Assessing amino acid needs in neonates on total parenteral nutrition

Phenylalanine, Methionine and Histidine Requirements in Total Parenteral Nutrition (TPN) Fed Neonates

This study is trying to find out how much of three important amino acids babies on total parenteral nutrition need to stay healthy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 1 Day to 28 Days
• Sex: All
• Sponsor: The Hospital for Sick Children (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05562310 on ClinicalTrials.gov

What this trial studies

This project evaluates the requirements for three essential amino acids—phenylalanine, methionine, and histidine—in stable neonates receiving total parenteral nutrition (TPN). The study employs the Carbon Oxidation method to determine the specific needs for each amino acid by analyzing breath and urine samples from the participants. Each baby will undergo a two-day assessment with varying levels of the amino acids to establish their requirements. The results will help refine nutritional guidelines for TPN in neonates.

Who should consider this trial

Good fit: Ideal candidates are stable preterm babies who are fully TPN fed and medically stable.

Not a fit: Patients who are on mechanical ventilation or have unstable medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more tailored nutritional formulations for neonates, improving their growth and health outcomes.

How similar studies have performed: While this approach is based on established methods, the specific focus on these amino acids in TPN-fed neonates is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Stable preterm babies that are growing and fully TPN fed (at least 90% of calories and protein).
2. TPN providing adequate calories and protein as determined by attending physician and dietitian.
3. Babies born ≥ 28 weeks gestation,
4. ≤ 28 days chronological age at the time of the study,
5. Birth weight and length appropriate for gestational age,
6. Medically stable as determined by normal blood results and lack of a fever or infection,
7. At least 3 days after surgery, if the baby had a surgery.

Exclusion Criteria:

1. Babies on mechanical ventilation, on low flow oxygen and CPAP.
2. Small for gestational age,
3. On medications known to affect protein and amino acid metabolism,
4. Documented infection, fever
5. Unstable medical condition
6. Receiving enteral feeding providing \> 10% of protein intake.

Where this trial is running

Toronto, Ontario

• Glenda Courtney-Martin — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Glenda Courtney-Martin

Conditions: Stable Neonates, Receiving Total Parenteral Nutrition, Neonates, Total parenteral nutrition, Phenylalanine, Methionine, Histidine