpeds.2005.07.025.
PubMed 16291367Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002.
PubMed 15036740Petrozzino JJ, Heldt GP, Rich WD, Finer NN. Use of ECG for initial newborn heart rate assessment: a pilot/feasibility study. J Investig Med. 2008;56(1):263-7.
Vento M, Aguar M, Leone TA, Finer NN, Gimeno A, Rich W, Saenz P, Escrig R, Brugada M. Using intensive care technology in the delivery room: a new concept for the resuscitation of extremely preterm neonates. Pediatrics. 2008 Nov;122(5):1113-6. doi: 10.1542/peds.2008-1422. No abstract available.
PubMed 18977992
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Electrocardiography Versus Pulse Oximetry for Determination of Initial Heart Rate in Preterm Newborns: A Pilot Study.
- ClinicalTrials.gov ID
- NCT01256346
- Acronym / sponsor ID
- OUHSC IRB 15458
- Conditions
- Prematurity
- Keywords
- Premature, baby, heart rate, resuscitation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study completed by another institution prior to enrollment of first subject.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Dec 2010 (estimated)
- 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 goal of this study is to compare the time required for accurate heart rate measurement of the preterm newborn when using pulse oximetry versus electrocardiography leads.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babies | – | Device: ApparatusesPreterm newborn infants thought to be 24-32 weeks gestational age. |
Who may qualify
- Ages
- Up to 20 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Thirty babies believed to be of 24-32 weeks gestational age who are to be born at the University of Oklahoma Health Sciences Center.
Key inclusion criteria (1 listed)
- Gestational age of 24-32 weeks
Key exclusion criteria (1 listed)
- Babies with open abdominal defects
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 |
|---|---|---|
| ApparatusesEach baby will have both pulse oximetry leads (Massimo Radical 7) and electrocardiography leads (3M™ Red Dot™ Neonatal Limb Band Monitoring Electrodes, Pre-wired) applied. The time required for each modality to register a heart rate will be compared. | Device | Babies |
Primary outcome
Time until accurate heart rate.
Time frame: To be determined
The elapsed time (in seconds) between application of the specific measuring apparatus (pulse oximeter probe or electrocardiograph leads) and measurement of heart rate.
1 secondary outcome
Intermeasurement accuracy
Time frame: To be determined
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Results publication: PubMed 18492509Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6.
- Results publication: PubMed 16989935Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006 Dec;71(3):319-21. doi: 10.1016/j.resuscitation.2006.04.015. Epub 2006 Sep 20.
- Results publication: PubMed 16291367O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Feasibility of and delay in obtaining pulse oximetry during neonatal resuscitation. J Pediatr. 2005 Nov;147(5):698-9. doi: 10.1016/j.jpeds.2005.07.025.
- Results publication: PubMed 15036740Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002.
- Results publicationPetrozzino JJ, Heldt GP, Rich WD, Finer NN. Use of ECG for initial newborn heart rate assessment: a pilot/feasibility study. J Investig Med. 2008;56(1):263-7.
- Results publication: PubMed 18977992Vento M, Aguar M, Leone TA, Finer NN, Gimeno A, Rich W, Saenz P, Escrig R, Brugada M. Using intensive care technology in the delivery room: a new concept for the resuscitation of extremely preterm neonates. Pediatrics. 2008 Nov;122(5):1113-6. doi: 10.1542/peds.2008-1422. No abstract available.
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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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.
Douglas Dannaway, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, run by University of Oklahoma 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Dec 2014. 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 was withdrawn before enrolling participants, so there are no results.
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 until accurate heart rate. (time frame: To be determined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256346, which also lists 6 linked publications.
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 2 Dec 2014.