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Amino Acid

Oral Threonine Supplementation for Infants on Tube Feeds (INFORALTHR Trial)

N/A
Waitlist Available
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Born between 32 and 43 weeks gestational age
Fed by nasogastric (NG), jejunal (J or NJ), or gastric (G) tube
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

INFORALTHR Trial Summary

This trial is testing how much of the amino acid threonine infants need when given it orally rather than intravenously.

Who is the study for?
This trial is for clinically stable infants aged 1-6 months, who are fed through a tube (NG, J or NJ, G) and were born between 32 and 43 weeks gestational age. Infants on supplemental oxygen, mechanical ventilation, with endocrine/genetic anomalies affecting protein metabolism or on medication like corticosteroids that influence protein/AA metabolism cannot participate.Check my eligibility
What is being tested?
The study aims to determine the oral threonine requirements in infants when they are fed enterally (through the mouth). It's part of a series investigating amino acid needs in infants. This phase follows Health Canada's new guidelines for preparing parenteral solutions.See study design
What are the potential side effects?
As this trial focuses on nutritional requirements rather than drug effects, specific side effects related to threonine intake aren't detailed but may include digestive disturbances if the amino acid isn't well-tolerated.

INFORALTHR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was born between 32 and 43 weeks of pregnancy.
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I am fed through a tube in my nose, stomach, or intestine.
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I am between 1 to 6 months old.

INFORALTHR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Threonine

INFORALTHR Trial Design

1Treatment groups
Experimental Treatment
Group I: Dietary Threonine IntakeExperimental Treatment1 Intervention
Physiological establishment of enteral intake of amino acid threonine required by infants ages 1 - 6 mos

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
682 Previous Clinical Trials
6,945,316 Total Patients Enrolled
Lisa Goos, PhDStudy ChairResearch Institute, Hospital for Sick Children

Media Library

Threonine (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT02364843 — N/A
Tracheoesophageal Fistula Research Study Groups: Dietary Threonine Intake
Tracheoesophageal Fistula Clinical Trial 2023: Threonine Highlights & Side Effects. Trial Name: NCT02364843 — N/A
Threonine (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02364843 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the opportunity to partake in this study currently available?

"Based on the info posted to clinicaltrials.gov, this medical trial is not presently accepting participants. It was initially listed back in February 2016 and last modified on January 14th 2022; however, there are still 136 other studies actively recruiting patients at present."

Answered by AI

Do applicants of this experiment need to adhere to an age limit?

"This research is open to infant participants between 1 and 6 months old."

Answered by AI

To what demographic is this investigation open?

"This research requires 18 neonates with hernias and diaphragmatic issues who are between 1 to 6 months old. To qualify, these infants should be clinically stable (normal vital signs & blood values) and have been born between 32–43 weeks gestation."

Answered by AI
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~1 spots leftby Dec 2024