Cardiac Output, LowNCT02195037
Changes in Cardiac Output During Delayed Umbilical Cord Clamping
An observational study of Cardiac Output, Low, run by Sharp HealthCare at 1 site in United States.
Trial summary
Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. Read more about this study
- Who is it for?
- Ages Up to 1 minute
- Conditions the study is for
- Cardiac Output, Low
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2014
- 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 1 minute
- All sexes
- No healthy volunteers
- Child
Study population: Healthy full term infants delivered by vaginal birth with an estimated gestational age of 37+1 to 41+6 weeks corrected gestational age
Who may be able to join
- Healthy full term infants
- Delivered by vaginal birth
- Estimated gestational age of 37+0to 41+6 weeks corrected gestational age
Who cannot join
- Multiples
- Known fetal anomalies (including cardiac defects).
- Instrumentation during delivery (forceps or vacuum)
- Non-reducible nuchal cord during delivery.
- Any maternal or neonatal indication requiring immediate cord clamping.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
About this study
Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. The purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition
- Conditions
- Cardiac Output, Low
- Keywords
- Delayed Cord Clamping
- Medical subject headings
- Cardiac Output, Low
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Measured: 5 minutes of Life
Secondary outcomes (3)
Stroke Volume
Measured: 5 Minutes of Life
Bilirubin level
Measured: until discharge
Hemoglobin level
Measured: until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anup Katheria, M.D., Sharp HealthCare
- Investigators
- Anup Katheria, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195037
- Sponsor's protocol ID
- CO-DCC
- Status last verified
- Aug 2014
- First submitted
- 17 Jul 2014
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015.
PubMed 27057332
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cardiac Output During Delayed Umbilical Cord Clamping
- ClinicalTrials.gov ID
- NCT02195037
- Acronym / sponsor ID
- CO-DCC
- Conditions
- Cardiac Output, Low
- Keywords
- Delayed Cord Clamping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jul 2014 (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.
Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. The purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy full term infants delivered by vaginal birth with an estimated gestational age of 37+1 to 41+6 weeks corrected gestational age
Key inclusion criteria (3 listed)
- Healthy full term infants
- Delivered by vaginal birth
- Estimated gestational age of 37+0to 41+6 weeks corrected gestational age
Key exclusion criteria (5 listed)
- Multiples
- Known fetal anomalies (including cardiac defects).
- Instrumentation during delivery (forceps or vacuum)
- Non-reducible nuchal cord during delivery.
- Any maternal or neonatal indication requiring immediate cord clamping.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac Output
Time frame: 5 minutes of Life
3 secondary outcomes
Stroke Volume
Time frame: 5 Minutes of Life
Bilirubin level
Time frame: until discharge
Hemoglobin level
Time frame: until discharge
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 20 May 2015.
- Derived from this study: PubMed 27057332Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015.
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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.
Anup Katheria, MD principal investigator
Sharp HealthCare
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 Cardiac Output, Low, run by Sharp HealthCare 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 5 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 20 May 2015. 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?
Cardiac Output (time frame: 5 minutes of Life). 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 NCT02195037, which also lists 1 linked publication.
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 20 May 2015.