Isoleucine, leucine, valine and tryptophan needs in newborns on TPN
Isoleucine, Leucine, Valine and Tryptophan Requirements in Total Parenteral Nutrition (TPN) Fed Neonates
This project will test how much isoleucine, leucine, valine, and tryptophan newborns who are fully fed by TPN need to support growth and normal metabolism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Santa Maria) |
| Trial ID | NCT06372314 on ClinicalTrials.gov |
What this trial studies
This multi-center project in two hospitals in Brazil uses the carbon oxidation (indicator amino acid oxidation) method to define requirements for four essential amino acids in neonates receiving nearly all nutrition by TPN. Each enrolled baby will receive one or two intake levels of a target amino acid over two-day periods, with L-[1-13C]phenylalanine added as the indicator and L-[1-13C]Na bicarbonate used to measure CO2 production. Investigators will collect breath, urine, and small blood samples and analyze the indicator amino acid response using a biphasic linear mixed-effect model to identify the breakpoint or mean requirement for each amino acid. The team plans about 18–20 infants per amino acid and hypothesizes requirements may be substantially lower than current commercial formulations.
Who should consider this trial
Good fit: Ideal candidates are medically stable neonates born at or after 28 weeks gestation, aged 28 days or less, who are receiving at least 90% of calories and protein via TPN and have normal lab results without infection or fever.
Not a fit: Babies who are mechanically ventilated or on significant respiratory support, small for gestational age, actively infected, receiving more than 10% of protein enterally, or on medications that alter amino acid metabolism are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the results could enable more precisely dosed neonatal TPN amino acid formulations that reduce excess intake and improve metabolic safety.
How similar studies have performed: The indicator amino acid oxidation technique is a validated method for defining amino acid needs in older populations and has been applied in infants before, but using it to set TPN-specific requirements for these four amino acids in fully TPN-fed neonates is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Santa Maria
- Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil — Santa Maria, Brazil (Recruiting)
Study contacts
- Study coordinator: Glenda Courtney-Martin, PhD
- Email: glenda.courtney-martin@sickkids.ca
- Phone: 416 813 5744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.