SepsisHNEUNCT01045252
Study of Hemodynamics of Neonates by Echocardiography and USCOM
An observational study of Sepsis and Congenital Heart Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the hemodynamic values of neonates that are healthy and those with various congenital heart diseases and sepsis by using echocardiography and USCOM. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Sepsis, Congenital Heart Disease
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Dec 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 30 days
- All sexes
- No healthy volunteers
- Child
Study population: patients enrolled in the NICU of Guangdong General Hospital
Who may be able to join
- neonatal
- congenital heart disease
- sepsis
Who cannot join
- aged more than thirty days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Hemodynamics of Healthy Neonates and Those With Congenital Heart Diseases and Sepsis by Echocardiography and USCOM
The purpose of this study is to evaluate the hemodynamic values of neonates that are healthy and those with various congenital heart diseases and sepsis by using echocardiography and USCOM.
Read the detailed description
Echocardiography is a diagnostic tool for congenital heart disease.However,it requires skilled specialists to perform it and is a little expensive.Besides,it is too big to move to the bedside easily.USCOM is another newly choice to evaluate hemodynamic values in recent years.This study will compare the hemodynamic values of neonates that are healthy and those with congenital heart diseases and sepsis by using echocardiography and USCOM.
- Conditions
- Sepsis, Congenital Heart Disease
- Keywords
- hemodynamics, neonatal
- Medical subject headings
- Sepsis, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| congenital heart disease | Neonates that are enrolled in the NICU and are confirmed of congenital heart diseases. | |
| sepsis | Neonates that are enrolled in the NICU and are diagnosed as sepsis. | |
| Health | Neonates that are enrolled in the NICU and have no congenital heart diseases and sepsis. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shaoru He, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045252
- Sponsor's protocol ID
- CGGHHSR1132
- Acronym
- HNEU
- Status last verified
- Jan 2010
- First submitted
- 8 Jan 2010
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hemodynamics of Healthy Neonates and Those With Congenital Heart Diseases and Sepsis by Echocardiography and USCOM
- ClinicalTrials.gov ID
- NCT01045252
- Acronym / sponsor ID
- HNEU / CGGHHSR1132
- Conditions
- Sepsis, Congenital Heart Disease
- Keywords
- hemodynamics, neonatal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 Jan 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 purpose of this study is to evaluate the hemodynamic values of neonates that are healthy and those with various congenital heart diseases and sepsis by using echocardiography and USCOM.
Detailed description
Echocardiography is a diagnostic tool for congenital heart disease.However,it requires skilled specialists to perform it and is a little expensive.Besides,it is too big to move to the bedside easily.USCOM is another newly choice to evaluate hemodynamic values in recent years.This study will compare the hemodynamic values of neonates that are healthy and those with congenital heart diseases and sepsis by using echocardiography and USCOM.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| congenital heart disease | – | –Neonates that are enrolled in the NICU and are confirmed of congenital heart diseases. |
| sepsis | – | –Neonates that are enrolled in the NICU and are diagnosed as sepsis. |
| Health | – | –Neonates that are enrolled in the NICU and have no congenital heart diseases and sepsis. |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients enrolled in the NICU of Guangdong General Hospital
Key inclusion criteria (3 listed)
- neonatal
- congenital heart disease
- sepsis
Key exclusion criteria (1 listed)
- aged more than thirty days
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Shaoru He principal investigator
Guangdong Provincial People's Hospital
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 Sepsis and Congenital Heart Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 12 Jan 2010. 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 China. 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?
Results are not available in the source record.
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.
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 12 Jan 2010.