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Amino Acid

Amino Acid Requirements in TPN for Neonates

N/A
Recruiting
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hrs
Awards & highlights

Study Summary

This trial will help determine how much of three essential amino acids neonates need when receiving total parenteral nutrition.

Who is the study for?
This trial is for stable newborns who are the right size for their age, born at or after 28 weeks of pregnancy, and are under 28 days old. They must be mostly fed through a vein (at least 90% of calories and protein) and not have any infections or serious health issues.Check my eligibility
What is being tested?
The study is testing how much of three amino acids - Phenylalanine, Methionine, Histidine - neonates need when they're getting all their nutrition through a vein. Researchers will use special methods to measure these needs in about 18-20 babies per amino acid.See study design
What are the potential side effects?
Since this trial involves nutritional support that's already standard care but with adjusted levels of certain amino acids, side effects may not be as common as drug trials. However, monitoring will occur for any unexpected reactions related to the modified nutrient intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hrs
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hrs for reporting.

Treatment Details

Study Objectives

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phenylalanine, methionine, histidine requirementExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
689 Previous Clinical Trials
6,945,361 Total Patients Enrolled

Media Library

Histidine (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT05562310 — N/A
Total Parenteral Nutrition Research Study Groups: Phenylalanine, methionine, histidine requirement
Total Parenteral Nutrition Clinical Trial 2023: Histidine Highlights & Side Effects. Trial Name: NCT05562310 — N/A
Histidine (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05562310 — N/A

Frequently Asked Questions

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

Is this experiment open to elderly individuals above the age of eighty-five?

"According to the criteria specified for eligibility, only neonates between 1 and 28 days old can be considered for this trial."

Answered by AI

How many subjects are currently enrolled in this research project?

"Affirmative. Clinicaltrials.gov data points to this trial as actively recruiting participants, which was initially announced on November 2nd 2022 and updated October 24th of that year. Currently, there is a need for 60 patients at 1 medical centre."

Answered by AI

Are physicians currently recruiting patients for this clinical investigation?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is actively looking for participants; it was first posted on November 2nd 2022 and edited most recently on October 24th of the same year. 60 test subjects need to be recruited from one location."

Answered by AI

Who meets the criteria to participate in this experiment?

"This trial is recruiting 60 preterm babies aged between one day and four weeks who are receiving total parenteral nutrition. Eligible applicants must be stable, have a birth weight and length appropriate for their gestational age, as well as having normal blood results with no fever or infection. Additionally, any baby that has undergone surgery in the past three days will not qualify for this study."

Answered by AI

Who else is applying?

What site did they apply to?
Glenda Courtney-Martin
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates
Glenda Courtney-Martin 2023. "Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05562310.
~40 spots leftby Sep 2026
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