Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372314
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Isoleucine Leucine Valine and Tryptophan Requirements in TPN Fed Neonates
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Isoleucine Leucine Valine and Tryptophan Requirements in Total Parenteral Nutrition TPN Fed Neonates
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates Using the Carbon Oxidation method indicator amino oxidation and direct amino acid oxidation method the investigators will determine the requirement of each of the 4 amino acids
The investigators will determine the requirement for Isoleucine Leucine Valine and Tryptophan The investigators will recruit 18- 20 babies per amino acid study Breath and urine samples will be collected to determine the oxidation of the indicator amino acid The response of the indicator amino acid to changes in intake of the test amino acid isoleucine leucine valine and tryptophan will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid It is hypothesized that the requirement for isoleucine leucine valine and tryptophan will be at least 50 lower than what is currently available in commercial solutions used for TPN feeding of neonates
The investigators will determine the requirement for Isoleucine Leucine Valine and Tryptophan The investigators will recruit 18- 20 babies per amino acid study Breath and urine samples will be collected to determine the oxidation of the indicator amino acid The response of the indicator amino acid to changes in intake of the test amino acid isoleucine leucine valine and tryptophan will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid It is hypothesized that the requirement for isoleucine leucine valine and tryptophan will be at least 50 lower than what is currently available in commercial solutions used for TPN feeding of neonates
Detailed Description:
The study is based on the carbon oxidation protocol Each baby will receive one or two levels of either isoleucine or leucine or valine or tryptophan Each level will be assessed over a two- day period
On day 1 each baby will receive a standard pediatric amino acid solution Primene used in the NICU and L-1-13CNa Bicarbonate will be given to measure carbon dioxide production
On day 2 heshe will receive the appropriate TPN Test Solution made up of the appropriate Bulk Amino Acid solution for Isoleucine Leucine Valine Tryptophan Studies with a different amount of the amino acid being investigated To see how these amino acids are used in the body the investigators will add a small amount calculated based on the body weight of the baby of the amino acid L-1-13Cphenylalanine to the amino acid solution Breath and urine will be collected from the baby to study the oxidation of the L -1-13Cphenylalanine The investigators will take 2 x 075 ml blood to measure plasma amino acid concentration The investigators will aim to coordinate blood taking with routine blood work done for clinical monitoring
On day 1 each baby will receive a standard pediatric amino acid solution Primene used in the NICU and L-1-13CNa Bicarbonate will be given to measure carbon dioxide production
On day 2 heshe will receive the appropriate TPN Test Solution made up of the appropriate Bulk Amino Acid solution for Isoleucine Leucine Valine Tryptophan Studies with a different amount of the amino acid being investigated To see how these amino acids are used in the body the investigators will add a small amount calculated based on the body weight of the baby of the amino acid L-1-13Cphenylalanine to the amino acid solution Breath and urine will be collected from the baby to study the oxidation of the L -1-13Cphenylalanine The investigators will take 2 x 075 ml blood to measure plasma amino acid concentration The investigators will aim to coordinate blood taking with routine blood work done for clinical monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None