Standardized Training System for ResidentsNCT03227302
Associations of the Grades of Doctor and Neonatal Outcomes
An observational study of Standardized Training System for Residents and Neonatal Outcomes, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
In China, the standardized training system for residents was built last year, and the associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear. Read more about this study
- Who is it for?
- Ages 1 minute to 100 days
- Conditions the study is for
- Standardized Training System for Residents, Neonatal Outcomes
- What is being tested?
- attending obstetrician, associate obstetrician and chief obstetrician
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Dec 2022
- 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 1 minute to 100 days
- All sexes
- Child
Study population: All neonates with gestational age are from 26 weeks to 42 weeks
Who may be able to join
- Gestational age (GA) is from 26 to 42 weeks
Who cannot join
- major congenital malformations or complex congenital heart disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Juan Ma, physician, 18680887330, zoe330@163.com
About this study
Official title: Associations of the Grades of Doctor and Neonatal Outcomes: An Observational Prospective Study
In China, the standardized training system for residents was built last year, and the associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.
Read the detailed description
In China, the grades of doctors and accoucheurs are divided into four levels, and different levels may induce differences of neonatal asphyxia and death. The standardized training system for residents was built last year,the associations of the grades of doctors and accoucheurs and neonatal asphyxia,neonatal death before and after the training systems need to be assess.
- Being tested
- attending obstetrician, associate obstetrician, chief obstetrician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attending obstetricianProcedure or surgery
Attending obstetrician can do the caesarean operation without pregnant complications.
associate obstetricianProcedure or surgery
Associate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications.
chief obstetricianProcedure or surgery
Chief obstetrician can do all caesarean operation without limitations.
| Study group | Role | What they receive |
|---|---|---|
| attending obstetrician | the low grade doctor who can do caesarean operation with no pregnant complications. Receives: Procedure: attending obstetrician | |
| associate chief obstetrician | The middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications. Receives: Procedure: associate obstetrician | |
| chief obstetrician | the high doctor who can do all caesarean operation without limitations Receives: Procedure: chief obstetrician |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal asphyxia
neonatal asphyxia was defined according to manual of neonatal care
Measured: within 28 days
death
neonatal death
Measured: within 28 days
Secondary outcomes (1)
Bayley Scales of Infant Development
to assess the development using Bayley Scales of Infant Development
Measured: at 2 months and 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Standardized Training System for ResidentsStudies 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Shi Yuan, PhD,MD, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227302
- Sponsor's protocol ID
- grades of doctor and neonaltal
- Status last verified
- Jan 2020
- First submitted
- 30 Jun 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of the Grades of Doctor and Neonatal Outcomes: An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT03227302
- Acronym / sponsor ID
- grades of doctor and neonaltal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 24 Jul 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.
In China, the standardized training system for residents was built last year, and the associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.
Detailed description
In China, the grades of doctors and accoucheurs are divided into four levels, and different levels may induce differences of neonatal asphyxia and death. The standardized training system for residents was built last year,the associations of the grades of doctors and accoucheurs and neonatal asphyxia,neonatal death before and after the training systems need to be assess.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| attending obstetrician | – | Procedure: attending obstetricianthe low grade doctor who can do caesarean operation with no pregnant complications. |
| associate chief obstetrician | – | Procedure: associate obstetricianThe middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications. |
| chief obstetrician | – | Procedure: chief obstetricianthe high doctor who can do all caesarean operation without limitations |
Who may qualify
- Ages
- 1 minute to 100 days
- Sex
- All
- Age groups
- Child
- Study population
- All neonates with gestational age are from 26 weeks to 42 weeks
Key inclusion criteria (1 listed)
- Gestational age (GA) is from 26 to 42 weeks
Key exclusion criteria (1 listed)
- major congenital malformations or complex congenital heart disease
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 |
|---|---|---|
| attending obstetricianAttending obstetrician can do the caesarean operation without pregnant complications. | Procedure or surgery | attending obstetrician |
| associate obstetricianAssociate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications. | Procedure or surgery | associate chief obstetrician |
| chief obstetricianChief obstetrician can do all caesarean operation without limitations. | Procedure or surgery | chief obstetrician |
Primary outcome
neonatal asphyxia
Time frame: within 28 days
neonatal asphyxia was defined according to manual of neonatal care
death
Time frame: within 28 days
neonatal death
1 secondary outcome
Bayley Scales of Infant Development
Time frame: at 2 months and 2 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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.
Shi Yuan, PhD,MD study director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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 Standardized Training System for Residents and Neonatal Outcomes, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University 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 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: status not confirmed, as of the sponsor's last update on 9 Jan 2020. 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?
Contact Ma Juan, MD (13883559467, 476679422@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal asphyxia (time frame: within 28 days). The study lists 2 primary outcomes in all. 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 9 Jan 2020.