120 Participants Needed

Weaning off Parenteral Nutrition for Intestinal Failure

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the experiences of children with intestinal failure who have successfully stopped using parenteral nutrition (feeding through an IV) for at least a year. The goal is to understand how well these children manage without this support. Researchers are collecting data from two hospitals in Canada and the Netherlands. Children who have transitioned off parenteral nutrition and previously experienced intestinal failure might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to valuable research that could enhance future care for children with similar conditions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that weaning off parenteral nutrition is safe for pediatric patients with intestinal failure?

Research has shown that stopping intravenous feeding, known as parenteral nutrition (PN), can be safe if done carefully. Sudden cessation might lead to low blood sugar, or hypoglycemia, so doctors recommend gradually reducing PN. Studies also indicate that some undernourished children might benefit from stopping PN early during a serious illness, rather than starting it immediately. However, risks remain, such as metabolic issues and problems with the IV lines. Overall, if managed well, gradually stopping PN can be safe and might offer benefits.12345

Why are researchers excited about this trial?

Researchers are excited about the "Weaning is Winning?" (WeWin) protocol because it explores innovative strategies for weaning pediatric patients off mechanical ventilation. Unlike traditional approaches that often rely on standard timing and gradual reduction methods, this trial investigates personalized weaning techniques tailored to the specific needs of each child. By focusing on individual patient responses, this method aims to enhance recovery times, reduce hospital stays, and improve overall outcomes for children in intensive care. This personalized approach could revolutionize how we manage pediatric respiratory support, offering hope for faster and more efficient recovery.

What evidence suggests that weaning off parenteral nutrition is effective for pediatric intestinal failure?

Research has shown that many children with intestinal failure can continue to grow well after discontinuing parenteral nutrition (PN), although significant catch-up growth is uncommon. This trial will explore the process of weaning children off PN. One study found that more than half of the children receiving PN at home successfully stopped it. Another study indicated that delaying the start of PN in undernourished, critically ill children was more beneficial than starting it immediately. These findings suggest that stopping PN might help some children manage their condition better. Overall, the potential benefits of reducing dependence on PN for children with intestinal failure are significant.678910

Are You a Good Fit for This Trial?

Inclusion Criteria

I stopped needing IV nutrition over a year ago but have had serious gut issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants are monitored for complications after weaning off parenteral nutrition

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

Follow-up

Participants are monitored for safety and effectiveness after the observation period

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Weaning off Parenteral Nutrition

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: SickKidsExperimental Treatment1 Intervention
Group II: ErasmusExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Erasmus MC-Sophia Children's Hospital

Collaborator

Trials
1
Recruited
120+

Erasmus University Medical Center (Erasmus MC) - Sophia Children's Hospital

Collaborator

Trials
1
Recruited
120+

Citations

Retrospective review of growth in pediatric intestinal failure ...

We observed stable growth with limited catch-up after PN weaning, with minimal variation by diagnosis, and during teduglutide therapy.

Outcomes of Delaying Parenteral Nutrition for 1 Week vs ...

Conclusions and Relevance. In undernourished critically ill children, withholding PN for 1 week was clinically superior to early PN. Trial ...

Outcome of home parenteral nutrition in 251 children over ...

By 31 December 2013, 52% of children were weaned off of HPN, 9% of the PDD subgroup had intestinal transplantation, and 10% died mostly because of immune ...

Early versus Late Parenteral Nutrition in Critically Ill Children

The results of our trial showed that withholding parenteral nutrition for 1 week in the pediatric ICU was clinically superior to providing early ...

Efficacy and Safety of Total Parenteral Nutrition in Pediatric ...

Parenteral nutrition is safe in pediatric patients. In properly selected pediatric patients, direct and indirect costs for such therapy may be significantly ...

Stopping parenteral nutrition - NCBI Bookshelf - NIH

Determining when parenteral nutrition (PN) can be stopped is important; there is risk of malnutrition and associated complications to the baby if parenteral ...

How to Safely Discontinue Parenteral Nutrition Therapy

Abruptly stopping TPN can lead to rebound hypoglycemia, characterized by dangerously low blood sugar levels. To mitigate this risk, healthcare ...

Outcomes of Delaying Parenteral Nutrition for 1 Week vs ...

The undernourished children benefited from withholding PN during the first week of critical illness as compared with initiating PN at the first ...

Prevention of complications for hospitalized patients receiving ...

In this review, we focus on potential metabolic and catheter-related complications associated with parenteral nutrition use.

The Hitchhiker's Guide to Parenteral Nutrition Management ...

Table 4 describes the advantages and disadvantages of intravenous access typically used for parenteral nutrition support.