Determination of Lysine Requirement in the Parenterally Fed Neonate

Not Applicable

Completed

• Conditions: Parenteral Lysine Requirements; Parenteral Feedings
• Interventions: Dietary Supplement: Amino Acid Solution with different amount of Lysine

• Registration Number: NCT00779753
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

The purpose of this study is to establish the parenteral lysine requirements for neonates.

Detailed Description

It is important to identify the appropriate level of lysine requirements for parenterally fed neonates as this amino acid is the limiting amino acid in the diet of neonates. Feeding lysine at requirement improves the likelihood that other amino acids will be utilized appropriately for building proteins. In addition, lysine plays a major role in calcium absorption, development of muscle proteins and in the production of hormones, enzymes and antibodies. We believe that the lysine requirement will be 158 mg/kg/day which is significantly lower than the current 267 and 327 mg/kg/d that is found in the current Trophamine and Primene parenteral solutions.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Clinically stable neonates on TPN
• minimum of 2.5 g/kg/d protein and 85 - 90 kcal/kg/d)
• Post conception age of ≥ 34 weeks gestation and appropriate for gestational age
• Weight of ≥ 1.5 kg
• NPO or ≤10% of total protein requirement consumed enterally

Exclusion Criteria

• Infants on mechanical ventilators, supplemental oxygen or who are receiving medications that would alter protein or energy metabolism (ie. corticosteroid therapy, etc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neonates	Amino Acid Solution with different amount of Lysine	Sixteen neonates admitted to the Neonatal Intensive Care Unit (NICU) at the Hospital for Sick Children (SickKids) will be required for this study. The diagnoses will include, but are not limited to, the following: Trachea-esophageal fistula and/or esophageal atresia, Congenital diaphragmatic hernia, imperforate anus, Hirschsprung's disease, Malrotation with or without volvulus, Intestinal atresias, Gastroschisis, Omphalocele, Necrotizing enterocolitis, Respiratory distress syndrome.

Primary Outcome Measures

Name	Time	Method
Oxydation of the Indicator Amino Acid L-[1-13C] phenylalanine will be measured through urine samples to determine urinary phenylalanine enrichment	2 days

Secondary Outcome Measures

Name	Time	Method
Breath samples will be collected for the measurement of CO2 enrichment in expired air	2 days

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada