What side effects are associated with this type of intervention?

Common side effects of Total Parenteral Nutrition (TPN) include metabolic disturbances like electrolyte imbalances and hyperglycemia, liver dysfunction, and infections related to catheter use. Specific amino acid imbalances can also occur, leading to deficiencies or toxicities that affect metabolic stability.

What prior FDA approvals exist?

The FDA has approved several amino acid solutions for Total Parenteral Nutrition (TPN) to ensure that patients receive essential nutrients intravenously. These solutions typically contain a mix of essential and non-essential amino acids tailored to meet the nutritional needs of patients who cannot consume food orally or enterally. Products like TrophAmine, Aminosyn, and Clinimix are examples of such approved solutions. These formulations are designed to provide balanced nutrition, including essential amino acids like phenylalanine, methionine, and histidine, which are critical for protein synthesis and overall metabolic function.

What other types of research exist?

Promising novel alternatives to the Carbon Oxidation Method for determining amino acid requirements in TPN patients could include advanced metabolic profiling, which uses comprehensive metabolomics to assess individual nutritional needs, and genetic testing, which can provide insights into metabolic pathways and nutrient requirements. Additionally, machine learning algorithms that analyze patient data to predict personalized nutritional needs are emerging as innovative approaches.

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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

No Placebo-Only Group

Summary

This trial tests how much of three important nutrients newborns need when fed through a tube. It focuses on babies who rely on this type of nutrition and uses a method to see how their bodies use these nutrients.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hrs

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Amino Acids

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phenylalanine, methionine, histidine requirementExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Total Parenteral Nutrition (TPN) provides essential nutrients intravenously to patients who cannot consume food orally. The key components include amino acids, glucose, lipids, vitamins, and minerals. Amino acids are crucial as they serve as the building blocks for protein synthesis, which is vital for tissue repair and immune function. The trial using the Carbon Oxidation Method aims to determine the precise requirements for specific amino acids like phenylalanine, methionine, and histidine in neonates. Understanding these requirements ensures that TPN formulations can be optimized to meet the metabolic needs of patients, preventing deficiencies and promoting better clinical outcomes.

A comparison of essential and general amino acid infusions in protein-depleted patients receiving parenteral alimentation.Protein for the critically ill patient--what and when?Glutamine--from conditionally essential to totally dispensable?