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Nutrition Support for Hirschsprung Disease

Primary Purpose

Nutrition Supporting, Hirschsprung Disease, Infants

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
supplement nutritional supporting
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Supporting

Eligibility Criteria

0 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Children aged 0-2 years.
  2. Clinical diagnosis with Hirschsprung's disease who requires surgery;

Exclusion Criteria:

  1. Complicated with severe complications such as enterocolitis associated with Hirschsprung disease;
  2. History of diseases associated with various organ systems that may be life-threatening;
  3. Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child;
  4. Patients who have participated in other clinical trials within the last 1 month;
  5. Any other conditions in which the investigator considers it inappropriate to participate in the trial.

Sites / Locations

  • Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

Intravenous nutrition or oral high-calorie diet 7-10 days before surgery

normal diet before surgery

Outcomes

Primary Outcome Measures

rate of postoperative HAEC
Incidence of postoperative HAEC

Secondary Outcome Measures

Z score
weight/age
LOS
length of postoperative stay
reoperation
rate of reoperation
readmission
rate of readmission

Full Information

First Posted
October 18, 2020
Last Updated
April 3, 2023
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04598841
Brief Title
Nutrition Support for Hirschsprung Disease
Official Title
A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A multi-center, prospective,randomized, non-blind, controlled study was conducted to investigate the effects of different pre-operative nutritional support modes on perioperative nutritional status, surgical treatment success rate, and rehabilitation process in children with Hirschsprung disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Supporting, Hirschsprung Disease, Infants, Prospective Study

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Intravenous nutrition or oral high-calorie diet 7-10 days before surgery
Arm Title
control group
Arm Type
No Intervention
Arm Description
normal diet before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
supplement nutritional supporting
Intervention Description
Special medical formula for the purpose of formula food
Primary Outcome Measure Information:
Title
rate of postoperative HAEC
Description
Incidence of postoperative HAEC
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Z score
Description
weight/age
Time Frame
3 months
Title
LOS
Description
length of postoperative stay
Time Frame
1 months
Title
reoperation
Description
rate of reoperation
Time Frame
3 months
Title
readmission
Description
rate of readmission
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 0-5 years. Clinical diagnosis with Hirschsprung's disease who requires surgery; Exclusion Criteria: Complicated with severe complications such as enterocolitis associated with Hirschsprung disease; History of diseases associated with various organ systems that may be life-threatening; Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child; Patients who have participated in other clinical trials within the last 1 month; Any other conditions in which the investigator considers it inappropriate to participate in the trial.
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China

12. IPD Sharing Statement

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Nutrition Support for Hirschsprung Disease

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