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NCT Number: NCT06525753

Weaning is Winning? (WeWin Study)

We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).

Recruiting

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Key information

Conditions

Intestinal Failure Digestive System Diseases Gastrointestinal Diseases Hyperphagia Intestinal Diseases Parenteral Nutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location status: Recruiting

Location contact

Jessie Hulst

PRINCIPAL_INVESTIGATOR

Jessie Hulst, MD, PhD

CONTACT

[email protected]

Zujaja-Tul-Noor Zujaja-Tul-Noor, MSc

CONTACT

[email protected]

About this study

Children with IF depend on PN. This is associated with frequent and various complications such as metabolic bone disease, micronutrient deficiencies and abnormal body composition. Due to advancements in care, many patients with IF are able to wean off PN; they are so called PN graduates. It is currently not well known how often complications do occur after weaning off PN, and which patients are at highest risk of developing these complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
  • Age <18 years at time of inclusion.

Exclusion criteria

  • No consent provided.

Treatment and study plan

Weaning off Parenteral Nutrition

Other

pediatric intestinal failure patients who have been weaned off parenteral nutrition

Primary outcomes

  1. Complications

    Time frame: From 1 year after weaning off PN to 18 years of age

    Assess the frequency of nutritional complications including poor growth, micronutrient deficiencies, poor bone health, abnormal body composition, and delayed pubertal development in PN graduates.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Erasmus Medical Center

Registry information

Official study title

Weaning is Winning? (WeWin Study): Are Parenteral Nutrition (PN) Graduates Growing up Healthy?

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Jul 29, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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