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Nutrition Support for Hirschsprung Disease

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ClinicalTrials.gov Identifier: NCT04598841
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

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

Condition or disease Intervention/treatment
Nutrition Supporting Hirschsprung Disease Infants Prospective Study Dietary Supplement: supplement nutritional supporting

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Multicentric Study on Perioperative Nutritional Support for Hirschsprung's Disease
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Dietary Supplement: supplement nutritional supporting
    Special medical formula for the purpose of formula food

Outcome Measures
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Primary Outcome Measures :
  1. Z score [ Time Frame: 2 years ]
    weight/ height


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infants diagnosed with Hirschsprung disease who need supplement nutritional support.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598841


Contacts
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Contact: Jiexiong Feng 0086-2783665309 fengjiexiong@126.com
Contact: Tianqi Zhu 0086-2783665309 zhutianqi84@163.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Tianqi Zhu    0086-27833665309    zhutianqi84@163.com   
Sponsors and Collaborators
Tongji Hospital
More Information
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Responsible Party: Jiexiong Feng, professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04598841    
Other Study ID Numbers: TJH-HSCRNS
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities