Associations of the Grades of Doctor and Neonatal Outcomes | NCT03227302

Studies
Associations of the Grades of Doctor and Neonatal Outcomes

NCT03227302

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Status

Unknown status

Last Update Posted

Jan 9, 2020Actual

Enrollment

20,000Estimated

Phase

Not provided

Conditions

Standardized Training System for Residents
Neonatal Outcomes

Interventions

attending obstetrician
associate obstetrician
chief obstetrician

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Jun 30, 2017

First Submission Date that Met QC Criteria

Jul 21, 2017

First Posted Date

Jul 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2020

Last Update Posted Date

Jan 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ma Juan, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
attending obstetrician	the low grade doctor who can do caesarean operation with no pregnant complications.	Procedure: attending obstetrician
associate chief obstetrician	The middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications.	Procedure: associate obstetrician
chief obstetrician	the high doctor who can do all caesarean operation without limitations	Procedure: chief obstetrician

Interventions

Name	Type	Description	Arm Group Labels	Other Names
attending obstetrician	Procedure	Attending obstetrician can do the caesarean operation without pregnant complications.	attending obstetrician

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neonatal asphyxia	neonatal asphyxia was defined according to manual of neonatal care	within 28 days
death	neonatal death	within 28 days

Secondary Outcomes

Measure	Description	Time Frame
Bayley Scales of Infant Development	to assess the development using Bayley Scales of Infant Development	at 2 months and 2 years old

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age (GA) is from 26 to 42 weeks

Exclusion Criteria:

major congenital malformations or complex congenital heart disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

100 Days

Standard Ages

Child

Study Population

All neonates with gestational age are from 26 weeks to 42 weeks

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ma Juan, MD	Contact	13883559467		476679422@qq.com

Overall Officials

Name	Affiliation	Role
Shi Yuan, PhD,MD	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Daping Hospital, Third Military Medical University	Recruiting	Chongqing	Chongqing Municipality	400042	China