Risk Factors of Perforated HSCR in Neonates | NCT05044741

Studies
Risk Factors of Perforated HSCR in Neonates

NCT05044741

Sponsor

Tongji Hospital

Status

Completed

Last Update Posted

Sep 16, 2021Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Hirschsprung Disease
Bowel; Perforation, Fetus or Newborn

Interventions

Emergency surgical enterostomy

Countries

Not provided

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2006Actual

Primary Completion Date

Dec 31, 2010Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Aug 27, 2021

First Submission Date that Met QC Criteria

Sep 5, 2021

First Posted Date

Sep 16, 2021Actual

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

Sep 5, 2021

Last Update Posted Date

Sep 16, 2021Actual

Name	Class
Wuhan Children's Hospital	OTHER
The First Affiliated Hospital of Zhengzhou University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Hirschsprung's disease (HSCR) is a common digestive malformation with radiographic evidence of distal bowel obstruction and clinical signs of abdominal distension, vomiting, constipation, and failure to pass meconium. Bowel perforation (perforated HSCR) is a very serious complication of HSCR, but if this occurs it is most often in the neonatal period. The current study collected information on all cases diagnosed with perforated HSCR from multi-centers in China over 10 years, the aim was to evaluate the clinical features of perforated HSCR, and investigate possible risk factors for perforated HSCR in neonates.

Detailed Description

Not provided

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

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Perforated group			Procedure: Emergency surgical enterostomy
Controlled group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emergency surgical enterostomy	Procedure	Emergency surgical enterostomy	Perforated group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of bowel perforation in neonatal Hirschsprung disease (perforated HSCR)	Cases with bowel perforation in neonatal Hirschsprung disease/ total neonatal Hirschsprung disease	14 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Neonates (≤1 month age)
Diagnosed with HSCR
Suffered with bowel perforation

Exclusion Criteria:

Patients complicated with suspected necrotizing enterocolitis (NEC), imperforate anus (IA), intestinal atresia, and meconium plug syndrome
Neonates who transferred from outside participating hospitals.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

30 Days

Standard Ages

Child

Study Population

-Neonates (≤1 month age) with HSCR who suffered with bowel perforation.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Until now, we do not have the plan to open individual participant data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006627	Hirschsprung Disease

Ancestor Terms

ID	Term
D004065	Digestive System Abnormalities
D004066	Digestive System Diseases
D008531	Megacolon
D003108	Colonic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided